Immunisation Handbook

NOTES
RECOGNITION AND TREATMENT OF ANAPHYLAXIS
CONTACT DETAILS FOR AUSTRALIAN, STATE AND TERRITORY GOVERNMENT

HEALTH AUTHORITIES
Signs of anaphylaxis
Anaphylaxis causes respiratory and/or cardiovascular signs or symptoms AND involves other organ systems, such as the skin or gastrointestinal
tract, with:
Australian Government health authorities
signs of airway obstruction, such as cough, wheeze, hoarseness, stridor or signs of respiratory distress (e.g. tachypnoea, cyanosis,
rib recession)
upper airway swelling (lip, tongue, throat, uvula or larynx)
tachycardia, weak/absent carotid pulse
hypotension that is sustained and with no improvement without specific treatment (Note: in infants and young children limpness and
pallor are signs of hypotension)
loss of consciousness with no improvement once supine or in head-down position
skin signs, such as pruritus (itchiness), generalised erythema (redness), urticaria (weals) or angioedema (localised or general swelling of
the deeper layers of the skin or subcutaneous tissue)
abdominal cramps, diarrhoea, nausea and/or vomiting
sense of severe anxiety and distress.
Australian Government
Department of Health
www.health.gov.au
All information in this publication is
correct as at January 2014
<1 year (approx. 510 kg)
0.050.1mL
710years (approx. 30kg)
0.3mL
0.1mL
0.4mL
0.15mL
>12 years and adult (over 50 kg)
0.5mL
0.2mL
For more detailed information, see 2.3.2 Adverse events following immunisation.
* Modified from The Brighton Collaboration Case Definition Criteria for Anaphylaxis, and an insert published in Australian Prescriber in August
2011 (available at www.australianprescriber.com/magazine/34/4/article/1210.pdf).
10613 January 2014
Doses of 1:1000 (one in one thousand) adrenaline:
1300 066 055

(to connect to your local Public Health Unit)
Northern Territory
08 8922 8044
Centre for Disease Control
Queensland
13 HEALTH (13 4325 84)

Contact your local Public Health Unit, details at
www.health.qld.gov.au/cdcg/contacts.asp
South Australia
1300 232 272 (8.30 am to 5.00 pm)

Email: [email protected]
O N
The following table lists the doses of 1:1000 adrenaline to be used if the exact weight of the person is not known (based on the persons age).
New South Wales
www.sahealth.sa.gov.au
Tasmania
03 6222 7666 or 1800 671 738
Victoria
1300 882 008

www.health.vic.gov.au/immunisation
Western Australia
08 9388 4868
08 9328 0553 (after hours Infectious Diseases Emergency)
The use of 1:1000 adrenaline is recommended because it is universally available. Adrenaline 1:1000 contains 1mg of adrenaline per mL of
solution in a 1mL glass vial. Use a 1mL syringe to improve the accuracy of measurement when drawing up small doses.
10th Edition 2013 (updated January 2014)
S A T
The recommended dose of 1:1000 adrenaline is 0.01mL/kg body weight (equivalent to 0.01mg/kg), up to a maximum of 0.5mL or 0.5mg,
given by deep intramuscular injection into the anterolateral thigh. Adrenaline 1:1000 must not be administered intravenously.
The Australian
Immunisation Handbook
02 6205 2300
Immunisation Enquiry Line
Adrenaline dosage
State and territory government health authorities

Australian Capital Territory
M M U N
Antihistamines and/or hydrocortisone are not recommended for the emergency management of anaphylaxis.
Freecall: 1800 671 811

www.immunise.health.gov.au
If the patient is unconscious, lie him/her on the left side and position to keep the airway clear. If the patient is conscious, lie supine in
head-down and feet-up position (unless this results in breathing difficulties).
Give adrenaline by intramuscular injection (see below for dosage) if there are any signs of anaphylaxis with respiratory and/or
cardiovascular symptoms or signs. Although adrenaline is not required for generalised non-anaphylactic reactions (such as skin rash
without other signs or symptoms), administration of intramuscular adrenaline is safe.
Call for assistance. Never leave the patient alone.
If oxygen is available, administer by facemask at a high flow rate.
If there is no improvement in the patients condition within 5 minutes, repeat doses of adrenaline every 5 minutes, until
improvement occurs.
Check breathing; if absent, commence basic life support or appropriate cardiopulmonary resuscitation (CPR) as per the Australian
Resuscitation Council guideline (www.resus.org.au/policy/guidelines).
Transfer all cases to hospital for further observation and treatment.
Complete full documentation of the event, including the time and dose(s) of adrenaline given.
Experienced practitioners may choose to use an oral airway, if the appropriate size is available, but its use is not routinely recommended,
unless the patient is unconscious.
The Australian Immunisation Handbook 10th Edition 2013
Management of anaphylaxis
02 6289 1555
For changes introduced in the

10th edition of the Handbook,
see 1.4 Whats new
NOTES

HEALTH AUTHORITIES
tract, with:
rib recession)
www.health.gov.au
0.050.1mL
0.3mL
0.1mL
0.4mL
0.15mL
0.5mL
0.2mL
10613 January 2014
1300 066 055

Northern Territory
08 8922 8044
Queensland
13 HEALTH (13 4325 84)

South Australia
1300 232 272 (8.30 am to 5.00 pm)

O N
New South Wales
Tasmania
03 6222 7666 or 1800 671 738
Victoria
1300 882 008

Western Australia
08 9388 4868
S A T
The Australian
02 6205 2300
Adrenaline dosage

M M U N
Freecall: 1800 671 811

improvement occurs.
02 6289 1555

see 1.4 Whats new
How to manage injection site discomfort
Managing fever after immunisation
Concerns
Many vaccine injections may result in soreness, redness,

itching, swelling or burning at the injection site for 1 to 2 days.
Paracetamol might be required to ease the discomfort.
Sometimes a small, hard lump (nodule) at the injection
site may persist for some weeks or months. This should
not be of concern and requires no treatment.
Give extra fluids to drink. Do not overdress the baby if hot.

Although routine use of paracetamol after vaccination is
not recommended, if fever is present, paracetamol can be
given. The dose of paracetamol for a child up to 12 years of
age is 15mg/kg/dose, every 4 to 6 hours, up to four times a
day. Adults and children aged 12 years can receive 500 to
1000mg every 4 to 6 hours. Paracetamol should not be given
for more than 48 hours without seeking medical advice.
If you are worried about yourself or your childs condition after

a vaccination, see your doctor or immunisation nurse as soon as
possible, or go directly to a hospital. It is also important to seek
medical advice if you or your child are unwell, as this may be
due to other illness rather than because of the vaccination.
DTPa
dTpa
HepA
HepB
Hib
HPV
Influenza
IPV
diphtheria-tetanus-pertussis acellular (infant/child formulation)

diphtheria-tetanus-pertussis acellular (reduced antigen content formulation)
hepatitis A vaccine
hepatitis B vaccine
Haemophilus influenzae type b vaccine
human papillomavirus vaccine
influenza or flu vaccine
inactivated poliomyelitis vaccine
MenCCV
MMR
MMRV
13vPCV
23vPPV
Rotavirus
VV
meningococcal C conjugate vaccine

measles-mumps-rubella vaccine
measles-mumps-rubella-varicella vaccine
pneumococcal conjugate vaccine (13 serotypes)
pneumococcal polysaccharide vaccine (23 serotypes)
rotavirus vaccine
varicella vaccine
Key to table
Diphtheria-tetanus-pertussis (acellular)
DTPa-containing vaccines and dTpa
(reduced antigen) vaccines
Haemophilus influenzae type b vaccine (Hib)
Hepatitis A vaccine (HepA)
Hepatitis B vaccine (HepB)
Localised pain, redness and

swelling at injection site
Occasionally, an injection-site nodule; may
last many weeks; no treatment needed
Low-grade temperature (fever)
In children, the following may also occur:
Irritable, crying, unsettled and
generally unhappy
Drowsiness or tiredness


Localised pain, redness and swelling at

injection site
Human papillomavirus vaccine (HPV)
Influenza vaccine
Measles-mumps-rubella vaccine
(MMR, MMRV see also varicella)
Meningococcal C conjugate vaccine (MenCCV)

Mild headache
Mild nausea
Muscle aches

Seen 710 days after vaccination:
Temperature (fever, can be >39.4C),
lasting 23 days, faint red rash (not
infectious), head cold and/or runny
nose, cough and/or puffy eyes
Swelling of salivary glands

generally unhappy
Loss of appetite
Headache (usually observed
in adolescents/adults)
Pneumococcal vaccines (conjugate

13vPCV and polysaccharide 23vPPV)
Inactivated poliomyelitis vaccine

(IPV) and IPV-containing vaccines
Rotavirus vaccine
Varicella vaccine (VV)

Muscle aches
Vomiting and diarrhoea can occur up

to 7 days following vaccination

Temperature (fever, can be >39C)
Pustular rash (25 lesions), usually at
injection site, occasionally elsewhere
If the adverse event following immunisation is unexpected, persistent and/or severe, or if you are worried about your or your childs condition, see your doctor or immunisation nurse as soon as possible, or go
directly to a hospital. Adverse events that occur following immunisation may be reported to the Therapeutic Goods Administration (TGA) (www.tga.gov.au) or to the Adverse Medicines Events line on 1300 134 237,
or discuss with your immunisation provider as to how reports are submitted in your state or territory.
Common adverse events following immunisation are usually mild and temporary (occurring in the first few days after vaccination, unless otherwise stated). Specific treatment is not usually required (see below).
Side effects following immunisation for vaccines used in the National Immunisation Program (NIP) schedule
INFORMATION SHEET ADVERSE EVENTS FOLLOWING IMMUNISATION

INFORMATION SHEET COMPARISON OF THE EFFECTS OF DISEASES AND THE SIDE EFFECTS OF NIP VACCINES
From The Australian Immunisation Handbook 10th Edition (see Handbook contents for more details)
DISEASE
EFFECT OF DISEASE
SIDE EFFECT OF VACCINE
About 1 in 5 has a local reaction or fever. About 3 to 5 in 100 may develop

a mild varicella-like rash. Serious adverse events are very rare.
One in 100 000 patients develops encephalitis (brain inflammation).

Infection during pregnancy can result in congenital malformations in
the baby. Infection in the mother around delivery time results in severe
infection in the newborn baby in up to one-third of cases.
Varicella (chickenpox) highly contagious virus; causes

low-grade fever and vesicular rash (fluid-filled spots).
Reactivation of the virus later in life causes herpes zoster
(shingles).
About 1 in 10 has local swelling, redness or pain at the injection site, or

fever (DTPa/dTpa vaccine). Booster doses of DTPa may occasionally be
associated with extensive swelling of the limb, but this resolves completely
within a few days. Serious adverse events are very rare.
About 2 in 100 patients die. The risk is greatest for the very young or old.
Tetanus caused by toxin of bacteria in soil; causes painful

muscle spasms, convulsions, lockjaw.
About 1 in 10 has local swelling, redness or pain at the injection site.

About 1 in 20 has swollen glands, stiff neck or joint pains. About 1 in
20 has a rash, which is non-infectious.
Low platelet count (causing bruising or bleeding) occurs
after the1st dose of MMR vaccine, at a rate of about 1 in 20 000 to 30 000.
Serious adverse events are very rare.
Patients typically develop a rash, painful swollen glands and painful joints.
One in 3000 develops low platelet count (causing bruising or bleeding);
1 in 6000 develops encephalitis (brain inflammation).
Up to 9 in 10 babies infected during the first trimester of pregnancy
will have a major congenital abnormality (including deafness,
blindness or heart defects).
Rubella virus spread by respiratory droplets; causes fever,

rash and swollen glands, but causes severe malformations in
babies of infected pregnant women.
Up to 3 in 100 may develop diarrhoea or vomiting in the week after

receiving the vaccine.
About 1 in 17 000 babies may develop intussusception in the
first few weeks after the 1st or 2nd vaccine doses.
Illness may range from mild diarrhoea to severe dehydrating diarrhoea

and fever, which can result in death.
Of children under 5 years of age, before vaccine introduction,
approximately 10 000 children were hospitalised, 115 000 needed
GP visits and 22 000 required an Emergency Department visit each
year in Australia.
Rotavirus virus spread by faecaloral route; causes

gastroenteritis, which can be severe.
Local redness, pain and swelling at the injection site are common. Up to
1 in 10 has fever, crying and decreased appetite. Serious adverse events
are very rare.
While many infections cause no symptoms, up to 3 in 10 patients

with paralytic polio die, and many patients who survive are
permanently paralysed.
Polio virus spread in faeces and saliva; causes fever,

headache and vomiting and may progress to paralysis.

fever (conjugate vaccine).
Up to 1 in 2 has local swelling, redness or pain at the injection
site (polysaccharide vaccine).
About 3 in 10 people with meningitis die.

One-third of all pneumonia cases and up to half of pneumonia
hospitalisations in adults is caused by pneumococcal infection.
Pneumococcal infection bacteria spread by respiratory

droplets; causes septicaemia (infection of the blood stream),
meningitis (infection of the tissues surrounding the brain)
and occasionally other infections.

associated with extensive swelling of the limb, but this resolves
completely within a few days. Serious adverse events are very rare.
About 1 in 125 babies under the age of 6 months with whooping

cough dies from pneumonia or brain damage.
Pertussis bacteria spread by respiratory droplets; causes

whooping cough, with prolonged cough lasting up to 3
months.
About 1 in 100 may develop swelling of the salivary glands. Serious

adverse events are very rare.
One in 5000 children develops encephalitis (brain inflammation).

One in 5 males (adolescent/adult) develop inflammation of the testes.
Occasionally, mumps causes infertility or permanent deafness.
Mumps virus spread by saliva; causes swollen neck and

salivary glands, and fever.
About 1 in 10 has local swelling, redness or pain at the

injection site, fever, irritability, loss of appetite or headaches (conjugate
vaccines).
About 1 in 2 has a local reaction (polysaccharide vaccine).
About 1 in 10 patients dies. Of those that survive, 1 to 2 in 10 have

permanent long-term problems, such as loss of limbs and brain
damage.
Meningococcal infection bacteria spread by respiratory

droplets; causes septicaemia (infection of the blood stream)
and meningitis (infection of the tissues surrounding the
brain).

injection site, or fever. About 1 in 20 develops a rash, which is noninfectious.
Low platelet count (causing bruising or bleeding) occurs after the 1st dose
of MMR vaccine at a rate of about 1 in 20 000 to 30 000. Serious adverse
events are very rare.
About 1 in 15 children with measles develops pneumonia and 1 in

1000 develops encephalitis (brain inflammation). For every 10 children
who develop measles encephalitis, 1 dies and many have permanent
brain damage. About 1 in 100 000 develops SSPE (brain degeneration),
which is always fatal.
Measles highly infectious virus spread by respiratory

droplets; causes fever, cough and rash.

Fever occurs in about 1 in 10 children aged 6 months to 3 years.
Guillain-Barr syndrome occurs in about 1 in 1 million. Serious adverse
There are an estimated 3000 deaths in people older than 50 years of

age each year in Australia.
Causes increased hospitalisation in the very young (under 5 years of
age) and the elderly. Other high-risk groups include pregnant women,
people who are obese, diabetics and others with certain chronic
medical conditions.
Influenza virus spread by respiratory droplets; causes

fever, muscle and joint pains, pneumonia. About 1 in 10 to
1 in 5 persons will get influenza every year.
About 8 in 10 will have pain and 2 in 10 will have local swelling,

redness or pain at the injection site. Headache, fever, muscle aches and
tiredness may occur in up to 3 in 10 people. Serious adverse events are
very rare.
About 7 in 10 cervical cancers worldwide have been associated with

HPV-16 and 1 in 6 with HPV-18.
Human papillomavirus virus spread mainly via sexual

contact; up to 80% of the population will be infected
with HPV at some time in their lives. Some HPV types are
associated with the development of cancer.

About 1 in 50 has fever. Serious adverse events are very rare.
About 1 in 20 meningitis patients dies and about 1 in 4 survivors has

permanent brain or nerve damage. Epiglottitis is rapidly and invariably
fatal without treatment.
Hib bacteria spread by respiratory droplets; causes

meningitis (infection of the tissues surrounding the brain),
epiglottitis (respiratory obstruction), septicaemia (infection
of the blood stream) and septic arthritis (infection in the
joints).
About 1 in 20 will have local swelling, redness or pain at the injection site
and 2 in 100 will have fever. Anaphylaxis occurs in about 1 in 1 million.
About 1 in 4 chronic carriers will develop cirrhosis or liver cancer.
Hepatitis B virus spread mainly by blood, sexual contact

or from mother to newborn baby; causes acute hepatitis
(liver infection) or chronic infection (carrier).
About 1 in 5 will have local swelling, redness or pain at the injection

site. Serious adverse events are very rare.
At least 7 in 10 adult patients develop jaundice (yellowing of the skin and

eyes), fever, anorexia (decreased appetite), nausea, vomiting, hepatic
(liver) pain and malaise (tiredness).
Hepatitis A virus spread by contact or ingestion of faecally

contaminated water/food or through contact with the faecal
material of a person infected with hepatitis A.

Up to 1 in 7 patients die. The bacteria release a toxin, which can

produce nerve paralysis and heart failure.
Diphtheria bacteria spread by respiratory droplets; causes

severe throat and breathing difficulties.
Immunisation
Handbook
th Edition 2013
th
(updated January 2014)
S A T
10
M M U N
The Australian
i
O N
Copyright
The Australian Immunisation Handbook 10th edition 2013 (updated January 2014)
ISBN: 978-1-74241-861-2
Online ISBN: 978-1-74241-862-9
Publications approval number: 10613
Copyright statements:
Paper-based publications
Commonwealth of Australia 2013
This work is copyright. You may reproduce the whole or part of this work in unaltered form
for your own personal use or, if you are part of an organisation, for internal use within your
organisation, but only if you or your organisation do not use the reproduction for any commercial
purpose and retain this copyright notice and all disclaimer notices as part of that reproduction.
Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright
notice, all other rights are reserved and you are not allowed to reproduce the whole or any part
of this work in any way (electronic or otherwise) without first being given the specific written
permission from the Commonwealth to do so. Requests and inquiries concerning reproduction
and rights are to be sent to the Communication Branch, Department of Health, GPO Box 9848,
Canberra ACT 2601, or via e-mail to [email protected].
Internet sites
Commonwealth of Australia 2013
This work is copyright. You may download, display, print and reproduce the whole or part of this
work in unaltered form for your own personal use or, if you are part of an organisation, for internal
use within your organisation, but only if you or your organisation do not use the reproduction
for any commercial purpose and retain this copyright notice and all disclaimer notices as part of
that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed
by this copyright notice, all other rights are reserved and you are not allowed to reproduce the
whole or any part of this work in any way (electronic or otherwise) without first being given
the specific written permission from the Commonwealth to do so. Requests and inquiries
concerning reproduction and rights are to be sent to the Communication Branch, Department
of Health, GPO Box 9848, Canberra ACT 2601, or via e-mail to [email protected].
These guidelines were approved by the Chief Executive Officer (CEO) of the National Health and
Medical Research Council (NHMRC) on 25/01/2013 (with minor amendments approved by the
CEO on 19/12/2013), under Section 14A of the National Health and Medical Research Council Act
1992. In approving these guidelines the NHMRC considers that they meet the NHMRC standard
for clinical practice guidelines. This approval is valid for a period of five years.
NHMRC is satisfied that they are based on the systematic identification and synthesis of the
best available scientific evidence and make clear recommendations for health professionals
practising in an Australian health care setting. The NHMRC expects that all guidelines will be
reviewed no less than once every five years.
This publication reflects the views of the authors and not necessarily the views of the
Australian Government.
ii The Australian Immunisation Handbook 10th edition (updated January 2014)
THE AUSTRALIAN IMMUNISATION HANDBOOK

10TH EDITION (UPDATED JANUARY 2014)
WHATS NEW IN THE 2014 UPDATE
The 2014 update of the 10th edition of The Australian Immunisation Handbook
contains minor amendments to the version published in February 2013. There has
been no change to any vaccine recommendations. Page numbering, sectioning
and indexing remain the same.
Changes made between the 9th and 10th editions of The Australian Immunisation
Handbook are listed in a separate section in this Handbook (see 1.4 Whats new).
Changes in this update

A summary of the changes made in this update is provided below.
A more detailed description of these changes is available on the Immunise
Australia website (www.immunise.health.gov.au/internet/immunise/
publishing.nsf/Content/Handbook10-home).
Summary of changes
Updated details of where to find information on smallpox (page 7)
Updated link to the new (2nd) edition of the National vaccine storage guidelines:
Strive for 5 (page 25)
Correction of the age for which children only need 1 dose of Hib vaccine as
catch-up (pages 42 and 195)
Correction of the minimum interval between doses of MenCCV in Table 2.1.5
(page 47)
Correction of the minimum acceptable age for the 1st dose of DTPa vaccine in
Table 2.1.5 footnote () (page 48)
Correction and new format of Table 2.1.8 to more clearly present catch-up
recommendations for Hib vaccination for children <5 years of age (pages
5455)
Clarification of the text outlining how to use palm placement to identify the
ventrogluteal injection site in conjunction with Figure 2.2.7 (page 81)
Updated value for the estimated excess number of intussusception cases
attributable to rotavirus vaccination(pages 93 and 382)
Correction of the INR cut-off for deferral of intramuscular vaccination (page
168)
Clarification on the exposures that increase the risk of hepatitis B among
certain occupations(pages 170, 223 and 225)
iii
Updated upper age limit for which refugees may have been offered MMR
vaccine as part of a pre-departure health check (page 174)
Clarification of the recommended timing of the 3rd dose of hepatitis B
vaccine (not including birth dose) in infants born to mothers who are HBsAgpositive in Table 4.5.3 (page 229)
Clarification on the acceptable minimum age for the 1st dose of MMR vaccine
(page 272), to be consistent with footnote in Table 2.1.5
Updated age range for which 13vPCV (Prevenar 13) is registered in children
(pages 323 and 336)
Corrections of minor editorial issues, including grammatical, typographical
and formatting issues
Any future updates of the 10th edition of The Australian Immunisation

Handbook will be made online and notified through immunisation
provider networks. Online updates can be accessed via the Immunise
Australia website: www.immunise.health.gov.au/internet/immunise/
publishing.nsf/Content/Handbook10-home
iv The Australian Immunisation Handbook 10th edition (updated January 2014)
TABLE OF CONTENTS
PART 1 INTRODUCTION TO THE AUSTRALIAN IMMUNISATION HANDBOOK1
1.1 Background
1.2
Development of the 10th edition of the Handbook3
1.3
How to use the 10th edition Handbook5
1.4
Whats new
1.5
Fundamentals of immunisation
PART 2 VACCINATION PROCEDURES
7
18
24
2.1 Pre-vaccination
24
2.2
65
Administration of vaccines
2.3 Post-vaccination
85
PART 3 VACCINATION FOR SPECIAL RISK GROUPS
104
3.1
Vaccination for Aboriginal and Torres Strait Islander people
104
3.2
Vaccination for international travel
113
3.3
Groups with special vaccination requirements
130
PART 4 VACCINE-PREVENTABLE DISEASES
176
4.1 Cholera
176
4.2 Diphtheria
182
4.3
Haemophilus influenzae type b
191
4.4
Hepatitis A
198
4.5
Hepatitis B
208
4.6
Human papillomavirus
231
4.7 Influenza
243
4.8
259
Japanese encephalitis
4.9 Measles
267
4.10
283
Meningococcal disease
4.11 Mumps
295
4.12 Pertussis
302
4.13
317
Pneumococcal disease
4.14 Poliomyelitis
338
4.15
Q fever
345
4.16
Rabies and other lyssaviruses (including Australian bat lyssavirus)
353
4.17 Rotavirus
372
4.18 Rubella
384
4.19 Tetanus
397
4.20 Tuberculosis
408
4.21 Typhoid
416
4.22 Varicella
423
4.23
Yellow fever
439
4.24
Zoster (herpes zoster)
446
PART 5 PASSIVE IMMUNISATION
456
5.1
456
Passive immunisation using immunoglobulin preparations
APPENDICES465
APPENDIX 1: C
ontact details for Australian, state and territory government
health authorities and communicable disease control
465
APPENDIX 2: Literature search strategy for the 10th edition of the Handbook467
APPENDIX 3: C
omponents of vaccines used in the National
Immunisation Program
469
APPENDIX 4: Commonly asked questions about vaccination
473
A.4.1 General questions
473
A4.2 Questions about contraindications and precautions
477
A4.3 Questions about vaccine safety
481
A4.4 Questions about vaccine content
484
A4.5 Questions about the need for immunisation
487
A4.6 Further information about vaccination
488
APPENDIX 5: Glossary of technical terms
489
APPENDIX 6: Commonly used abbreviations
495
APPENDIX 7: Overview of vaccine availability in Australia
498
INDEX500
vi The Australian Immunisation Handbook 10th edition (updated January 2014)
LIST OF TABLES
Table 2.1.1: Pre-vaccination screening checklist
30
Table 2.1.2: Responses to relevant conditions or circumstances identified

through the pre-vaccination screening checklist
31
Table 2.1.3: Live attenuated parenteral and oral vaccines
37
Table 2.1.4: False contraindications to vaccination
38
Table 2.1.5: Minimum acceptable age for the 1st dose of scheduled vaccines
in infants in special circumstances
46
Table 2.1.6: Number of vaccine doses that should have been administered
by the current age of the child
49
Table 2.1.7: Minimum acceptable dose intervals for children <10 years of age 50
Table 2.1.8: Catch-up schedule for Haemophilus influenzae type b (Hib)
vaccination for children <5 years of age
54
Table 2.1.9: Catch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous
children, and Indigenous children residing in the Australian
Capital Territory, New South Wales, Tasmania and Victoria,
who do not have any medical condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD), aged
<5 years
56
Table 2.1.10: Catch-up schedule for 13vPCV (Prevenar 13) for Indigenous
children residing in the Northern Territory, Queensland,
South Australia or Western Australia ONLY, who do not have
any medical condition(s) associated with an increased risk of
invasive pneumococcal disease (IPD), aged <5 years
57
Table 2.1.11: Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV
(Pneumovax 23) in children with a medical condition(s)
associated with an increased risk of invasive pneumococcal
disease (IPD), presenting at age <2 years
59
Table 2.1.12: Catch-up schedule for persons 10 years of age (for vaccines
recommended on a population level)
63
Table 2.2.1: Route of administration for vaccines used in Australia
68
Table 2.2.2: Recommended needle size, length and angle for administering
vaccines72
Table 2.3.1: Clinical features that may assist differentiation between a
vasovagal episode and anaphylaxis
88
Table 2.3.2: Doses of intramuscular 1:1000 (one in one thousand) adrenaline

for anaphylaxis
90
Table 2.3.3: Contact information for notification of adverse events following

immunisation96
vii
Table 3.1.1: Additional vaccines recommended for Indigenous persons,

due to their higher risk of disease
105
Table 3.2.1: Dose and routes of administration of commonly used vaccines

in adult travellers
123
Table 3.2.2: Recommended lower age limits of travel vaccines for children
127
Table 3.3.1: Recommendations for vaccination in pregnancy
135
Table 3.3.2: Recommendations for vaccinations for solid organ transplant

(SOT) recipients
151
Table 3.3.3: Recommendations for revaccination following haematopoietic

stem cell transplant (HSCT) in children and adults, irrespective
of previous immunisation history
156
Table 3.3.4: Categories of immunocompromise in HIV-infected persons, based
on age-specific CD4+ counts and percentage of total lymphocytes 158
Table 3.3.5: Recommendations for vaccination in persons with functional or
anatomical asplenia
163
Table 3.3.6: Recommended intervals between either immunoglobulins or
blood products and measles-mumps-rubella (MMR), measlesmumps-rubella-varicella (MMRV) or varicella vaccination
167
Table 3.3.7: Recommended vaccinations for persons at increased risk of

certain occupationally acquired vaccine-preventable diseases
170
Table 4.4.1: Recommended doses and schedules for use of inactivated

hepatitis A and hepatitis A combination vaccines
202
Table 4.5.1: Recommended schedules for use of monovalent hepatitis B and

hepatitis B combination vaccines
214
Table 4.5.2: Accelerated hepatitis B vaccination schedules (for persons
with imminent risk of exposure)
216
Table 4.5.3: Post-exposure prophylaxis for non-immune persons exposed

to a HBsAg-positive source
229
Table 4.7.1: Recommended doses of influenza vaccine
251
Table 4.9.1: Recommendations for measles vaccination with (a) measlesmumps-rubella (MMR) (currently available), and (b) once
measles-mumps-rubella-varicella (MMRV) vaccines are available
from July 2013
273
Table 4.9.2: Post-exposure prophylaxis 72 hours since exposed to measles
for non-immune individuals (adapted from Measles: national
guidelines for public health units)281
Table 4.13.1: Recommendations for pneumococcal vaccination for children
aged <5 years
viii The Australian Immunisation Handbook 10th edition (updated January 2014)
325
List 4.13.1: Conditions associated with an increased risk of invasive

pneumococcal disease (IPD) in children and adults, by severity
of risk
326
Table 4.13.2: Recommendations for pneumococcal vaccination for children

aged 25 years with a medical condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD)
328
Table 4.13.3: Recommendations for pneumococcal vaccination using 23vPPV

for adults who do not have a condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD)
332
Table 4.15.1: Interpretation and action for serological and skin test results
(with modifications from A guide to Q fever and Q fever vaccination
(CSL Biotherapies, 2009))
350
Table 4.16.1: Lyssavirus exposure categories
360
Table 4.16.2: Post-exposure prophylaxis commenced overseas and

recommended completion in Australia
365
Table 4.17.1: Upper age limits for dosing of oral rotavirus vaccines
378
Table 4.19.1: Guide to tetanus prophylaxis in wound management
404
Table 4.22.1: Recommendations for varicella vaccination with (a) monovalent

varicella vaccine (VV) (currently available), and (b) once measlesmumps-rubella-varicella (MMRV) vaccines are available from
July 2013
428
Table 4.22.2: Zoster immunoglobulin-VF (ZIG) dose based on weight
436
Table A2.1: Electronic databases searched for the 10th edition
467
Table A3.1: Components of vaccines used in the National

Immunisation Program
469
Table A7.1: Key dates when vaccines first came into widespread
use in Australia
498
ix
LIST OF FIGURES
Figure 2.1.1: Catch-up worksheet for children <10 years of age for NIP
vaccines45
Figure 2.2.1: Positioning a child <12 months of age in the cuddle position
75
Figure 2.2.2: Positioning an infant on an examination table for vaccination
76
Figure 2.2.3: Positioning an older child in the cuddle position
77
Figure 2.2.4: Positioning a child in the straddle position
78
Figure 2.2.5: Anatomical markers used to identify the vastus lateralis

injection site (X) on the anterolateral thigh
79
Figure 2.2.6: The vastus lateralis injection site (X) on the anterolateral thigh
80
Figure 2.2.7: Anatomical markers used to identify the ventrogluteal

injection site (X)
81
Figure 2.2.8: Anatomical markers used to identify the deltoid injection site
82
Figure 2.2.9: A subcutaneous injection into the deltoid area of the upper
arm using a 25 gauge, 16 mm needle, inserted at a 45 angle
82
Figure 2.2.10: Recommended technique for giving multiple vaccine injections

into the anterolateral thigh in an infant <12 months of age
83
Figure 4.7.1: Influenza notification rates 20062007 and hospitalisation
rates 20052007, Australia, by age group
245
Figure 4.15.1: Q fever notifications for Australia, New South Wales and
Queensland, 1991 to 2009
346
Figure 4.16.1: Post-exposure prophylaxis algorithm for potential exposure

to classical rabies virus from a terrestrial animal overseas
366
Figure 4.16.2: Post-exposure prophylaxis algorithm for potential exposure

to lyssaviruses from bats in Australia or overseas
367
Figure 4.16.3: Booster algorithm for persons at ongoing risk of exposure

to either rabies or other lyssaviruses, including Australian
bat lyssavirus (ABLV)
369
Figure 4.17.1: Rotavirus-coded hospitalisations per month, Australia,

2001 to 2010
373
x The Australian Immunisation Handbook 10th edition (updated January 2014)
PREFACE
The 10th edition of The Australian Immunisation Handbook was prepared by
the Australian Technical Advisory Group on Immunisation of the Australian
Government Department of Health.
Members of the Australian Technical Advisory Group on

Immunisation
Chair
Professor Terry Nolan, Paediatrician; Epidemiologist and Head, School of
Population Health, The University of Melbourne, Victoria
Deputy Chair
Associate Professor Peter Richmond, School of Paediatrics and Child Health,
The University of Western Australia; General Paediatrician and Paediatric
Immunologist, Princess Margaret Hospital for Children, Western Australia
Voting and ex-officio members

Associate Professor Ross Andrews, Menzies School of Health Research,
Northern Territory
Associate Professor Christopher Blyth, School of Paediatrics and Child Health,
Faculty of Medicine, Dentistry and Health Sciences, The University of Western
Australia, Princess Margaret Hospital, Western Australia (member from July 2012)
Ms Sue Campbell-Lloyd, Manager, Immunisation Unit, AIDS/Infectious Diseases
Branch, NSW Health, New South Wales (member until June 2012)
Dr Grahame Dickson, Medical Officer, Drug Safety and Evaluation Branch,
Therapeutic Goods Administration, Australian Government Department of
Health, Australian Capital Territory (member until August 2012)
Dr Nicole Gilroy, Infectious Diseases consultant, St Vincents Hospital, Sydney;
Blood Marrow Transplant (BMT) Network, New South Wales
Ms Madeline Hall, Public Health Nurse, Queensland Health, Queensland
(member from July 2012)
Clinical Professor David Isaacs, Senior Staff Specialist, Department of Infectious
Diseases and Microbiology, The Childrens Hospital at Westmead and Paediatric
Infectious Diseases, The University of Sydney, New South Wales
Dr Rosemary Lester, Chief Health Officer, Department of Health, Victoria
(member until December 2011)
xi
Dr Ting Lu, Medical Officer, Office of Medicines Authorisation, Market

Authorisation Group, Therapeutic Goods Administration, Australian
Government Department of Health, Australian Capital Territory (member from
September 2012)
Professor Peter McIntyre, Professor of Paediatrics and Preventive Medicine,
The University of Sydney; Director, National Centre for Immunisation Research
and Surveillance of Vaccine Preventable Diseases, The Childrens Hospital at
Westmead, New South Wales
Associate Professor Jodie McVernon, School of Population Health, The University
of Melbourne, Victoria (member from January 2012)
Dr Joanne Molloy, General Practitioner, GP Association of Geelong, Victoria
Ms Stephanie Newell, Consumer representative (member until June 2012)
Associate Professor Michael Nissen, Director of Infectious Diseases and
Clinical Microbiologist, Unit Head of Queensland Paediatric Infectious Disease
Laboratory; Associate Professor in Biomolecular, Biomedical Science and Health,
Royal Childrens Hospital, Queensland (member until June 2012)
Dr Rod Pearce, General Practitioner, Medical Officer of Health, Eastern Health
Authority, Adelaide; GP Immunisation Advisor, Adelaide Central and Eastern
Division of General Practice, South Australia (member until June 2012)
Ms Karen Peterson, Immunisation Manager, Queensland Health, Queensland
(member from July 2012)
Ms Debra Petrys, Consumer representative (member from July 2012)
Ms Helen Pitcher, Public Health Nurse, Department of Human Services, Victoria
(member until June 2012)
Ms Julianne Quaine, Assistant Secretary, Health Protection Programs Branch,
Office of Health Protection, Australian Government Department of Health,
Dr Greg Rowles, General Practitioner, Riddells Creek, Victoria (member from
July 2012)
Dr Christine Selvey, Communicable Diseases Network Australia, Queensland
Health, Queensland (member from January 2012)
Professor Steven Wesselingh, Executive Director, South Australian Health and
Medical Research Institute, South Australia (member from July 2012)
Secretary
Ms Monica Johns, Director, Immunisation Policy Section, Immunisation Branch,
Office of Health Protection, Australian Government Department of Health,
xii The Australian Immunisation Handbook 10th edition (updated January 2014)
Secretariat support, Australian Technical Advisory Group on

Immunisation
Ms Sandy Anderson; Ms Jessica Hutchison
Senior technical editor

Associate Professor Kristine Macartney, Deputy Director Government Programs,
National Centre for Immunisation Research and Surveillance of Vaccine
Preventable Diseases, The Childrens Hospital at Westmead; Discipline of
Paediatrics and Child Health, The University of Sydney
Technical editor
Dr Jane Jelfs, Manager Policy Support, National Centre for Immunisation
Research and Surveillance of Vaccine Preventable Diseases
Assistant technical editor

Dr Melina Georgousakis, Research Officer, National Centre for Immunisation
Senior technical writer

Dr Clayton Chiu, Public Health Physician, National Centre for Immunisation
Technical writers
Mr Brett Archer; Ms Kathryn Cannings; Dr Bradley Christian; Dr Nigel
Crawford; Dr Aditi Dey; Dr Anita Heywood; Dr Sanjay Jayasinghe; Dr Robert
Menzies; Dr Helen Quinn; Dr Tom Snelling; Ms Kirsten Ward; Dr Nicholas Wood
Editorial support
Ms Donna Armstrong, Editing and Publications Officer, National Centre for
Immunisation Research and Surveillance of Vaccine Preventable Diseases
Library support
Ms Catherine King, Information Manager, National Centre for Immunisation
Mr Edward Jacyna, Assistant Librarian, National Centre for Immunisation
Administration support
Ms Lyn Benfield, Senior Administration Project Officer, National Centre for
Immunisation Research and Surveillance of Vaccine Preventable Diseases
xiii
Acknowledgments
Dr Frank Beard
Dr Vicki Krause
Professor Julie Bines
Associate Professor Stephen Lambert
Dr Julia Brotherton
Associate Professor Amanda Leach
Associate Professor Tony Brown
Professor Raina MacIntyre
Professor Margaret Burgess
Professor John Mackenzie
Dr Dave Burgner
Associate Professor Guy Marks
Dr Jim Buttery
Dr Jeremy McAnulty
Professor Jonathan Carapetis
Dr Brad McCall
Dr Ben Cowie
Dr Elizabeth McCarthy
Dr Andrew Daley
Dr Neil Parker
Professor Basil Donovan
Professor Bill Rawlinson
Dr Mark Douglas
Associate Professor Tilman Ruff
Professor David Durrheim
Dr Rosalie Schultz
Professor Dominic Dwyer
Dr Vicky Sheppeard
Professor Joan Faoagali
Associate Professor Vitali Sintchenko
Dr Tony Gherardin
Associate Professor Monica Slavin
Dr Heather Gidding
Associate Professor David Smith
Professor Lyn Gilbert
Dr Bruce Thorley
Dr Robert Hall
Dr Joe Torressi
Dr Alan Hampson
Dr Siranda Torvaldsen
Dr Penny Hutchinson
Ms Maureen Watson
Dr Heath Kelly
Dr Rosalind Webby
Professor Michael Kidd
Dr Melanie Wong
Dr Ann Koehler
Professor Nick Zwar
xiv The Australian Immunisation Handbook 10th edition (updated January 2014)
PART 1 INTRODUCTION TO THE AUSTRALIAN

IMMUNISATION HANDBOOK
For more than 200 years, since Edward Jenner first demonstrated that
vaccination offered protection against smallpox, the use of vaccines has
continued to reduce the burden of many infectious diseases. Vaccination has
been demonstrated to be one of the most effective and cost-effective public
health interventions. Worldwide, it has been estimated that immunisation
programs prevent approximately 2.5 million deaths each year.1 The global
eradication of smallpox in 1997, near elimination of poliomyelitis and global
reduction in other vaccine-preventable diseases, are model examples of disease
control through immunisation.
Vaccination not only protects individuals, but also protects others in the
community by increasing the overall level of immunity in the population
and thus minimising the spread of infection. This concept is known as herd
immunity. It is vital that healthcare professionals take every available
opportunity to vaccinate children and adults. Australia has one of the most
comprehensive publicly funded immunisation programs in the world. As a result
of successful vaccination programs in Australia, many diseases, for example,
tetanus, diphtheria, Haemophilus influenzae type b and poliomyelitis, do not occur
now or are extremely rare in Australia.2
The purpose of The Australian Immunisation Handbook is to provide clinical
guidelines for health professionals on the safest and most effective use of vaccines
in their practice. These recommendations are developed by the Australian
Technical Advisory Group on Immunisation (ATAGI) and were considered
for approval by the National Health and Medical Research Council (NHMRC)
(under section 14A of the NHMRC Act 1992).
The Handbook provides guidance based on the best scientific evidence available
at the time of publication from published and unpublished literature. Further
details regarding the Handbook revision procedures are described below in 1.2
Development of the 10th edition of the Handbook. The reference lists for all chapters
are included in the electronic version of the Handbook, which is available via the
Immunise Australia website (www.immunise.health.gov.au).
The information contained within this Handbook was correct as at October 2012.
However, the content of the Handbook is reviewed regularly. The 10th edition
of The Australian Immunisation Handbook will remain current unless amended
electronically via the Immunise Australia website or until the 11th edition of the
Handbook is published.
PART 1 INTRODUCTION TO THE AUSTRALIAN IMMUNISATION HANDBOOK 1
1.1 BACKGROUND
1.1 BACKGROUND
Information is provided in the Handbook for all vaccines that are available in
Australia at or near the time of publication. These include many vaccines that are
funded under the National Immunisation Program (NIP). A copy of the current
NIP schedule is provided with the hard copy of the Handbook. However, the
NIP schedule may also be updated regularly; immunisation service providers
should consult the Immunise Australia website (www.immunise.health.gov.
au) for changes. A number of vaccines included in this Handbook are not part
of the routine immunisation schedule; these vaccines may be given to, for
example, persons travelling overseas, persons with a medical condition placing
them at increased risk of contracting a vaccine-preventable disease, or those at
occupational risk of disease.
Electronic updates to the 10th edition of

The Australian Immunisation Handbook will be available at:
References
A full reference list is available on the electronic Handbook or website
2 The Australian Immunisation Handbook 10th edition (updated January 2014)
It is important to note that recommendations contained within the Handbook

do not formally address the cost-effectiveness of different vaccines or different
vaccine schedules. Since January 2006, the cost-effectiveness of vaccines
is assessed by the Pharmaceutical Benefits Advisory Committee (PBAC),
which advises government on the funding of vaccines under the National
Immunisation Program and/or Pharmaceutical Benefits Scheme (PBS). Most,
but not all, of the recommendations made within the Handbook will be funded
under the NIP, PBS or via other means, such as through special schemes and
state- or territory-based programs.
1.2.1 Process of developing Handbook recommendations

The Handbook is designed as a general guide to inform clinicians on the safest and
most effective vaccination strategies, using the highest quality evidence available.
In the absence of high-quality evidence, such as well-conducted randomised
controlled trials and meta-analyses, the ATAGI based its recommendations on
less rigorous studies, such as uncontrolled clinical trials, case-series and/or other
observational studies. Where clinical guidelines were available on specific topics,
these were also consulted to help frame recommendations, if relevant, in the
Australian setting. Further details on literature search strategies utilised for the
production of this edition can be found in Appendix 2. The ATAGI also consulted
immunisation handbooks produced by comparable countries. When published
sources were inadequate, recommendations were based on expert opinion.
However, limitations and challenges to developing recommendations continue to
exist when there are unaddressed scientific questions, complex medical practice
issues and continuous new information, as well as differences in expert opinion.
Despite these limitations, the ATAGI has sought to provide clear and relevant
recommendations wherever possible.
The 1st edition of The Australian Immunisation Handbook was published in 1975.
Due to its longevity, scope and complexity, the Handbook does differ from other
NHMRC guidelines. As such, recommendations contained in the Handbook do
not contain formal levels or grades of evidence or evidence tables. The grades of
evidence assigned to recommendations for the three newly vaccine-preventable
diseases (human papillomavirus [HPV], rotavirus and herpes zoster) that were
included in the 9th edition Handbook (and its electronic amendments) have now
EDITION OF THE HANDBOOK
The 10th edition of the Handbook has been developed by the Australian Technical
Advisory Group on Immunisation (ATAGI), which provides advice to the Federal
Minister for Health on the Immunise Australia Program and other vaccinerelated issues. In addition to technical experts from many fields, the ATAGIs
membership includes a consumer representative and general practitioners. Staff
of the National Centre for Immunisation Research and Surveillance of Vaccine
Preventable Diseases (NCIRS) provided the technical support to the ATAGI to
develop the Handbook.
1.2
THE
10TH
12
.DEVDEVELOPMENT
ELOPMENTOT
FHE
10THEDITIOOF
NOT
FH
EHAND
BOOK
1.2 DEVELOPMENT OF THE 10TH EDITION OF THE HANDBOOK
been removed and replaced with an evidence statement for consistency with
other chapters in the 10th edition of the Handbook. The ATAGI has developed new
recommendations for the Handbook after considering clinical questions, reviewing
available evidence, as described above, and through extensive consultation with
other experts (described below). Evidence statements for recommendations, with
cross reference to other relevant sections of the Handbook, have been included
wherever possible.
1.2.2 Consultation and input into the draft 10th edition Handbook
Prior to completion of the draft 10th edition Handbook, the ATAGI sought expert
review of individual chapters by leading Australian experts. These reviewers,
who are acknowledged in the front of this Handbook, provided input to further
refine each chapter. The ATAGI also, where relevant, consulted members of
each of its current disease-based Working Parties. Other peak advisory groups,
in particular the National Immunisation Committee, were also consulted and
provided valuable input into the development of this revised edition. The draft
10th edition of the Handbook was available for public consultation over a 4-week
period during JulyAugust 2012. The ATAGI reviewed all public comments
received and, where necessary, incorporated these as changes to the Handbook.
The NHMRC was also consulted throughout the development of the 10th
edition of the Handbook, prior to the Handbook being proposed for submission to
the NHMRC for consideration of approval (under section 14A of the NHMRC
Act 1992).
1.2.3 Implementation of recommendations in the 10th edition

Handbook
The 10th edition of the Handbook is disseminated directly to all registered
medical practitioners in Australia. Additional hard copies are distributed to
other immunisation service providers via their state or territory health
authority. An electronic version of the Handbook is freely accessible on the
Immunise Australia Program website (www.immunise.health.gov.au).
Implementation of the recommendations as stated in the Handbook is undertaken
by immunisation service providers in conjunction with their state or territory
health authority and the Immunise Australia Program of the Australian
Government Department of Health.
1.3 HOW TO USE THE 10TH EDITION HANDBOOK
Part 4 of the Handbook contains 24 chapters, each dealing with an individual

disease for which a vaccine, or vaccines, are currently available in Australia.
These chapters all follow the same format and are divided into various sections
describing:
the biology, clinical features and epidemiology of the disease
information on vaccines, with those available, or soon to be available, in
Australia highlighted in a shaded box (for more information see also the
Therapeutic Goods Administration, www.tga.gov.au, for the latest vaccine
product information document provided by the manufacturer and
1.5.3 Active immunisation)
recommendations for vaccine use
use in pregnancy and breastfeeding
contraindications, precautions and advice on adverse events following
immunisation specific to the vaccine(s) (for more information see
1.5.5 Vaccine safety and adverse events following immunisation)
information on the public health management of each disease; this is
only given in detail where there are specific additional recommendations
for vaccine use in the context of disease control and/or post-exposure
prophylaxis
variations from product information.
1.3 HOW TO USE THE
The Handbook is divided into five major parts. Part 1 contains information on
the development process for the Handbook, a summary of changes from the 9th
edition Handbook, and an overview of the general principles of immunisation,
including both active and passive immunisation, vaccine efficacy and vaccine
safety. Part 2 of the Handbook is divided into three chapters, which describe
the processes and procedures involved around a vaccination encounter: prevaccination requirements; a detailed discussion of the administration of vaccines;
and information on post-vaccination considerations. In Part 3 of the Handbook,
there are three chapters, each dedicated to vaccinations for different special risk
groups, including Aboriginal and Torres Strait Islander people, international
travellers, and other special risk categories (e.g. immunocompromised persons,
pregnant women and others).
10TH EDITION HANDBOOK
The following information provides an overview of how information is presented

in this 10th edition of The Australian Immunisation Handbook, to guide the reader
in how to best use this resource.
Variations from product information

In some instances, the ATAGI recommendations in the Handbook
may differ from information provided by the manufacturer in the
vaccine product information document (PI); these differences may be
recommendations that are in addition to or instead of those listed in the
PI. Where indicated, variations from the PI are detailed in each relevant
vaccine chapter under the heading Variations from product information.
Where a variation exists, the ATAGI recommendation should be
considered best practice.
The reader is encouraged to seek additional information on communicable

disease surveillance, prevention and control, including published guidelines,
from the Communicable Diseases Network Australia (CDNA) via the Australian
Government CDNA website (www.health.gov.au/cdnasongs).
Part 5 of the Handbook pertains to passive immunisation using immunoglobulin
preparations and provides an overview of the available products and their
intended use.
There are a number of appendices, including contact details for state and
territory health departments (Appendix 1); the literature search strategies
used for the 10th edition of the Handbook (Appendix 2); components used in
the vaccines available via the National Immunisation Program (Appendix 3);
some commonly asked questions (Appendix 4); a glossary of terms used in the
Handbook (Appendix 5); abbreviations used in the Handbook (Appendix 6); and a
list of dates when various vaccines became available in Australia (Appendix 7).
1.4 WHATS NEW
1.4.1 New chapters and chapters that no longer appear in

the Handbook
Layout of the Handbook differs from the previous edition. The Handbook
is now in 5 parts: Part 1 Introduction to The Australian Immunisation
Handbook; Part 2 Vaccination procedures; Part 3 Vaccination for special risk
groups; Part 4 Vaccine-preventable diseases; and Part 5 Passive immunisation.
Part 1 now includes the development process for the Handbook
(previously in Appendix 2) and information on the fundamentals of
immunisation, including passive and active immunisation, vaccine
efficacy and vaccine safety.
The new Part 5 Passive immunisation contains information previously
contained in Chapter 3.8 of the 9th edition, Immunoglobulin preparations.
The chapter on Australian bat lyssavirus and rabies is now listed under Rabies
and other lyssaviruses (including Australian bat lyssavirus) in the alphabetical list
of diseases in Part 4.
The chapter on zoster (herpes zoster) is now included as a disease chapter
in Part 4 in this printed version of the 10th edition. It had previously been
available as an online update to the 9th edition.
The chapter on smallpox has been deleted. For information on smallpox, see
the Guidelines for smallpox outbreak, preparedness, response and management on
the Department of Health website www.health.gov.au.
Some appendices contained in the 9th edition have been deleted:
Products registered in Australia but not currently available (previously
Appendix 3); information regarding such products can be sought from
the Therapeutic Goods Administration (www.tga.gov.au)
Definitions of adverse events following immunisation (previously Appendix 6);
some common adverse events are now defined in the glossary of technical
terms and an expanded section on adverse events following immunisation
is now provided in Part 2 (2.3.2)
Summary table procedures for a vaccination encounter (previously Appendix 10);
this information is now incorporated throughout Part 2.
1.4.2 Changes to the format of disease chapters in Part 4

Where relevant, information on reconstitution and stability of reconstituted
vaccines has been included in the Transport, storage and handling section of
disease chapters.
1.4 what's new
All chapters have been updated and revised, where necessary, from the 9th
edition. The 10th edition introduces new vaccines, changes to the schedules and
recommendations, and changes to the presentation of the Handbook.
Where relevant, information on co-administration with other vaccines

and interchangeability of vaccines is now included in the Dosage and
administration section of disease chapters.
A Pregnancy and breastfeeding section has been added to all disease
chapters.
Information on the public health management of each disease is only given
in detail where there are specific additional recommendations for vaccine
use in the context of disease control and/or post-exposure prophylaxis.
The reader is referred to published guidelines from the Communicable
Diseases Network Australia (CDNA), where available.
The Evidence Grades assigned in the 9th edition to recommendations
contained within three chapters Human papillomavirus, Rotavirus and Zoster
(online only) have been removed (see discussion in 1.2 Development of the
10th edition of the Handbook regarding Handbook development).
1.4.3 Overview of major changes to recommendations

The following list summarises major changes to recommendations and other
important information that have occurred in each part of the 10th edition of
the Handbook.
Part 2 Vaccination procedures

2.1 Pre-vaccination
The checklist summarising activities required for optimal storage of vaccines

has been deleted; readers are referred to the National vaccine storage guidelines:
Strive for 5.
The table (Table 2.1.5) containing information on the minimum acceptable
age for the 1st vaccine doses in infants now provides advice on action
required in case of early administration.
Catch-up recommendations and tables are now for children aged <10 years
(previously <8 years).
Catch-up guidelines have been included for new vaccines (MMRV, HibMenCCV, 13vPCV and 10vPCV).
Updated pneumococcal catch-up tables (Tables 2.1.9, 2.1.10 and 2.1.11)
provide recommendations for use of pneumococcal vaccines up to the
age of 5 years.
Information is provided on the HALO (health, age, lifestyle, occupation)
principle for use when considering catch-up vaccination for adults.
Additional vaccines (MenCCV, 13vPCV, 23vPPV, zoster) have been added to
the catch-up table (Table 2.1.12) for adolescents and adults and this table now
applies to persons 10 years of age (previously 8 years).
2.2 Administration of vaccines
Advice is now provided on the use of vaccines in multi-dose vials.
Information is now provided on vaccinating children with congenital limb

malformation, children in spica casts, patients undergoing treatment for
breast cancer, and patients with lymphoedema.
The section on administration of multiple vaccine injections at the same visit
now includes advice on the order in which to give sequential vaccines and
advice on simultaneous injections by two providers.
2.3 Post-vaccination
The section on adverse events following immunisation has been enhanced

and expanded, including use of adrenaline autoinjectors for anaphylaxis
treatment and more information on reporting of adverse events following
immunisation.
Contact details are provided for obtaining HPV vaccination history from
the National HPV Vaccination Program Register (NHVPR, or the HPV
Register).
The section on documentation of vaccination has been expanded to include
updated details for reporting to the ACIR, and information on the National
HPV Vaccination Program Register and other registers.
Part 3 Vaccination for special risk groups

3.1 Vaccination for Aboriginal and Torres Strait Islander people
Information on the burden of influenza in Indigenous children, and the

rationale for vaccination of those, especially 6 months to <5 years of age,
has been included.
It is now recommended that Aboriginal and Torres Strait Islander people
have their risks and vaccination status for hepatitis B reviewed, be offered
testing for previous hepatitis B infection, and be offered vaccination if
non-immune.
Information on the importance of ensuring immunity to rubella,
especially among rural and remote Indigenous women of child-bearing
age, has been added.
A new table (Table 3.1.1) has been added summarising additional vaccines
recommended for Aboriginal and Torres Strait Islander people.
1.4 what's new
Advice is provided on what to do if a vaccine is inadvertently administered

via a route (e.g. intramuscular [IM] or subcutaneous [SC]) other than for
which it is recommended.
3.2 Vaccination for international travel
This section has been updated and expanded and information on

recommended vaccines is now divided into routinely recommended vaccines
(that are not specifically related to travelling overseas) and selected vaccines
that are recommended based on travel itinerary, activities and likely risk of
disease exposure.
Information on more vaccines, including new vaccines, has been added to
the tables outlining the dose and routes of administration (Table 3.2.1) and
recommended lower age limits (Table 3.2.2) for vaccines for travellers.
3.3 Groups with special vaccination requirements
The section on vaccination of persons with a prior adverse event following

immunisation has been expanded. Advice is provided on vaccination of
persons with allergies, including egg allergy.
The section on vaccination of women who are planning pregnancy, pregnant
or breastfeeding, and preterm infants has been updated and expanded.
The table of recommendations for vaccination in pregnancy (Table 3.3.1) has
been updated to include new vaccines.
dTpa vaccine can be given during the third trimester of pregnancy as an
alternative to post-partum or pre-conception vaccination.
The section on vaccination of immunocompromised persons, including
transplant recipients and oncology patients, has been updated and expanded.
All immunocompromised persons, irrespective of age, who receive influenza
vaccine for the first time are now recommended to receive 2 vaccine doses, at
least 4 weeks apart, and 1 dose annually thereafter.
The tables of recommendations for vaccinations in solid organ transplant
(Table 3.3.2) and haematopoietic stem cell transplant (Table 3.3.3) recipients
have been updated to include new vaccines.
Information on recommendations for persons infected with human
immunodeficiency virus (HIV) now discusses both children and adults and
includes rotavirus, HPV, varicella and zoster vaccines.
The section on vaccination of persons with functional and anatomical
asplenia has been updated to include new vaccines, and now includes a table
(Table 3.3.5) summarising vaccine recommendations in this group.
The section on vaccination of persons with autoimmune diseases has been
expanded to include those undergoing treatment with immunosuppressive
agents and those with Guillain-Barr syndrome and other chronic conditions
(hypopituitarism and metabolic diseases).
The section on vaccination of recent recipients of normal human
immunoglobulin and other blood products has been expanded.
The section on vaccination of persons with bleeding disorders has been

updated to include new recommendations for when IM injections should be
deferred and advice regarding vaccination of persons with haemophilia.
The section on vaccination of migrants to Australia has been expanded.

A new section has been added to provide recommendations for vaccination
for sex industry workers.
Part 4 Vaccine-preventable diseases

4.1 Cholera
If the interval between primary immunisation and booster dose is more

than 6 months in children aged 26 years, or more than 2 years in adults and
children aged >6 years, primary immunisation must be repeated.
4.2 Diphtheria, 4.19 Tetanus and 4.12 Pertussis
The 1st dose of DTPa-containing vaccines due at 2 months of age can be

given as early as 6 weeks of age.
Advice is provided that an additional dose of pertussis-containing vaccine
can be given in the 2nd year of life (e.g. at 18 months of age) if parents wish
to minimise the likelihood of their child developing pertussis.
The booster dose of DTPa-containing vaccine recommended at 4 years of age
can be given as early as 3.5 years.
DTPa-containing vaccines can be used for primary or booster doses in
children aged <10 years (previously 8 years). Unvaccinated or partially
vaccinated contacts of pertussis cases should be offered DTPa-containing
vaccines up to their 10th birthday (previously 8th); dTpa should be offered to
those aged 10 years.
The 2nd booster dose recommended for adolescents (using dTpa) should
preferably be given between 11 and 13 years of age.
Adults aged 65 years should be offered a single dTpa booster if they have
not received one in the previous 10 years.
For adults who are in certain risk categories for acquiring pertussis,
or transmitting it to vulnerable persons, revaccination with dTpa is
recommended 10 years after receipt of a prior pertussis-containing vaccine.
This interval can be shortened to 5 years in the context of pregnancy.
Information is provided on maternal vaccination with dTpa during the third
trimester of pregnancy as an alternative to post-partum or pre-conception
vaccination.
1.4 what's new
The table of recommended vaccinations for persons at risk of occupationally

acquired vaccine-preventable diseases (Table 3.3.7) has been updated to
include new occupational groups and recommendations.
For persons undertaking high-risk travel, a 5-yearly booster dose with dT or

dTpa should be considered for protection against tetanus. In other travellers,
a booster dose of tetanus-containing vaccine should be provided if 10 years
have elapsed since the previous dose.
More information on the definition of tetanus-prone wounds is provided,
and the table (Table 4.19.1) on wound management has been updated to
include recommendations for use of tetanus immunoglobulin (TIG) in
immunocompromised persons.
Information on diphtheria antitoxin is now contained in Part 5 of
the Handbook.
4.3 Haemophilus influenzae type b
Combination Hib-meningococcal C vaccine (Hib-MenCCV) included.

Hib vaccination recommendations apply to all children, including Aboriginal
and Torres Strait Islander children, as only PRP-T Hib vaccines have been in
use in recent years.
4.4 Hepatitis A
The section on serological testing for hepatitis A prior to vaccination has

been expanded, and more detail provided as to rationale for vaccination of
certain groups.
Hepatitis A vaccination is recommended in preference to NHIG for use in
post-exposure prophylaxis in immunocompetent persons 12 months of age.
4.5 Hepatitis B
Different schedules for hepatitis B vaccination, including minimum intervals

between doses, have been described in more detail.
Advice is provided regarding the validity of a hepatitis B vaccine schedule
used for children born overseas, who were vaccinated at birth, 1 month and
6 months of age.
Information is provided on checking for infection/immunity to hepatitis B
in infants born to mothers with chronic hepatitis B infection 3 to 12 months
after the primary vaccine course.
It is now recommended that Aboriginal and Torres Strait Islander people
have their risks and vaccination status for hepatitis B reviewed, be offered
testing for previous hepatitis B infection, and be offered vaccination if
non-immune.
Migrants from hepatitis B endemic countries should be offered testing for
hepatitis B, and vaccination if appropriate.
The section on serological testing for hepatitis B prior to vaccination has
been expanded, and more detail provided as to rationale for testing and/or
vaccination of certain groups, including hepatitis B vaccine non-responders.
4.6 Human papillomavirus
HPV vaccination is now not routinely recommended for women aged

1926 years. A risk-benefit assessment should be conducted when
contemplating vaccination of women in this and older age groups.
Recommendations for use of HPV in males have been included. HPV
vaccination is recommended for males aged 918 years, with the optimal
age for vaccination being 1113 years.
Specific recommendations regarding the use of HPV vaccine in
immunocompromised persons and men who have sex with men are
now included.
4.7 Influenza
Intradermal influenza vaccines are included.

Ages for which different brands of influenza vaccine are registered have been
specified.
Readers are referred to the Immunise Australia website (www.immunise.
health.gov.au) to check annual statements on influenza vaccine availability
and recommendations for use.
Information on the disease burden and benefits of influenza vaccination in
pregnancy and in children aged 6 months and <5 years has been expanded.
The list of persons at increased risk of complications from influenza infection
has been expanded to include persons with significant obesity and persons
with Down syndrome. Alcoholism has been added to the list of chronic
illnesses increasing the risk of complications from influenza infection.
Immunocompromised persons, irrespective of age, who receive influenza
vaccine for the first time are now recommended to receive 2 vaccine doses, at
least 4 weeks apart, and 1 dose annually thereafter.
Influenza vaccination is now also recommended for staff working in early
childhood education and care and for persons working in the pork industry.
4.8 Japanese encephalitis
Two new JE vaccines are included.

Advice on booster doses and information on adverse events have been
updated.
4.9 Measles, 4.11 Mumps, 4.18 Rubella and 4.22 Varicella
Recommendations for MMRV vaccines are updated, and changed from

the recommendations provided in the 9th edition. It is stated that MMRV
vaccines will be available in Australia from July 2013.
1.4 what's new
HPV vaccination is now recommended for girls at the optimal age for
vaccination of 1113 years.
MMR vaccine is to be used for the 1st dose at 12 months of age. MMRV is not
recommended for use as the 1st dose of MMR-containing vaccine in children
<4 years of age.
The recommended age for administration of the 2nd dose of measlescontaining vaccine will be moved from 4 years of age to 18 months of age
(from July 2013).
MMRV vaccine can be used as the 2nd dose of MMR-containing vaccine
and to provide a single dose of varicella vaccine at 18 months of age (from
July 2013).
MMRV vaccines are not recommended in persons 14 years of age.
A new table has been included in the Measles (Table 4.9.1) and Varicella (Table
4.22.1) chapters summarising the different recommendations before and after
the introduction of MMRV vaccines in July 2013.
The table describing post-exposure prophylaxis for measles (Table
4.9.2) has been revised and expanded to include more specific age
ranges, MMR vaccination history and advice regarding persons who are
immunocompromised.
More information on serological testing and revaccination of women of childbearing age who are non-immune to rubella is included.
4.10 Meningococcal disease
Combination Hib-meningococcal C vaccine (Hib-MenCCV) has been

included.
Quadrivalent meningococcal conjugate vaccines (4vMenCV) have been
included.
4vMenCV is preferred over the quadrivalent meningococcal polysaccharide
vaccine (4vMenPV) for use in persons aged 9 months who are at increased
risk of meningococcal disease.
For young children with medical risk factors for meningococcal disease,
meningococcal C conjugate vaccine (MenCCV) is recommended in those
aged 6 weeks to <12 months; thereafter 4vMenCV is recommended in a
2-dose schedule at approximately 12 and 18 months of age.
5-yearly booster doses of 4vMenCV are recommended for persons at ongoing
high risk of meningococcal infection.
For persons at ongoing risk of meningococcal infection who have previously
received 4vMenPV, a booster dose of 4vMenCV should be given 3 years after
the 4vMenPV and then every 5 years.
4.13 Pneumococcal disease
10-valent (10vPCV) and 13-valent (13vPCV) pneumococcal conjugate

vaccines are included.
The list of conditions associated with increased risks of invasive

pneumococcal disease (IPD) (List 4.13.1) has been revised to include both
adults and children, and is now divided into two categories: those conditions
posing the highest increased risk of developing IPD and those associated with
an increased risk of IPD.
The table (Table 4.13.3) summarising recommendations for vaccination of
adults with 23vPPV has been revised.
Recommendations for the use of a single dose of 13vPCV in adults and
children >5 years of age with conditions associated with the highest increased
risk of IPD (and who have not previously received a 13vPCV dose) are
included.
Information on the use of 23vPPV in persons >5 years of age at increased risk
of IPD has also been more clearly presented.
4.14 Poliomyelitis
The 1st dose of IPV-containing combination vaccine due at 2 months of age

can be given as early as 6 weeks of age.
A booster dose of IPV-containing vaccine is recommended at 4 years of age,
but can be given as early as 3.5 years.
4.15 Q fever
Q fever vaccination and skin testing training is now undertaken via an

educational module available online.
Information on the Australian Q Fever Register, which lists Q fever
immunisation service providers and records of Q fever vaccinations given to
some persons, is included.
Q fever vaccination is now also recommended for professional dog and
cat breeders, and wildlife and zoo workers who have contact with at-risk
animals, including kangaroos and bandicoots.
4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)
The terms PEP (post-exposure prophylaxis) and PreP (pre-exposure

prophylaxis) are used throughout the chapter.
Information and recommendations on management of all potential lyssavirus
exposures, including lyssavirus infection from exposure to bats in non-rabiesenzootic countries, is now included.
A 4-dose PEP schedule is now recommended for immunocompetent
persons. A 5-dose schedule is only recommended for persons who are
immunocompromised.
1.4 what's new
For Aboriginal and Torres Strait Islander children living in the Northern
Territory, Queensland, South Australia or Western Australia, a booster dose of
13vPCV at 1218 months of age replaces the booster dose of 23vPPV at 1824
months of age.
A table (Table 4.16.1) summarising World Health Organization (WHO)

categories of lyssavirus exposure, for guidance in use of post-exposure
prophylaxis, has been added.
Algorithms are provided with details of the recommended management
pathways for post-exposure prophylaxis for rabies and other lyssaviruses
(including Australian bat lyssavirus), and for booster doses for persons at
ongoing risk of exposure to rabies and other lyssaviruses.
Advice regarding the completion of post-exposure prophylaxis commenced
overseas has been expanded, including the addition of a summary table
(Table 4.16.2).
Persons who have completed a primary course of a currently available cell
culture-derived rabies vaccine no longer routinely require booster doses if
travelling or living in an area of high risk.
Information on the role of serological testing has been more clearly presented.
4.17 Rotavirus
The upper age limits for each dose of rotavirus vaccines are more clearly
defined.
Contraindications to rotavirus vaccination now include previous history of
intussusception (IS) and severe combined immunodeficiency in infants.
Information on the safety of rotavirus vaccines in infants with underlying
conditions and infants who are immunocompromised has been updated.
Information on adverse events following rotavirus vaccination has been
updated and expanded, including new information on the low, but increased,
risk of IS occurring following the 1st or 2nd dose of either rotavirus vaccine.
4.20 Tuberculosis
Bacille Calmette-Gurin (BCG) vaccination is no longer routinely

recommended for neonates weighing <2.5kg.
Generalised septic skin disease, skin conditions such as eczema, dermatitis
and psoriasis, and significant febrile illness are no longer contraindications to
BCG vaccination but, if present, vaccination should be deferred.
4.23 Yellow fever
Yellow fever vaccine is not recommended in women who are breastfeeding

infants aged <9 months.
More detail is provided on how to access the WHO information regarding
areas of high yellow fever activity and requirements for travel.
4.24 Zoster
Information on the efficacy of vaccination in persons aged 5059 years has

been included.
Part 5 Passive immunisation
1.4 what's new
Information regarding the use of intravenous immunoglobulins as treatment

for disease conditions (such as Kawasaki disease) or as replacement therapy
for immunodeficient individuals is no longer included in the Handbook.
Readers are referred to National Blood Authority guidelines.
1.5 FUNDAMENTALS OF IMMUNISATION

1.5.1 Overview
Vaccines are complex biological products designed to induce a protective
immune response effectively and safely. Vaccines contain one or more antigens
(or immunogens) that stimulate an active immune response. These are generally
protein- or polysaccharide (sugar)-based substances. The number and derivation
of the antigen(s) contained in each vaccine vary. Most vaccines work by inducing
B-lymphocytes to produce antibodies that bind to and inhibit pathogenic
organisms or their toxins. Generation of T-cell-mediated (cellular) immunity is
also important for some vaccines.
Vaccines, like all medicines, are regulated in Australia by the Therapeutic Goods
Administration (TGA). Before they are made available for use they are rigorously
tested in human clinical trials to confirm that they are safe and that they
stimulate protective immune responses. Vaccines are also evaluated to ensure
compliance with strict manufacturing and production standards. This testing is
required by law and is usually conducted both during the vaccines development
and after its registration. In addition, once they are in use, the safety of vaccines
is monitored by the TGA and other organisations using different methods,
including passive and active surveillance for adverse events following
immunisation (see 1.5.5 Vaccine safety and adverse events following immunisation).
1.5.2 Passive immunisation

Passive immunity is the direct transfer or administration of antibodies to a
non-immune person to provide immediate protection. One example of passive
immunisation is the transfer of maternal antibodies to the fetus, which provides
some short-lived protection of the newborn infant against certain infections.1,2
Another example is the administration of a product containing antibodies
(or immunoglobulins, IgG) pooled from blood donors, in order to provide
temporary protection to a non-immune person who has recently been exposed to
infection.3 The protection afforded is immediate, but lasts for only a few weeks
as the half-life of IgG is approximately 3 to 4 weeks. Regular immunoglobulin
infusions are also indicated for some immunocompromised persons who are
deficient in antibody. A separate use of immunoglobulins is in the treatment
of a number of specific immune-mediated conditions in order to modulate
the disease course. For further information regarding the use of intravenous
immunoglobulin for this purpose, refer to Criteria for the clinical use of intravenous
immunoglobulin in Australia (www.nba.gov.au/ivig/index.html).
For more information on passive immunisation see Part 5 Passive immunisation.
1.5.3 Active immunisation

Active immunisation involves the use of vaccines to stimulate the immune
system to produce a protective immune response. Vaccines usually induce
an immune response that mimics the hosts response to natural infection, but
Adjuvants, which enhance the immune response to an antigen; an example is

aluminium hydroxide.
Preservatives, which reduce the risk of contamination; some examples
are 2-phenoxyethanol, which is also used in many cosmetics and
pharmaceuticals, and thiomersal, which is used in the Q fever vaccine but is
not present in any of the vaccines on the National Immunisation Program for
young children.
Stabilisers, which improve the shelf-life and help to protect the vaccine from
adverse conditions; examples are sucrose, mannitol, lactose and gelatin.
Stabilisers are also used in most confectionery and many pharmaceuticals.
Emulsifiers or surfactants, which alter the surface tension of the liquid
vaccine; examples are polysorbate-80 and sorbitol. Emulsifiers are added to
most ice creams and many pharmaceuticals.
Residuals, which are minute or trace amounts of substances that remain after
the manufacture of the vaccine; examples of residuals detectable in some
vaccines are formaldehyde, antibiotics such as neomycin or polymyxin, and
egg proteins.
Further details of a particular vaccines constituents can be found in either the
product information (PI) or the consumer medicines information (CMI) for
individual vaccines. This information is presented in the shaded box for each
vaccine under the disease-specific chapters in Part 4 of this Handbook (current
June 2012); however, it is important to note that PIs and CMIs are updated
periodically. The most current versions of the PI (and CMI) for vaccines (and
other medicines) are available from the TGA website (www.tga.gov.au).
In addition, information on the components contained in vaccines that are
available under the Australian National Immunisation Program is provided in
Appendix 3 of this Handbook, and further details on vaccine composition can be
found in Appendix 4 Commonly asked questions about vaccination.
OF IMMUNISATION
In addition to containing the immunising antigen(s), vaccines may also contain

the following:
1.5 FUNDAMENTALS
without the harmful consequences of the infection itself. In addition to antibody

responses, many vaccines also stimulate cell-mediated immunity. Immunity
following active immunisation generally lasts for months to many years,
depending on the nature of the vaccine as well as host factors.4,5 Protective
immunity is induced by antigen(s) contained within the vaccine. This may be a
toxoid (a bacterial toxin that has been rendered non-toxigenic, e.g. for tetanus or
diphtheria); killed or inactivated bacteria or viruses, such as hepatitis A vaccines;
live attenuated bacteria or viruses, such as measles, mumps and rubella vaccines;
or subunit components of a pathogen that only contain the antigen(s) of interest,
such as the hepatitis B vaccine.4,5
The recommended number of doses and age of administration vary for each
vaccine. These recommendations are based on the type of vaccine, disease
epidemiology (the age-specific risk for infection and for complications), and the
anticipated immune response of the recipient (including whether transplacental
transfer of maternal antibodies will inhibit the immune response in an infant).4,5
Several doses of a vaccine may be required to induce protective immunity,
particularly in younger children.
Homeopathic preparations do not induce immunity and are never an alternative
to vaccination (see Appendix 4 Commonly asked questions about vaccination).
Detailed information on the background, available vaccines and
recommendations for vaccines used in active immunisation are provided in the
disease-specific chapters in Part 4 of this Handbook.
1.5.4 Vaccine efficacy, vaccine effectiveness and vaccine failure

The terms vaccine efficacy and vaccine effectiveness are often used
interchangeably. However, in general terms, vaccine efficacy refers to estimates of
protection obtained under the idealised conditions of a randomised controlled
trial (RCT). It is usually expressed as the percentage reduction in a persons
risk of disease if vaccinated compared to the risk if not vaccinated. Vaccine
effectiveness refers to estimates of protection obtained under real world rather
than trial conditions, for example, in immunisation programs after vaccine
registration. Sometimes vaccine effectiveness is also taken to include the
broader impact of a vaccination program on overall disease incidence in the
population, including any additional herd protection conferred to unvaccinated
individuals.4,6
The extent and duration of protection provided by vaccination varies and
is influenced by many factors. For example, some vaccines, such as the
pneumococcal and meningococcal polysaccharide vaccines, provide protection
for a few years only. This is because polysaccharide antigens induce antibodies
without the involvement of T-lymphocytes (T-cell independent response). T-cell
lymphocyte involvement is needed for long-term immune memory; without it,
protection is relatively short-lived and immunity wanes, sometimes requiring
revaccination. In addition, polysaccharide vaccines are less immunogenic
in children aged <2 years.4 The process of conjugating (or linking) capsular
polysaccharides to a protein carrier creates conjugate vaccines that can induce
antibody production with the help of T-lymphocytes (T-cell dependent response).
This results in higher-quality and longer-term immunity, including in children
<2 years of age.4 Conjugated vaccines are available for Haemophilus influenzae
type b, Neisseria meningitidis (serogroups A, C, W135 and Y) and pneumococcal
disease.
Vaccination failure can be due to either vaccine failure or failure to vaccinate (i.e.
that an indicated vaccine was not administered appropriately for any reason).
Sometimes a vaccinated person may develop infections despite being vaccinated
What is an adverse event following immunisation?

The term adverse event following immunisation (AEFI) refers to any
untoward medical occurrence that follows immunisation, whether
expected or unexpected, and whether triggered by the vaccine or only
coincidentally occurring after receipt of a vaccine. The adverse event may
be any unfavourable or unintended sign, abnormal laboratory finding,
symptom or disease.7
Adverse events following immunisation (AEFI) should be reported

promptly, either according to relevant state or territory protocols or directly
to the TGA (for detailed information on reporting and management of AEFI,
see 2.3 Post-vaccination).
The safety of vaccines is very important as vaccines are given to prevent disease
and target all or many members of the population, most of whom are healthy.
All vaccines available in Australia must pass stringent safety testing before being
approved for use by the TGA. This testing is required by law and is usually
done over many years during the vaccines development. In addition, the TGA
monitors the safety of vaccines once they are registered.
From the time a vaccine comes into use, there is ongoing review of both vaccine
safety and efficacy through a variety of mechanisms, such as further clinical
OF IMMUNISATION
1.5.5 Vaccine safety and adverse events following immunisation
1.5 FUNDAMENTALS
(vaccine failure). Often such infections result in a milder or more attenuated form
of disease, for example, chickenpox developing despite varicella vaccination or
whooping cough developing after 2 or more doses of pertussis vaccine. Vaccine
failure can be categorised in two ways. Primary vaccine failure occurs when
a fully vaccinated person does not form an adequate immune response to that
vaccine. This might occur because a vaccine is defective due to a manufacturing
fault or, more typically, because of inadequate storage (e.g. breakage of the cold
chain) or expiry of the shelf-life. Primary vaccine failure may also occur because
the recipients immune response is ineffective, which may be relatively specific
for that vaccine or part of a broader immunodeficiency. Secondary vaccine
failures occur when a fully vaccinated person becomes susceptible to that disease
over time, usually because immunity following vaccination wanes over time.
As discussed above, the duration of the protective effect of vaccination varies
depending on the nature of the vaccine and the type of immune response elicited,
the number of doses received, and host factors. Some vaccinated persons may get
further immune stimulation from natural infection or colonisation, which aids in
maintaining ongoing protection.
trials and surveillance of disease and vaccine adverse events. One important
component of ensuring that vaccines are safe is to monitor the occurrence of
AEFI. In Australia, there are regional and national surveillance systems that
collect reports of any adverse events following immunisation. All AEFI reported
are added to the national Adverse Drug Reactions System (ADRS) database,
which is operated by the TGA. (See also 2.3 Post-vaccination.) Each year, reports
presenting data and analysis of AEFI in Australia are published in the journal
Communicable Diseases Intelligence, accessible via the Australian Government
Department of Health website (www.health.gov.au/internet/main/publishing.
nsf/content/cda-pubs-cdi-cdiintro.htm).
In some cases, other specific studies will be conducted to ensure that vaccine
safety is closely monitored once a vaccine is in use. For example, the risk of
intussusception (IS) following rotavirus vaccines has been closely monitored
in Australia and elsewhere because of the association of a previously licensed
vaccine with an unacceptably high risk of IS.
Adverse reactions to vaccines (also known as vaccine side effects) do sometimes
occur. It is usually not possible to predict which individuals may have a mild
or, rarely, a serious reaction to a vaccine. However, by following guidelines
regarding when vaccines should and should not be used, the risk of adverse
events can be minimised. As vaccines are usually given to healthy people, any
adverse event that follows soon after immunisation may be perceived as due to
the vaccine. The fact that an adverse event occurs after an immunisation does not
prove the vaccine caused the event. A causal association is rarely certain, but is
most likely when the AEFI is both typical (even if very rare) and when there is
no other plausible explanation, for example, an injection site reaction occurring
a day after vaccination or typical anaphylaxis occurring within minutes of
vaccination. Many AEFIs are less specific and/or have plausible alternative
explanations, including coincidence. Such associations can only be assessed by
large-scale epidemiological studies or specific tests, for example, in the case of
allergy, by allergy testing or challenge. Even when an AEFI is typical, it may be
nonetheless unrelated to vaccination (see 2.3 Post-vaccination).
Vaccine adverse events fall into two general categories: local or systemic. Local
reactions are defined as reactions occurring at the site of vaccine administration
(usually pain, redness or swelling at the injection site) and are generally the least
severe and most frequently occurring AEFI. Systemic reactions most commonly
include fever, headache and lethargy.8,9 Allergic reactions can also occur, although
anaphylaxis, the most severe form of an allergic response, is rarely caused by
vaccination. It is not possible to completely predict which individuals may have a
reaction to a vaccine.
Each chapter in the Handbook indicates under which circumstances vaccine
administration is contraindicated or where precautions are required. A
contraindication to vaccination usually occurs when a person has a pre-existing
condition that significantly increases the chance that a serious adverse event
In 2010, a national review of the management of adverse events that occurred

following influenza vaccine administration was performed.10 The review made a
number of recommendations to further improve the monitoring of vaccine safety
in Australia. Any changes to the system(s) for monitoring or reporting of AEFI
in Australia will be reflected in future updates to the Handbook and will also be
available from the Immunise Australia website (www.immunise.health.gov.au).
References
OF IMMUNISATION
A precaution is a condition that may increase the chance of an adverse event

following immunisation or one that may compromise the ability of the vaccine
to produce immunity. When a precaution exists, there may still be circumstances
when the benefits of giving the vaccine outweigh the potential risks; however,
special care and the provision of appropriate advice to the vaccine recipient may
be required (see 3.3.1 Vaccination of persons who have had an adverse event following
immunisation).
1.5 FUNDAMENTALS
will occur following receipt of a specific vaccine. A contraindication may also

occur when there is insufficient safety data regarding a vaccines use and there
is a theoretical risk of harm. In general, vaccines should not be given where a
contraindication exists, except under advice from your local state or territory
health department (Appendix 1 Contact details for Australian, state and territory
government health authorities and communicable disease control).
PART 2 VACCINATION PROCEDURES

In Australia, vaccination is undertaken predominantly through general practices,
but in some jurisdictions vaccines may be given through local council clinics,
community centres or through school-based immunisation programs. In some
situations, vaccinations may also be given in travel medicine clinics, public
hospitals, staff occupational health clinics and aged care facilities. State or
territory legislation outlines who can access and administer vaccines. All vaccines
must be administered in accordance with the relevant legislation, best practice
and the following Handbook guidelines and recommendations.
2.1 PRE-VACCINATION
The following sections discuss steps and procedures that should occur before a
vaccination encounter.
2.1.1 Preparing an anaphylaxis response kit

The availability of protocols, equipment and drugs necessary for the
management of anaphylaxis should be checked before each vaccination session.
An anaphylaxis response kit should be on hand at all times and should contain:
adrenaline 1:1000 (minimum of three ampoules check expiry dates)
minimum of three 1 mL syringes and 25 mm length needles (for
intramuscular [IM] injection)
cotton wool swabs
pen and paper to record time of administration of adrenaline
laminated copy of adrenaline doses (Table 2.3.2 or back cover of this
Handbook)
laminated copy of Recognition and treatment of anaphylaxis (back cover
of this Handbook).
See 2.3.2 Adverse events following immunisation for details on recognition and
treatment of adverse events following immunisation (in particular, see Use of
adrenaline and Use of adrenaline autoinjectors for anaphylaxis treatment in
that section).
2.1.2 Effective cold chain: transport, storage and handling of vaccines

The cold chain is the system of transporting and storing vaccines within the
temperature range of +2C to +8C from the place of manufacture to the point
of administration.1 Maintenance of the cold chain is essential for maintaining
vaccine potency and, in turn, vaccine effectiveness. This is vital, not only for
those vaccines provided as part of the National Immunisation Program, but also
for vaccines purchased by the patient via prescription from a pharmacist. In such
cases, both the doctor issuing the prescription and the pharmacist dispensing
the vaccine must inform the patient of the need for maintaining, and how to
maintain, the cold chain for the vaccine they have purchased.
All immunisation service providers must be familiar with, and adhere

to, the National vaccine storage guidelines: Strive for 5 (2nd edition).1 This
publication can be accessed free of charge from www.immunise.health.
gov.au/internet/immunise/publishing.nsf/Content/IMM77-cnt
These guidelines also provide instructions on how best to transport vaccines

from the main storage facility to outreach or external clinics. Purpose-built
vaccine refrigerators (PBVR) are the preferred means of storage for vaccines.
Domestic refrigerators are not designed for the special temperature needs of
vaccine storage.
Cold chain breaches

Despite best practices, cold chain breaches sometimes occur. It is important
to report any cold chain breaches so that revaccination of patients or recall of
unused vaccines can be undertaken, if required.
Do not discard or use any vaccines exposed to temperatures below +2C or

above +8C without obtaining further advice. Isolate vaccines and contact
the state/territory health authorities (see Appendix 1) for advice on the
National Immunisation Program vaccines and the manufacturer/supplier
for privately purchased vaccines. Recommendations for the discarding of
vaccines may differ between health authorities and manufacturers.
2.1.3 Valid consent

Valid consent can be defined as the voluntary agreement by an individual to a
proposed procedure, given after sufficient, appropriate and reliable information
about the procedure, including the potential risks and benefits, has been
conveyed to that individual.2-6 As part of the consent procedure, persons to be
vaccinated and/or their parents/carers should be given sufficient information
PART 2 VACCINATION PROCEDURES 25
2.1 PRE-VACCINATION
The National vaccine storage guidelines: Strive for 5 contains specific details on
setting up the infrastructure for a vaccination service, and immunisation service
providers should refer to this document to ensure that satisfactory equipment
and procedures are in place before commencing vaccination services.1
(preferably written) on the risks and benefits of each vaccine, including what
adverse events are possible, how common they are and what they should do
about them7 (the table inside the front cover of this Handbook, Side effects following
immunisation for vaccines used in the National Immunisation Program (NIP) schedule,
can be used for this purpose).
For consent to be legally valid, the following elements must be present:6,8
1. It must be given by a person with legal capacity, and of sufficient intellectual
capacity to understand the implications of being vaccinated.
2. It must be given voluntarily in the absence of undue pressure, coercion or
manipulation.
3. It must cover the specific procedure that is to be performed.
4. It can only be given after the potential risks and benefits of the relevant
vaccine, risks of not having it and any alternative options have been
explained to the individual.
The individual must have sufficient opportunity to seek further details or
explanations about the vaccine(s) and/or its administration. The information
must be provided in a language or by other means the individual can
understand. Where appropriate, an interpreter and/or cultural support person
should be involved.
Consent should be obtained before each vaccination, once it has been established
that there are no medical condition(s) that contraindicate vaccination. Consent
can be verbal or written. Immunisation providers should refer to their state or
territorys policies on obtaining written consent (see Appendix 1 Contact details
for Australian, state and territory government health authorities and communicable
disease control).
Consent on behalf of a child or adolescent

In general, a parent or legal guardian of a child has the authority to consent to
vaccination of that child; however, it is important to check with your state or
territory authority where any doubt exists.2,5 A child in this context is defined
as being under the age of 18 years in Tasmania, Victoria and Western Australia;
under the age of 14 years in New South Wales; and under the age of 16 years
in the Australian Capital Territory, South Australia and the Northern Territory.
Queensland follows common law principles.
For certain procedures, including vaccination, persons younger than the ages
defined above may have sufficient maturity to understand the proposed
procedure and the risks and benefits associated with it, and thus may have the
capacity to consent under certain circumstances. Refer to the relevant state or
territory immunisation service provider guidelines for more information.
Should a child or adolescent refuse a vaccination for which a parent/guardian

has given consent, the child/adolescents wishes should be respected and the
parent/guardian informed.2
Consent on behalf of an adult lacking capacity

A careful assessment should be made of an adults capacity to give valid consent
to a vaccination. If the adult lacks capacity, practitioners should refer to relevant
state and territory laws relating to obtaining consent from a substitute decisionmaker. For example, this may occur for influenza vaccination of an elderly person
with dementia. Refer to the enduring guardianship legislation appropriate for
your state or territory for further advice.
Resources to help communicate the risks and benefits of vaccines
It is preferable that printed information is available to supplement any verbal

explanations.11 The summary table Comparison of the effects of diseases and the side
effects of NIP vaccines inside the back cover of this Handbook provides some basic
information necessary to communicate the risks and benefits of vaccination.
The table can be photocopied and used freely as required.
More detailed information concerning vaccines and their use is available from
the following sources:
The Immunise Australia website includes the booklet Understanding childhood
immunisation, which contains frequently asked questions and links to
state and territory health department websites. Several of these sites offer
multilingual fact sheets.
www.ncirs.edu.au
The National Centre for Immunisation Research and Surveillance of Vaccine
Preventable Diseases website includes fact sheets related to specific vaccines,
vaccine-preventable diseases and vaccine safety. The website also hosts
online decision aids to assist patients in deciding whether to vaccinate or not.
See also Appendix 4 Commonly asked questions about vaccination.
Evidence of consent
General practice or public immunisation clinics
Consent may be given either in writing or verbally, according to the protocols

of the health facility, but it must meet the criteria for valid consent. Evidence
of verbal consent should be documented in the clinical records. If a standard
procedure is routinely followed in a practice or clinic, then a stamp, a sticker
2.1 PRE-VACCINATION
Plain language should be used when communicating information about vaccines

and their use. The person to be vaccinated (or their parent/guardian) must be
encouraged and allowed to ask for further information and have sufficient time
to make a decision about whether to consent or not.9,10
or a providers signature indicating that the routine procedure has been

followed may be used. For paperless medical records, a typed record of
verbal consent may be made in the patients file, or a copy of written consent
scanned into the file.
Explicit verbal consent is required before administration of any vaccine, even
when written consent has been given at previous vaccination encounters for the
same vaccine. Verbal consent should be documented in the patients file each
time it is given.
School-based vaccination programs
Consent is required for provision of individual vaccines or a vaccine course

offered in school-based vaccination programs.
In school-based, and other large-scale, vaccination programs, the parent or
guardian usually does not attend with the child on the day the vaccination is
given, and written consent from the parent or guardian is desirable in these
circumstances. However, if written consent is not able to be provided, or if
further clarification is required, verbal consent may be sought by telephone
from the parent or guardian by the immunisation service provider. This should
be clearly documented on the childs consent form. In some jurisdictions,
older adolescents may be able to provide their own consent for vaccinations
offered through school-based vaccination programs.12 Consent requirements
and vaccines offered in these programs vary between jurisdictions. Refer to the
relevant state or territory school-based vaccination program guidelines for more
information.
2.1.4 Pre-vaccination screening

Immunisation service providers should perform a comprehensive prevaccination health screen of all persons to be vaccinated. For some individuals,
alterations to the routinely recommended vaccines may be necessary to either
eliminate or minimise the risk of adverse events, to optimise an individuals
immune response, or to enhance the protection of a household contact against
vaccine-preventable diseases.
Providers should:
ensure that they have the right person to be vaccinated
ensure which vaccine(s) are indicated, including any previously
missed vaccine doses
consider whether alternative or additional vaccines should be given
check if there are any contraindications or precautions to the vaccines
that are to be given
ensure that the patient to be vaccinated is the appropriate age for the
vaccines to be given
check that the correct time interval has passed since any previous vaccine(s)
or any blood products were given.
See also 2.1.5 Catch-up and relevant disease chapters for further details.
Steps for pre-vaccination screening

Follow these steps to complete the pre-vaccination screening process:
Provide the person to be vaccinated or the parent/carer with the Prevaccination screening checklist (Table 2.1.1).
Some of the questions in this checklist are deliberately non-specific so as to
elicit as much important information as possible.
The checklist may be photocopied and handed to the person to be
vaccinated or the parent/carer just before vaccination.
For vaccination of adults, seek additional information about the occupation

and lifestyle factors that may influence vaccination requirements. This is
discussed in more detail in 2.1.5 Catch-up below under Catch-up schedules
for persons 10 years of age.
If you identify the presence of a condition or circumstance indicated on the
pre-vaccination screening checklist, refer to Table 2.1.2, which lists the specific
issues pertaining to such condition(s) or circumstances and provides the
appropriate action with a rationale.
Where necessary, seek further advice from a specialist immunisation clinic,
a medical practitioner with expertise in vaccination, the immunisation
section within your state or territory health authority, or your local Public
Health Unit (see Appendix 1 Contact details for Australian, state and territory
2.1 PRE-VACCINATION
The checklist may also be photocopied and displayed in the clinic/surgery

for easy reference for the immunisation service provider.
Table 2.1.1: Pre-vaccination screening checklist

Pre-vaccination screening checklist
This checklist helps decide about vaccinating you or your child today. Please
fill in the following information for your doctor/nurse.
Name of person to be vaccinated ______________________________________
Date of birth ________________
Age today __________________
Name of person completing this form __________________________________
Please indicate if the person to be vaccinated:
is unwell today
has a disease that lowers immunity (e.g. leukaemia, cancer, HIV/AIDS) or is
having treatment that lowers immunity (e.g. oral steroid medicines such as
cortisone and prednisone, radiotherapy, chemotherapy)
has had a severe reaction following any vaccine
has any severe allergies (to anything)
has had any vaccine in the past month
has had an injection of immunoglobulin, or received any blood products or
a whole blood transfusion within the past year
is pregnant
has a past history of Guillain-Barr syndrome
was a preterm infant
has a chronic illness
has a bleeding disorder
identifies as an Aboriginal or Torres Strait Islander
does not have a functioning spleen
is planning a pregnancy or anticipating parenthood
is a parent, grandparent or carer of a newborn
lives with someone who has a disease that lowers immunity (e.g. leukaemia,
cancer, HIV/AIDS), or lives with someone who is having treatment
that lowers immunity (e.g. oral steroid medicines such as cortisone and
prednisone, radiotherapy, chemotherapy)
is planning travel
has an occupation or lifestyle factor(s) for which vaccination may be needed
(discuss with doctor/nurse)
Please specify:__________________________________________________
Note: Please discuss this information or any questions you have about
vaccination with your doctor/nurse before the vaccines are given.
Before any vaccination takes place, your doctor/nurse should ask you:
Did you understand the information provided to you about vaccination?
Do you need more information to decide whether to proceed?
Did you bring your/your childs vaccination record card with you?
It is important for you to receive a personal record of your or your childs
vaccinations. If you do not have a record, ask your doctor/nurse to give
you one. Bring this record with you every time you or your child visit for
vaccination. Make sure your doctor/nurse records all vaccinations on it.
The recommended responses for immunisation service providers to make if any

conditions or circumstances are identified by using the pre-screening checklist
are summarised in Table 2.1.2.
Note: Only vaccines recommended on the NIP schedule are included in Table
2.1.2. For information on other vaccines, refer to the relevant disease-specific
chapter in Part 4 of this Handbook or to vaccine product information.
For reference, Table 2.1.3 provides a list of live attenuated vaccines.
Table 2.1.2: R
esponses to relevant conditions or circumstances identified
through the pre-vaccination screening checklist
Condition or
circumstance of person
to be vaccinated
Action
Rationale13-15
Is unwell today:
acute febrile illness
(current T 38.5C)
acute systemic
illness
Defer all vaccines until

afebrile.
To avoid an adverse event

in an already unwell child,
or to avoid attributing
symptoms to vaccination
Note: Children with minor

illnesses (without acute
systemic symptoms/signs)
should be vaccinated.
2.1 PRE-VACCINATION
Conditions or circumstances identified using the pre-vaccination

screening checklist
Condition or
to be vaccinated
Action
Rationale13-15
Has a disease that

lowers immunity or is
receiving treatment that
lowers immunity
Refer to 3.3.3 Vaccination

of immunocompromised
persons.
The safety and

effectiveness of the vaccine
may be suboptimal
in persons who are
immunocompromised.
In some cases, expert

advice may need to be
sought before vaccination
(see Appendix 1).
Live attenuated vaccines

may be contraindicated.
Note: Persons living with

someone with lowered
immunity should be
vaccinated, including with
live viral vaccines (see
below).
Has had anaphylaxis
following a previous
dose of the relevant
vaccine
Do not vaccinate. Seek

further medical advice
to confirm causality
and to assist with other
vaccinations.
Anaphylaxis to a
previous dose of vaccine
is a contraindication to
receiving the same vaccine.
See also Contraindications

to vaccination below.
Has a severe allergy to a
vaccine component
Refer to Appendix 3 for

a vaccine component
checklist.
Do not vaccinate but seek
specialist advice (see
Appendix 1). The patient
may still be able to be
vaccinated, dependent on
the allergy.
Has received a live

attenuated viral
parenteral vaccine* or
BCG vaccine in past 4
weeks
Delay live attenuated

viral parenteral vaccines
by 4 weeks.
Anaphylaxis to a vaccine
component is generally
a contraindication to
The immune response

to a live attenuated
viral vaccine (given
parenterally) may interfere
with the response to a
subsequent live viral
vaccine given within 4
weeks of the first.
Condition or
to be vaccinated
Action
Rationale13-15
Has had any blood

product in the past
7 months, or has
had IM or IV
immunoglobulin
in the past year
Check which product

the person received
and the interval since
administration. Refer to
Table 3.3.6 Recommended
intervals between either
immunoglobulins or blood
products and MMR, MMRV
or varicella vaccination.
Antibodies in these
products may interfere
with the immune response
to MMR, MMRV and
varicella vaccines.
Is planning a pregnancy
or anticipating
parenthood
Ensure women planning

pregnancy and household
members have received
vaccines recommended
for their age group. For
example, 2nd dose of
MMR (if born after 1966);
varicella; dTpa; and/
or have had appropriate
pre-conception serological
testing.
Vaccinating before
pregnancy may prevent
maternal illness, which
could affect the infant,
and may confer passive
immunity to the newborn.
See 3.3.2 Vaccination of

women who are planning
pregnancy, pregnant or
breastfeeding, and preterm
infants.
Advise women not to
become pregnant within
28 days of receiving live
viral vaccines.*
2.1 PRE-VACCINATION
If not eligible, make a

return appointment for this
vaccination, and send a
reminder later if necessary.
The recommended
interval to vaccination
varies depending on the
immunoglobulin or blood
product administered.
Condition or
to be vaccinated
Action
Rationale13-15
Is pregnant
Refer to Table 3.3.1

Recommendations for
vaccination in pregnancy.
There is insufficient
evidence to ensure the
safety of administering live
vaccines during pregnancy.
Influenza vaccine is
recommended for all
pregnant women.
Live vaccines* should
be deferred until after
delivery.
Inactivated vaccines
are generally not
contraindicated in
pregnancy.
Vaccination of household
contacts of pregnant
women should be
completed according to the
NIP schedule.
Has a history of
Guillain-Barr syndrome
(GBS)

immunocompromised persons
and 4.7 Influenza.
Risks and benefits of
influenza vaccine should
be weighed against the
potential risk of GBS
recurrence (seek further
advice as per Appendix 1).
Was born preterm

women who are planning
pregnancy, pregnant or
breastfeeding, and preterm
infants.
Preterm infants born at
<28 weeks gestation and/
or with chronic lung
disease require extra
pneumococcal vaccinations
(see 4.13 Pneumococcal
disease).
Persons with a history

of GBS may be at risk of
recurrence of the condition
following influenza
vaccine.
Preterm infants may be at

increased risk of vaccinepreventable diseases (e.g.
invasive pneumococcal
disease), and may not
mount an optimal immune
response to certain
vaccines (e.g. hepatitis B).
Preterm infants born at

<32 weeks gestation and/
or <2000g birth weight
may require an extra dose
of hepatitis B vaccine
(see 4.5 Hepatitis B).
Condition or
to be vaccinated
Action
Rationale13-15
Has a severe or
chronic illness
See 3.3 Groups with special

vaccination requirements.
Persons with a severe or

chronic illness may be at
increased risk of vaccinepreventable diseases (e.g.
invasive pneumococcal
disease), but may not
mount an optimal immune
response to certain
vaccines.
These persons should

receive recommended
vaccines such as
pneumococcal vaccine
and annual influenza
vaccination.
The safety and

effectiveness of some
vaccines may be
suboptimal in persons who
are immunocompromised
(see above).
See 3.3.5 Vaccination

of persons with bleeding
disorders.
Intramuscular injection
may lead to haematomas
in patients with disorders
of haemostasis.
The subcutaneous route

could be considered
as an alternative to the
intramuscular route; seek
specialist advice (see
Appendix 1).
Identifies as an
Aboriginal or Torres
Strait Islander
See 3.1 Vaccination for

Aboriginal and Torres Strait
Islander people.
See the National
Immunisation Program for
specific recommendations
for Aboriginal and Torres
Strait Islander people.
Does not have a

functioning spleen
See 3.3.3 Vaccination

of immunocompromised
persons, Persons with
functional or anatomical
asplenia.
Check the persons
vaccination status
for pneumococcal,
meningococcal, influenza
and Hib vaccinations.
Some Indigenous persons

are at increased risk of
some vaccine-preventable
diseases, such as influenza,
pneumococcal disease and
hepatitis A.
Persons with an absent

or dysfunctional spleen
are at an increased risk of
severe bacterial infections,
most notably invasive
pneumococcal disease.
2.1 PRE-VACCINATION
Has a bleeding disorder
If there is significant
immunocompromise, they
should not receive live
vaccines* (see above).
Condition or
to be vaccinated
Action
Rationale13-15
Is a parent, grandparent
or carer of an infant
6 months of age
Ensure parents,
grandparents and carers of
infants up to 6 months of
age have been offered all
vaccines recommended for
their age group, including
dTpa.
Persons in close contact

are the most likely sources
of vaccine-preventable
diseases, in particular
pertussis, in the newborn.
Lives with someone who Ensure all recommended

is immunocompromised vaccines (in particular
MMR, varicella and
influenza vaccines)
have been offered to
household members of
immunocompromised
persons.
See above and
3.3.3 Vaccination of
immunocompromised
persons.
Household members are

the most likely sources
of vaccine-preventable
diseases among
immunocompromised
persons (who often are
unable to be vaccinated,
especially with live viral
vaccines).
Is planning travel
See 3.2 Vaccination for

international travel
Travellers may be at
increased risk of certain
vaccine-preventable
diseases.
Has certain occupation

or lifestyle factors
See 3.3 Groups with special

vaccination requirements,
and Catch-up schedules
for persons 10 years
of age in 2.1.5 Catch-up
below.
Workers in certain
occupations (e.g.
healthcare workers and
persons working in early
childhood education and
care), and those with
certain lifestyle factors (e.g.
persons who inject drugs)
may be at increased risk of
certain vaccine-preventable
diseases.
* Live attenuated vaccines are classified in Table 2.1.3 below.

See 4.9 Measles, 4.11 Mumps or 4.18 Rubella for further information.
See 4.2 Diphtheria, 4.12 Pertussis or 4.19 Tetanus for further information.
Table 2.1.3: Live attenuated parenteral and oral vaccines

Live attenuated parenteral vaccines
Live attenuated oral vaccines
Viral
Bacterial
Viral
Bacterial
(Imojev)
BCG
Oral rotavirus
vaccine
Oral typhoid
vaccine
Measles-mumpsrubella (MMR)
Measles-mumpsrubella-varicella
(MMRV)
Varicella
Zoster
Contraindications to vaccination
There are only two absolute contraindications applicable to all vaccines:
anaphylaxis following a previous dose of the relevant vaccine
anaphylaxis following any component of the relevant vaccine.
There are two further contraindications applicable to live (both parenteral and
oral) vaccines:
Live vaccines (see Table 2.1.3) should not be administered to persons
who are significantly immunocompromised, regardless of whether the
immunocompromise is caused by disease or treatment. The exception
is that, with further advice, MMR, varicella and zoster vaccines can be
administered to HIV-infected persons in whom immunocompromise is
mild. (See 3.3.3 Vaccination of immunocompromised persons, and individual
disease-specific chapters.)
In general, live vaccines should not be administered during pregnancy,
and women should be advised not to become pregnant within 28 days of
receiving a live vaccine (see Table 3.3.1 Recommendations for vaccination in
pregnancy in 3.3 Groups with special vaccination requirements).
False contraindications to vaccination

No-one should be denied the benefits of vaccination by withholding
vaccines for inappropriate reasons.
Conditions listed in Table 2.1.4 below are not contraindications to
vaccination. Persons with these conditions should be vaccinated with all
recommended vaccines.
2.1 PRE-VACCINATION
Yellow fever
Table 2.1.4: False contraindications to vaccination

The following conditions are not contraindications to any of the vaccines in the
National Immunisation Program schedule:
mild illness without fever (T <38.5oC)
family history of any adverse events following immunisation
past history of convulsions
treatment with antibiotics
treatment with locally acting (inhaled or low-dose topical) steroids
replacement corticosteroids
asthma, eczema, atopy, hay fever or snuffles
previous pertussis-like illness, measles, rubella, mumps, varicella, herpes
zoster or meningococcal disease
prematurity (vaccination should not be postponed and can be given if
the infant is medically stable). See also 3.3.2 Vaccination of women who are
planning pregnancy, pregnant or breastfeeding, and preterm infants.
history of neonatal jaundice
low weight in an otherwise healthy child
neurological conditions, including cerebral palsy and Down syndrome
contact with an infectious disease
childs mother is pregnant
child to be vaccinated is being breastfed
woman to be vaccinated is breastfeeding
recent or imminent surgery (see also 3.3.6 Vaccination before or after
anaesthesia/surgery)
poorly documented vaccination history.
2.1.5 Catch-up
Every opportunity should be taken to review a persons vaccination history
and to administer the appropriate vaccine(s). If the person has not had
documented receipt of vaccines scheduled in the NIP appropriate for his/her
age, plan and document a catch-up schedule and discuss this with the person
to be vaccinated or their parent/carer. The assessment of vaccination status
should be based on the schedule for the state or territory in which the person
to be vaccinated is residing.
The objective of catch-up vaccination is to complete a course of vaccination and
provide optimal protection as quickly as possible. The information and tables
below will assist in planning a catch-up schedule.
An online catch-up calculator for NIP vaccines is hosted by South Australia

Health (at immunisationcalculator.sahealth.sa.gov.au) and is available to assist in
determining appropriate catch-up schedules for children 7 years of age across
Australia. When using such resources, also check the accuracy of information
provided by referring to your current state/territory immunisation schedule and
the current edition of the Handbook.
If still uncertain about how to plan the catch-up schedule, or for more
complicated catch-up scenarios, seek further advice (see Appendix 1 Contact
details for Australian, state and territory government health authorities and
communicable disease control).
Confirmation of vaccination history

The most important requirement for assessment of vaccination status is to have
written documentation of vaccination. The approach of immunisation service
providers to the problem of inadequate records should be based on the age of the
person to be vaccinated, whether previous vaccines have been given in Australia
or overseas, and the vaccines being considered for catch-up.
Detailed information on the vaccine registers used in Australia and how to
obtain vaccination records is provided in 2.3.4 Immunisation registers, but is also
described briefly below.
Children <7 years of age
The Australian Childhood Immunisation Register (ACIR) commenced on 1

January 1996 and holds records of all vaccinations given since then to children
(between birth and their 7th birthday). Details of a childs immunisation history
can be obtained via the ACIR Enquiry Line (1800653809) or website (www.
humanservices.gov.au/customer/services/medicare/australian-childhoodimmunisation-register). If a childs parent/carer states that vaccines not recorded
on the ACIR have been given, every effort should be made to contact the relevant
immunisation service provider. If confirmation from the nominated provider or
the ACIR cannot be obtained, and no written records are available, the vaccines
should be considered as not received, and the child should be offered catch-up
vaccination appropriate for their age.
Older children and adolescents <18 years of age
No vaccination information is recorded on the ACIR after a child turns 7 years

of age, but any information already held is retained. The information will relate
only to vaccines received between birth and the 7th birthday. Records held for
2.1 PRE-VACCINATION
For recently arrived migrants, the World Health Organization website (www.
who.int/countries/en) lists immunisation schedules provided by other countries,
which may supplement information regarding which vaccines a child/adult
arriving from overseas may have received (see also 3.3.8 Vaccination of migrants
to Australia).
a person who is now 7 years of age can be made available to an immunisation

service provider or parent/carer.
The National HPV Vaccination Program Register (NHVPR, also referred to as
the HPV Register) holds details of human papillomavirus (HPV) vaccinations
reported to the Register since the commencement of the HPV Vaccination
Program in April 2007. The NHVPR initially only recorded vaccinations for
females, but from 2013 will also record vaccinations given to males. Details of
HPV vaccinations held by the NHVPR can be obtained by phoning the Register
on 1800478734 (1800HPVREG). (See also 2.3.4 Immunisation registers.)
In older children and adolescents, alternative sources of documentation (such as
personal health records) will be needed, but are less likely to be available with
increasing age. Persons who do not have personal vaccination records may seek
evidence of past vaccination from their parents, their past and present healthcare
providers or immunisation service providers. Those born after 1990 may have
some vaccinations recorded on the ACIR (see 2.3.4 Immunisation registers).
Information on how to obtain records of vaccines received through school-based
vaccination programs can be obtained from state and territory government health
departments (see Appendix 1 Contact details for Australian, state and territory
Adults (18 years of age)
In adults, patient-held and/or provider-held documentation of previous

vaccination history may not be available. In some cases, information may be
available from other sources, such as the National HPV Vaccination Program
Register and the Australian Q Fever Register. (See also 2.3.4 Immunisation
registers.)
Incomplete documentation of prior vaccination

If receipt of prior vaccination cannot be confirmed via the above methods, it
should generally be assumed that the vaccine(s) required have not been given
previously. All efforts should be made to confirm and ensure appropriate
documentation of prior receipt of vaccines.
For most vaccines (except Q fever), there are no adverse events associated with
additional doses if given to an already immune person. In the case of diphtheria-,
tetanus- and pertussis-containing vaccines and pneumococcal polysaccharide
vaccines, frequent additional doses may be associated with an increase in local
adverse events; however, the benefits of protection may outweigh the risk of an
adverse reaction, for example, protection against pertussis from a booster dose
of dTpa. (See also 4.2 Diphtheria, 4.12 Pertussis, 4.13 Pneumococcal disease or 4.19
Tetanus.) Additional doses of MMR, varicella, inactivated poliomyelitis (IPV) or
hepatitis B vaccines are rarely associated with significant adverse events.
Use of serological testing to guide catch-up vaccination

In some instances, serological testing for immunity from prior vaccination and/
or infection may be useful to guide the need for catch-up vaccination, such
as for measles, hepatitis B and rubella. However, it is important to note that
serological testing is not reliable for vaccine-induced immunity in all instances
and is specifically not recommended to be used to guide the need for catch-up
vaccination for certain diseases/vaccines (e.g. pertussis, pneumococcal disease
and meningococcal disease). In most circumstances, and for most vaccines, it
is more practical to offer vaccination, rather than serological testing. See also
recommendations regarding serological testing before and after vaccination in
various disease chapters (4.4 Hepatitis A, 4.5 Hepatitis B, 4.9 Measles, 4.11 Mumps,
4.18 Rubella, 4.22 Varicella, 4.24 Zoster).
Determining when a vaccine dose is valid according to age and interval

since last dose
A valid vaccine dose is a dose that is considered immunogenic (and safe) given
the age and health status of the recipient and the interval since the recipients
last dose of the same vaccine. For children who are vaccinated at an age younger
than that routinely recommended, or for children and adults in whom the
interval between vaccine doses is shorter than the usual recommended interval,
information regarding both the minimum acceptable age for the 1st dose of
an infant vaccine (Table 2.1.5) and the minimum acceptable intervals between
vaccine doses (Tables 2.1.7 to 2.1.12) can be used to determine whether additional
vaccine doses and/or catch-up vaccination is required. For more details see the
following sections.
Planning catch-up vaccination

This and the following two sections are dedicated to planning catch-up
vaccination. In the following two sections information is presented by age
of the vaccine recipient (children aged <10 years and persons aged 10 years).
A number of tables and figures are provided to help plan a catch-up schedule:
Figure 2.1.1 is a worksheet for calculating and recording which vaccines are
required in children aged <10 years, the number of doses outstanding and
the timing of these doses (see Using the catch-up worksheet (Figure 2.1.1)
for children <10 years of age below).
Table 2.1.5 lists the minimum acceptable ages for the 1st dose of scheduled
vaccines in infants.
2.1 PRE-VACCINATION
Interpretation of the results of serological testing may be enhanced by discussion

with the laboratory that performed the test, ensuring that relevant clinical
information is provided.
Table 2.1.6 can be used to assess the number of doses a child should have
received if they were on schedule. Check under the current age of the child
to see how many doses they should have already received and use that
number of doses as the starting point for calculating a catch-up schedule.
For example, a child who is 18 months old now should have received
3 doses of DTPa, 3 doses of IPV, etc.
Table 2.1.7 lists the minimum acceptable interval between doses under special
circumstances, such as catch-up vaccination. Vaccine doses should not be
administered at less than the acceptable minimum interval.16 In the majority
of instances, doses administered earlier than the minimum acceptable
interval should not be considered as valid doses and should be repeated,
as appropriate, using Table 2.1.6.
Tables 2.1.8 to 2.1.11 are for calculating catch-up for Haemophilus influenzae
type b (Hib) and pneumococcal vaccination of children.
Table 2.1.12 can be used to calculate a catch-up schedule for persons
aged 10 years.
In addition, the following principles should generally be applied when planning
catch-up vaccination:
When commencing the catch-up schedule, the standard scheduled interval
between doses may be reduced or extended, and the numbers of doses
required may reduce with age. For example, from 16 months of age, only
1 dose of (any) Hib vaccine is required.
As a child gets older, the recommended number of vaccine doses may change
(or even be omitted from the schedule), as the child becomes less vulnerable
to specific diseases.
For incomplete or overdue vaccinations, build on the previous documented
doses. In almost every circumstance, it is advisable to not start the schedule
again, regardless of the interval since the last dose, but to count previous
doses. One exception to this rule is for oral cholera vaccine (see 4.1 Cholera).
If more than one vaccine is overdue, 1 dose of each due or overdue vaccine
should be given at the first catch-up visit. Further required doses should be
scheduled after the appropriate minimum interval (see Table 2.1.7).
A catch-up schedule may require multiple vaccinations at a visit. Give all the
due vaccines at the same visit do not defer. See 2.2.9 Administering multiple
vaccine injections at the same visit.
The standard intervals and ages recommended in the NIP schedule should be
used once the child or adult is up to date with the schedule.
Some persons will require further doses of antigens that are available only
in combination vaccines. In general, the use of the combination vaccine(s)
is acceptable, even if this means the number of doses of another antigen
administered exceeds the required number.
For some vaccines, catch-up vaccination is not recommended. For

example, rotavirus vaccination is not recommended if the 1st (and
subsequent) vaccine doses are not able to be provided within the
prescribed upper age limits (see Catch-up guidelines for individual
vaccines for children <10 years of age below).
Using the catch-up worksheet (Figure 2.1.1) for children <10 years of age
A catch-up schedule for a child <10 years of age should be planned by taking
into account the guidelines above in conjunction with the catch-up tables (listed
above). The catch-up worksheet (Figure 2.1.1) provides a method of recording
these steps.
To use the catch-up worksheet:
2. For each vaccine, determine how many doses have been received and the date
that the last dose was given. Record this in the Last dose given column of the
worksheet. If documentation is adequate, include previous vaccinations given
in another country (receipt of these vaccines should be entered onto the ACIR
for a child <7 years of age see 2.3.4 Immunisation registers).
3. Refer to Table 2.1.6 to check how many doses of each vaccine are required for
the childs current age. Enter this number in the Number of doses required at
current age column of the worksheet.
4. Assess other factors that may affect the type or number of vaccines required.
These should have been ascertained during pre-vaccination screening (see
2.1.4 Pre-vaccination screening above, the pre-vaccination screening check list
[Table 2.1.1] and table of responses [Table 2.1.2]) and may include:
anaphylaxis to any vaccine or one of its components (that vaccine is
contraindicated)
immunocompromise due to disease or treatment (see 3.3 Groups with
special vaccination requirements)
children identifying as Aboriginal or Torres Strait Islander (see 3.1
Vaccination for Aboriginal and Torres Strait Islander people)
children with underlying medical risk condition(s) that predisposes them
to invasive pneumococcal disease (see 4.13 Pneumococcal disease)
preterm infants born at <32 weeks gestation (see Hepatitis B vaccine and
Pneumococcal conjugate vaccines (13vPCV and 10vPCV) in Catch-up
guidelines for individual vaccines for children <10 years of age below).
Record any factors that affect the schedule in the Comments column beside
the relevant vaccine.
2.1 PRE-VACCINATION
1. Record the childs details, including date of birth and current age in the
top left corner of the worksheet.
5. If any variations to the schedule are necessary due to recorded factors (e.g. a
child who is immunocompromised may require different vaccines), adjust the
number of doses required accordingly.
6. For each vaccine, compare the number of doses received, as recorded in the
Last dose given column, with the number of doses required for the childs
current age.
7. If the child has already received the number of doses required for a
particular vaccine, cross through the relevant Dose number due now and
Further doses columns. Ensure that the minimum acceptable interval has
been observed for all doses previously received, particularly if the child
commenced their vaccination program overseas.
8. If the number of doses received, as recorded in the Last dose given column,
is less than the number of doses required, administer a dose of the relevant
vaccine now, and record this in the Dose number due now column. If
this dose still does not complete the required doses, enter the further dose
numbers in the Further doses column.
9. To schedule the next dose at the most appropriate time (usually at the
earliest opportunity), refer to Table 2.1.7 for the minimum acceptable interval
required between doses. Record when the next dose is due in the Further
doses column.
10. Convert this information into a list of proposed appointment dates,
detailing vaccines and dose number needed at each visit on the Catch-up
appointments section of the worksheet.
11. Record this catch-up schedule in your provider records and provide a copy to
the childs parent/carer.
12. Once a child has received relevant catch-up vaccines, give the remaining
scheduled vaccines as per the recommended NIP schedule. For example, for a
12-month-old child who is brought up to date with all vaccines including the
12-month vaccinations, the 2nd dose of MMR-containing vaccine should be
given at 18 months of age, not 4 weeks after the last received dose.
Figure 2.1.1: Catch-up worksheet for children <10 years of age for NIP vaccines
This worksheet can be used in conjunction with Tables 2.1.6 and 2.1.7.
CATCH-UP WORKSHEET
Name:
DOB:
Age:
Last dose
given
Dose
number and
date
Number
of doses
required at
current age*
Dose
number
due now
Further
doses
Comments
Interval
or date
DTPa
Poliomyelitis
(IPV)
2.1 PRE-VACCINATION
Hepatitis A
Hepatitis B
Hib
Pneumococcal
(13vPCV)
Pneumococcal
(23vPPV)
MenCCV
MMR
DO NOT give
after upper
age limits for
each dose.
See 4.17
Rotavirus,
Table 4.17.1.
Rotavirus
Varicella
CATCH-UP APPOINTMENTS
Date
Vaccines and
dose number
Interval to
next dose
Comments
* Refer to Table 2.1.6 Number of vaccine doses that should have been administered by the current age of the
child and Table 2.1.7 Minimum acceptable dose intervals for children <10 years of age.
See Table 2.1.8 for Hib vaccine catch-up recommendations.
See Tables 2.1.9, 2.1.10 and 2.1.11 for pneumococcal vaccine catch-up recommendations.
Previous doses of pneumococcal conjugate vaccine may have been given using 7-valent (7vPCV)
or 10-valent (10vPCV) vaccine(s).
Table 2.1.5: M
inimum acceptable age for the 1st dose of scheduled vaccines in
infants in special circumstances*
Vaccine
Minimum age
for 1st dose
in special
circumstances*
Action if a vaccine dose is inadvertently

administered prior to the recommended
minimum age17
DTPa
6 weeks
If the 1st dose of DTPa-containing vaccine

was administered at 28 days of age, it is
recommended that the dose is repeated. This
repeat dose should be given at 2 months of age.
The NIP schedule should be followed thereafter,
with the next dose of DTPa-containing vaccine
given at 4 months of age.
If the 1st dose of DTPa-containing vaccine
was administered between >28 days and
<42 days (6 weeks) of age, it does not necessarily
need to be repeated. Limited data suggest that
administration at this age will still be safe and
immunogenic. The NIP schedule should be
followed thereafter, with the next dose of DTPacontaining vaccine given at 4 months of age.
Poliomyelitis
(IPV)
6 weeks
See DTPa-containing vaccines above.
Hib
6 weeks
Hepatitis B
6 weeks
(Note: this
excludes
birth dose of
hepatitis B
vaccine)
Pneumococcal
(13vPCV or
10vPCV)
6 weeks
If the 1st dose of PCV was administered at

28 days of age, it is recommended that the dose
is repeated. This repeat dose should be given at
2 months of age. The NIP schedule should be
followed thereafter, with the next dose of PCV
If the 1st dose of PCV was administered between
>28 days and <42 days (6 weeks) of age, it does
not necessarily need to be repeated. Limited data
suggest that administration at this age will still
be safe and immunogenic. The NIP schedule
should be followed thereafter, with the next dose
of PCV given at 4 months of age.
Vaccine
Minimum age
for 1st dose
in special
circumstances*
Action if a vaccine dose is inadvertently

administered prior to the recommended
minimum age17
Rotavirus
6 weeks
If the 1st dose of rotavirus vaccine was

administered at 28 days of age, it is
recommended that the dose is repeated.
This repeat dose should be given at 2 months
of age. The NIP schedule should be followed
thereafter, with the next dose of rotavirus vaccine
For all doses of rotavirus vaccine it is important

to ensure the upper age limits for dose
administration are not exceeded (see 4.17
Rotavirus, Table 4.17.1).
MenCCV
6 weeks
If any MenCCV doses are given before 12 months

of age, then a booster dose of MenCCV should
be given at 12 months of age or 8 weeks after the
last dose, whichever is later.
Note: MenCCV is routinely recommended at
12 months of age, although recommendations
for children at increased risk of meningococcal
disease differ (see 4.10 Meningococcal disease).
Hepatitis A
(Indigenous
children in
NT, Qld, SA
and WA only)
12 months
If the 1st dose of hepatitis A vaccine is

administered at <12 months of age, and ongoing
protection against hepatitis A is required, the 1st
dose should be repeated.
MMR
12 months
MMR vaccine may be given from 9 months

of age, in certain circumstances, such as for
post-exposure prophylaxis for measles (see 4.9
Measles), but it is recommended that the 1st dose
be repeated if it was given at <12 months of age.#
See note on MMRV below.
Varicella**
12 months
If a varicella-containing vaccine is administered

at <12 months of age, the dose should be
repeated, preferably at 18 months of age.
See note on MMRV below.
2.1 PRE-VACCINATION
If the 1st dose of rotavirus vaccine was

administered between >28 days and <42 days
(6 weeks) of age, it does not necessarily need
to be repeated. Limited data suggest that
administration at this age will still be safe
and immunogenic. The NIP schedule should
be followed thereafter, with the next dose of
rotavirus vaccine given at 4 months of age.
* Special circumstances may include infants/children being vaccinated during an outbreak of a

certain disease, before overseas travel, or opportunistic vaccination following early attendance
to a provider. These ages will often differ from routinely recommended ages of administration
under the NIP schedule. In some instances, these ages will also result in the dose not being
considered by the Australian Childhood Immunisation Register (ACIR) as valid for the purpose
of calculating immunisation status. If the ACIR age requirement differs from the minimum ages
in this table, this is noted.
If the need to repeat the 1st dose of vaccine is not recognised until the infant is older (e.g. a
4-month-old infant presents for vaccination and has only previously received 1 dose of DTPahepB-IPV-Hib or 13vPCV vaccines both at age 28 days), repeat these vaccines now (and
count these as dose 1), then proceed with subsequent schedule as per NIP and/or catch-up
recommendations for these vaccines described in this chapter.
The minimum age from which the combination vaccine DTPa-hepB-IPV-Hib (or the antigens
contained within it) is considered a valid dose on the ACIR is 1 month (>28 days) of age.17
M
onovalent hepatitis B vaccine should be given at birth (up to 7 days of age). However, for
subsequent doses where hepatitis B-containing combination vaccine is given at 2, 4 and 6 months
of age, the minimum age for the 1st dose (scheduled at age 2 months) is 6 weeks of age. If an
infant has not received a birth dose within the first 7 days of life, a primary 3-dose course of a
hepatitis B-containing combination vaccine should be given at 2, 4 and 6 months of age; catch-up
of the birth dose is not necessary.
MMRV vaccine is recommended as the 2nd (not 1st) dose of MMR-containing vaccine in
children <4 years of age. However, if MMRV has been inadvertently given as the 1st dose of
MMR-containing vaccine, that MMR-containing dose does not need to be repeated, unless it was
provided at <12 months of age (as per MMR and monovalent varicella vaccines).
#N
ote: The ACIR will record MMR vaccine given at 11 months of age as a valid dose, for
purposes of calculating immunisation status. There is some evidence that a dose provided at 11
months (but before 12 months) of age is sufficiently immunogenic, especially in infants born to
mothers with measles antibody derived from vaccination rather than natural infection. As such,
doses given in this timeframe may not need to be repeated in all circumstances.17
** One monovalent varicella vaccine, Varilrix, is registered for use from 9 months of age, and
can be provided from 9 months of age in special circumstances, for example, prior to travel.
However, if a dose has been provided at <12 months of age, it should be repeated.
Table 2.1.6: N
umber of vaccine doses that should have been administered by
the current age of the child
This table can be used in conjunction with Figure 2.1.1 Catch-up worksheet for children
<10 years of age for NIP vaccines.
Vaccine
Current age
0 to <2 2 to <4
months months
4 to <6 6 to <12
months months
12 to 18
months
>18
months
to <4
years
4 years
to
<10
years
Poliomyelitis
(IPV)
Hepatitis A
Hepatitis B
Hib
Complex see Table 2.1.8 for Hib vaccine catch-up
Pneumococcal Complex see Tables 2.1.9, 2.1.10 and 2.1.11 for pneumococcal vaccine
(13vPCV and catch-up
23vPPV)
MenCCV
MMR
Rotavirus#
There are specific age limits

as per 4.17 Rotavirus, Table
4.17.1
NO CATCH-UP
Varicella
* Some children may have received 4 doses of DTP by 18 months of age, especially if arrived from
overseas. These children will require a 5th dose of DTPa at 4 years of age.
If the 3rd dose of IPV is given after 4 years of age, a 4th dose is not required. However, if using a
combination vaccine it is acceptable to give a 4th dose.
Indigenous children resident in the Northern Territory, Queensland, South Australia and Western
Australia only. Dependent on jurisdiction, the 1st dose is given at 1218 months of age, followed
by the 2nd dose 6 months later at 1824 months of age. Consult relevant state/territory health
authorities for advice regarding catch-up in children >2 years of age.
A birth dose of monovalent hepatitis B vaccine is recommended for all infants; however, if this
was not given, a catch-up birth dose is not necessary. Where the birth dose was given, in the
usual circumstances where hepatitis B-containing combination vaccines for children are used
for catch-up, a further 3 doses of hepatitis B-containing vaccine are required. In the unusual
circumstance where a child requires catch-up only for hepatitis B vaccination, the standard
monovalent hepatitis B vaccination schedule of 0, 1, 6 months can be adopted to work out the
remaining number of doses required and intervals of the catch-up schedule (see 4.5 Hepatitis B).
MMRV can be given as the 2nd dose of MMR-containing vaccine where both MMR and varicella
are required (see 4.9 Measles and 4.22 Varicella).
# There is no catch-up for rotavirus vaccine (see 4.17 Rotavirus).
2.1 PRE-VACCINATION
DTPa*
Table 2.1.7: Minimum acceptable dose intervals for children <10 years of age
This table can be used in conjunction with Figure 2.1.1 Catch-up worksheet for children
<10 years of age for NIP vaccines and Table 2.1.6 Number of vaccine doses that should
have been administered by the current age of the child.
Note: These are not the routinely recommended intervals between vaccine doses. These minimum
intervals are only to be used under special circumstances, such as when catch-up vaccination
is required until a child is back on schedule for their age. These intervals may differ from the
routinely recommended intervals between doses under the NIP schedule.
Vaccine
Minimum interval
between dose 1 and 2
Minimum interval
Minimum interval
4 weeks
4 weeks
6 months
Poliomyelitis (IPV)
4 weeks
4 weeks
4 weeks
Hepatitis A
6 months
Hepatitis B
1 month
DTPa*
2 months
Hib
See Table 2.1.8 for Hib vaccine catch-up
Pneumococcal
(13vPCV and 23vPPV)
See Tables 2.1.9, 2.1.10 and 2.1.11 for pneumococcal vaccine catch-up
MenCCV
MMR#
Rotavirus
4 weeks
**
Varicella#
Rotarix
4 weeks
RotaTeq
4 weeks
4 weeks
4 weeks
* If DTPa is only available in combination with other antigens (e.g. DTPa-IPV or DTPa-hepB-IPVHib), these formulations can be used where necessary for primary course or catch-up doses in
children <10 years of age.
If the 3rd dose of IPV is given after 4 years of age, a 4th dose is not required. However,
if using a combination vaccine, it is acceptable to give a 4th dose.
Indigenous children resident in the Northern Territory, Queensland, South Australia and
Western Australia only.
T
his excludes the birth dose. The minimum interval between the birth dose (which can be
regarded as dose 0 [zero] for the purposes of this table) and the next hepatitis B-containing
dose (usually given as DTPa-hepB-IPV-Hib at 2 months of age) is 4 weeks. For the 3 hepatitis
B-containing doses (usually given as DTPa-hepB-IPV-Hib at 2, 4 and 6 months of age) the
minimum intervals in this table apply. The minimum interval required between dose 1 and dose
3 is 4 months and the minimum age for administration of dose 3 is 24 weeks (see 4.5 Hepatitis B).
The routine schedule is a single dose given at 12 months of age. Alternative schedules are
available for children <12 months of age (see 4.10 Meningococcal disease).
# MMR is recommended as the 1st dose of MMR-containing vaccine in children <4 years of age
(see 4.9 Measles). MMRV is recommended to be given as the 2nd dose of MMR-containing
vaccine. MMRV can be given 4 weeks following the 1st catch-up dose of MMR vaccine or as
catch-up for the 2nd dose of MMR where varicella is also required.
** Refer to 4.17 Rotavirus, Table 4.17.1 for upper age limits for administration of rotavirus
vaccines. Catch-up is not recommended.
Two doses of varicella-containing vaccine are not routinely recommended in children
<14 years of age; however, a 2nd dose can be provided to offer increased protection against
varicella (see 4.22 Varicella).
Catch-up guidelines for individual vaccines for children <10 years of age
DTPa vaccine
Monovalent pertussis vaccine is not available in Australia. If a child has

received previous doses of diphtheria-tetanus (DT) vaccines and requires
pertussis catch-up, then DTPa or DTPa-combination vaccines can be used,
provided that no more than 6 doses of diphtheria and tetanus toxoids are given
before the 10th birthday (see 4.12 Pertussis).
If a DTPa-hepatitis B-containing combination vaccine is used, there should be a
minimum interval of 8 weeks between doses 2 and 3, as per the minimum interval
requirements for the hepatitis B vaccine.
Hepatitis B vaccine
In the unusual circumstance where a child requires catch-up vaccination only

for hepatitis B, but not any other components in the hepatitis B-containing
combination vaccines, the standard monovalent hepatitis B vaccination schedule
of 0, 1, 6 months can be used for the remaining dose(s) if required (see 4.5
Hepatitis B).
In preterm (<32 weeks gestation) or low-birth-weight infants (<2000g birth
weight) it is recommended to give hepatitis B vaccine at birth, 2, 4 and 6 months
of age, followed by either serological testing for anti-HBs or a booster at
12 months of age. For details, see 3.3.2 Vaccination of women who are planning
pregnancy, pregnant or breastfeeding, and preterm infants and 4.5 Hepatitis B.
Hib vaccine
The recommended number of doses and intervals for Hib vaccines vary with the
vaccine type and age of the child. For catch-up recommendations see Table 2.1.8.
PRP-OMP is the Hib formulation contained in Liquid PedvaxHIB. PRP-T is
the Hib formulation contained in the other Hib-containing vaccines: Act-HIB,
Hiberix, Infanrix hexa, Menitorix and Pediacel. Where possible, the same brand
of Hib-containing vaccine should be used for all primary doses. If different Hib
vaccines (i.e. PRP-OMP and PRP-T vaccines) are used in the primary series,
then 3 doses (of any Hib vaccine) are required for the primary series, at 2, 4 and
6 months of age, with a booster of a Hib-containing vaccine at 12 months of age.
For extremely preterm and/or low-birth-weight infants (<28 weeks gestation or
<1500g birth weight), 4 doses of a Hib-containing vaccine (irrespective of the
brand used) should be given, at 2, 4, 6 and 12 months of age (see 3.3.2 Vaccination
of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants).
See also 4.3 Haemophilus influenzae type b.
2.1 PRE-VACCINATION
The birth dose hepatitis B vaccine is only scheduled for infants up to 7 days of
age. If this dose was not given, a catch-up birth dose is not necessary. Where the
birth dose was given, and where hepatitis B-containing combination vaccines for
children are used (for routine vaccination or for catch-up), a further 3 doses of
hepatitis B-containing vaccine are required (see 4.5 Hepatitis B).
MMR vaccine, MMRV vaccine and varicella vaccine
If no previous documented doses have been given, catch-up for MMR vaccine
consists of 2 doses of MMR-containing vaccine, given at least 4 weeks apart
(see 4.9 Measles). If no previous documented varicella vaccination has been
given, a single dose of varicella-containing vaccine is recommended in children
aged <14 years (see 4.22 Varicella).
If a child receives varicella vaccine at <12 months of age, a further dose should
be given at 18 months of age. In this circumstance MMRV vaccine may be given
where the 2nd dose of MMR vaccine and a dose of varicella vaccine are both
required (see below and 4.22 Varicella).
MMRV vaccines should only be administered as the 2nd dose of MMRcontaining vaccine in children <4 years of age. If no previous doses of MMR
vaccine have been administered in a child aged >12 months and <4 years, MMR
vaccine should be administered as the 1st dose and then MMRV vaccine can be
administered 4 weeks later as the 2nd dose of MMR-containing vaccine. MMRV
can be used as the 1st dose of MMR-containing vaccine in children 4 years of
age, up to age 14 years (see 4.9 Measles and 4.22 Varicella).
Meningococcal C conjugate vaccine
Meningococcal C conjugate vaccine (MenCCV) is recommended on the NIP as a

single dose for children at 12 months of age. If no dose was received at
12 months of age (or if dose(s) were received at <12 months of age), a single
dose of any meningococcal conjugate vaccine is recommended (see 4.10
Meningococcal disease). Additional MenCCV doses and 4vMenCV doses are
recommended for certain children at increased risk of meningococcal disease
(see Persons with functional or anatomical asplenia in 3.3.3 Vaccination of
immunocompromised persons, and 4.10 Meningococcal disease).
Menitorix (combined Hib-MenCCV) can be administered when a booster dose of
Haemophilus influenzae type b (Hib) and primary vaccination for meningococcal C
is required (see 4.3 Haemophilus influenzae type b and 4.10 Meningococcal disease).
Pneumococcal conjugate vaccines (13vPCV and 10vPCV)
The number of doses and recommended intervals of 13vPCV required for catchup vaccination vary with the age of the child, their health and Indigenous status,
and the state or territory of residence (see Tables 2.1.9, 2.1.10 and 2.1.11 below).
Table 2.1.9 is for children who are not at increased risk of invasive pneumococcal
disease (IPD) (including Indigenous children living in the Australian Capital
Territory, New South Wales, Victoria and Tasmania). Table 2.1.10 is for
Indigenous children residing in the Northern Territory, Queensland, South
Australia and Western Australia. Table 2.1.11 provides catch-up details for
children with a medical condition(s) associated with an increased risk of IPD.
(See also 4.13 Pneumococcal disease.)
If 13vPCV is not available, and 10vPCV is being used, 10vPCV is recommended

in a 4-dose schedule. (See also 4.13 Pneumococcal disease.) If catch-up is required
for 10vPCV, vaccination can be done according to the information provided in
Table 2.1.10.
Children aged 5 years who are not at increased risk of invasive pneumococcal
disease (including Indigenous children aged 5 years) do not require catch-up
doses of PCV.
Preterm infants born at <28 weeks gestation should receive extra doses of
pneumococcal vaccines, in accordance with the schedule for those at increased
risk of IPD (see 4.13 Pneumococcal disease and 3.3.2 Vaccination of women who are
planning pregnancy, pregnant or breastfeeding, and preterm infants).
Poliomyelitis vaccine
If the 3rd dose of IPV is administered before 4 years of age, give the 4th (booster)
dose at either the 4th birthday or 4 weeks after the 3rd dose, whichever is later. If
the 3rd dose is given after the 4th birthday, a 4th dose is not required. However, if
the use of combination vaccines is necessary, a further IPV-containing dose may
be given.
Rotavirus vaccine
Catch-up rotavirus vaccination of older infants or children is not recommended.

Infants should commence the course of rotavirus vaccination within the
recommended age limits for the 1st dose; that is, the 1st dose of RotaTeq should
be given between 6 and 12 weeks of age (i.e. before turning 13 weeks old), and
the 1st dose of Rotarix should be given between 6 and 14 weeks of age (i.e.
before turning 15 weeks old). It is recommended that vaccine doses are not given
beyond the upper age limits specified in Table 4.17.1 (see 4.17 Rotavirus).
2.1 PRE-VACCINATION
If no previous doses of poliomyelitis vaccine have been given, give 3 doses of IPV
or IPV-containing vaccines at least 4 weeks apart (see 4.14 Poliomyelitis). (Previous
doses of OPV are interchangeable with IPV.)
Table 2.1.8: C
atch-up schedule for Haemophilus influenzae type b (Hib)
vaccination for children <5 years of age*
Number
of Hib
doses given
previously
No previous
doses
1 previous
dose
2 previous
doses
Current age Age when previous dose(s) of

Hib vaccine given
Recommendations
Number Number of
booster
of further
doses
primary
required
dose(s)
required at age 12
months
1st
dose
2nd
dose
3rd
dose
<7 months
1
1
711 months
1215 months
1659 months
Not
needed
<7 months
<7 months
711 months
<7 months
711
months
1215 months <12 months
12 months
Not
needed
1659 months <16 months
Not
needed
16 months
Not
needed
Not
needed
Not
needed
1215
months
Not
needed
711
months
715
months
Not
needed
1215
months
1215
months
Not
needed
Not
needed
Any age
16 months
Not
needed
Not
needed
<12 months
<7 months <12 months

711
months
711
months
1259 months <7 months <12 months
Number
of Hib
doses given
previously
Current age Age when previous dose(s) of

Hib vaccine given
3 previous
doses
711 months
1st
dose
2nd
dose
3rd
dose
Any age
Any age
Any age
Recommendations
Number Number of
of further
booster
primary
doses
dose(s)
required
required at age 12
months
1
Not
needed
1215
months
Not
needed
1#
1215
months
1215
months
Not
needed
Not
needed
711
months
715
months
1215
months
Not
needed
Not
needed
Any age
Any age
16 months
Not
needed
Not
needed
1259 months <7 months <12 months <12 months
* Recommendations for vaccination of haematopoietic stem cell transplant (HSCT) recipients

differ; see Table 3.3.3 Recommendations for revaccination following haematopoietic stem cell transplant
(HSCT) in children and adults, irrespective of previous immunisation history.
This column lists the number of further primary doses that should be scheduled for the child,
based on their current age. The recommended interval between primary doses for catch-up is 1
month. Where possible, it is recommended to schedule the required remaining primary doses to
be given prior to 12 months of age. If there are further delays in the scheduled catch-up primary
dose(s), the number of doses required should be checked again against the childs age at each
presentation.
This column lists the number of booster doses that should be scheduled for the child, based on
their current age. Booster doses are to be given at age 12 months or 2 months after the last dose
of Hib vaccine, whichever is later.
One less dose is required if PRP-OMP is to be used for the entire primary course, or if PRP-OMP
has already been given for all previous doses. If PRP-T has been given as one or more of the
doses in the primary course, plan for the number of doses as specified in this table. PRP-OMP is
the Hib formulation contained in Liquid PedvaxHIB. PRP-T is the Hib formulation contained in
the other Hib-containing vaccines: ACT-Hib, Hiberix, Infanrix hexa, Menitorix and Pediacel.
A booster dose is not needed if the last previous dose was given at 16 months of age.
# This booster dose is not required if PRP-OMP was used for both the 1st and the 2nd (primary)
doses of Hib vaccine in infancy, since the 3rd dose of Hib vaccine received at age 1215 months
would have served as the booster dose for these children.
2.1 PRE-VACCINATION
Not
needed
<7 months
759 months
2459 months
1223 months
<12 months
1259 months
711 months
<7 months
<7 months
12 months
Any age
Any age
7 months
Any age
Any age
Any age
<12 months
<7 months
711 months
711 months
Any age
<12 months
<7 months
<12 months
3rd dose
12 months
711 months
711 months
2nd dose
Age when previous dose of any PCV* was given

1st dose
1259 months
<7 months
Age at presentation
Not needed
Not needed
Not needed
Not needed
Not needed
Not needed
Number of further
dose(s) required
Recommended interval between primary doses for catch-up is 12 months. Where possible, it is recommended to align doses with the standard schedule
points at 4 months and 6 months of age for infants aged <7 months. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months
if aged 12 months.
* Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. Use 13vPCV as the vaccine formulation for further catch-up
doses required, regardless of which formulation of PCV the child received previously.
3 previous doses
2 previous doses
1 previous dose
No previous doses
Number of doses
given previously
Table 2.1.9: C
atch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous children, and Indigenous children residing
in the Australian Capital Territory, New South Wales, Tasmania and Victoria, who do not have any medical
condition(s) associated with an increased risk of invasive pneumococcal disease (IPD), aged <5 years
1 previous dose
No previous
doses
Number of doses
given previously
<7 months
<7 months
711 months
1223 months
2459 months
<7 months
2459 months
1223 months
711 months
<7 months
711 months
<12 months
12 months
<12 months
12 months
2nd dose
3rd dose
Age when previous dose of any PCV was given

1st dose
Age at
presentation
Not needed
Not needed
1
Not needed
Not needed
Number of
booster 13vPCV
doses required
Not needed
Number
of further
primary dose(s)
required
Recommendations
Table 2.1.10: C
atch-up schedule for 13vPCV* (Prevenar 13) for Indigenous children residing in the Northern Territory,
Queensland, South Australia or Western Australia ONLY, who do not have any medical condition(s) associated
with an increased risk of invasive pneumococcal disease (IPD), aged <5 years
2.1 PRE-VACCINATION
<12 months
12 months
2459 months
1223 months
Any age
711 months
<7 months
Any age
711 months
Not needed
12 months
Any age
Any age
Not needed
12 months
12 months
711 months
Not needed
Not needed
Any age
Not needed
Any age
Not needed
Not needed
Not needed
Not needed
Any age
Not needed
Number
of further
primary dose(s)
required
Not needed
Not needed
Not needed
Not needed
Not needed
Number of
booster 13vPCV
doses required
Recommendations
<12 months
Any age
12 months
12 months
Any age
Any age
711 months
<7 months
711 months
711 months
<12 months
<7 months
3rd dose
2nd dose
1st dose
2459 months
1223 months
<12 months
Age at
presentation
A minimum interval of 2 months is required after the last dose of 13vPCV in the primary course.
points at 4 months and 6 months of age for infants aged <7 months. The minimum interval between dose(s) is 1 month if aged <12 months, and 2 months
if aged 12 months.
Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. 13vPCV should be used as the vaccine formulation for further
catch-up doses required, regardless of which formulation of PCV the child received previously.
* If 13vPCV is not available, and 10vPCV is being used for all/any children, 10vPCV is recommended in a 4-dose schedule for infants (i.e. at ages 2, 4, 6 and
1218 months). If catch-up is required for 10vPCV, vaccination can be done according to the information provided in this Table. (See also 4.13 Pneumococcal
disease.)
3 previous doses
2 previous doses
Number of doses
given previously
1 previous
dose
No previous
doses
Number of
doses given
previously
<7 months
<7 months
1223 months
711 months
<7 months
1223 months
711 months
<12 months
12 months
2nd dose
<7 months
1st dose
3rd dose
711 months
Age at
presentation
1
1
1
Not needed
Number
Number of
Number
of further
booster doses
of doses
primary dose(s) of 13vPCV
of 23vPPV
of 13vPCV
required at
required at
required
age 12months age 45 years
Recommendations
For children with a medical condition(s) associated with an increased risk of IPD presenting at age 2 years, see recommendations in 4.13
Pneumococcal disease and Table 4.13.2.
associated with an increased risk of invasive pneumococcal disease (IPD),* presenting at age <2 years
Table 2.1.11: Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with a medical condition(s)
2.1 PRE-VACCINATION
1223 months
711 months
1223 months
<12 months
Age at
presentation
<12 months
12 months
711 months
<7 months
Not needed
12 months
711 months
12 months
Not needed
Not needed
Not needed
The booster dose of 13vPCV should be given at the earliest opportunity after the child reaches 12 months of age, but a minimum interval of 2 months is
required after the last dose of 13vPCV in the primary course.
points at 4 months and 6 months of age for infants aged <7 months. The minimum interval between dose(s) is 1 month if age <12 months, and 2 months if
age 12 months.
Prior PCV doses may have been given as 7vPCV (e.g. from overseas), 10vPCV or 13vPCV. 13vPCV should be used as the vaccine formulation for further
catch-up doses required, regardless of which formulation of PCV the child received previously.
Recommendations for vaccination of haematopoietic stem cell transplant (HSCT) recipients differ; see Table 3.3.3 Recommendations for revaccination
following HSCT in children and adults, irrespective of previous immunisation history.
Not needed
Not needed
Any age
12 months
<12 months
Not needed
Not needed
Not needed
Not needed
Not needed
Any age
Recommendations
Number
Number of
Number
of further
booster doses
of doses
primary dose(s) of 13vPCV
of 23vPPV
of 13vPCV
required at
required at
required
age 12months age 45 years
Any age
12 months
12 months
Any age
Any age
711 months
<7 months
711 months
711 months
<12 months
<7 months
3rd dose
2nd dose
1st dose
* Refer to List 4.13.1 in 4.13 Pneumococcal disease for the list of specified conditions.
3 previous
doses
2 previous
doses
Number of
doses given
previously
Catch-up schedules for persons 10 years of age

Catch-up is much less commonly required for this age group than for young
children. Nevertheless, issues surrounding booster doses or revaccinations are
common, particularly in adults. Persons who did not have natural infection
as children but were not vaccinated remain at unnecessary risk of vaccinepreventable diseases.
In general, the same principles for catch-up vaccination apply as for younger
children. For example, if a vaccine course is incomplete, do not start the course
again, regardless of the interval since the last dose. One exception to this rule is
for oral cholera vaccine (see 4.1 Cholera).
Health
Age
Lifestyle
Occupation
The schedule for each individual adult may differ because of the risk factors
identified when applying the HALO principle. Some examples of how the HALO
principle can be used:
Health: the person to be vaccinated has a medical condition(s) that places
them at increased risk of acquiring a particular vaccine-preventable disease
or experiencing complications from that disease, for example, influenza.
Age: older age groups may require extra vaccines, such as influenza or
pneumococcal vaccination, or certain age groups may be targeted for
immunisation against a particular vaccine-preventable disease, such as HPV.
Another example is young to middle-aged adults who may have missed out
on vaccine doses due to schedule changes, such as the 2nd dose of MMR
vaccine.
Lifestyle: the person may have missed vaccines because they moved location
of residence, may require extra vaccines because they travel frequently, or
have other lifestyle risk factors that increase their risk of acquiring a vaccinepreventable disease, for example, smoking or injecting drugs.
Occupation: the person may be employed in an occupation for which certain
vaccines are recommended because of the increased risk of acquiring a
vaccine-preventable disease and/or transmitting it to others, such as in
healthcare or early childhood education and care.
The HALO principle is also incorporated, to some extent, into questions used in
the pre-vaccination screening checklist (see Tables 2.1.1 and 2.1.2).
2.1 PRE-VACCINATION
Catch-up vaccination for adults can be less straightforward than for children and
adolescents. A useful principle to consider when planning which vaccines to give
to adults is the HALO principle, which allows for assessment of vaccines needed
depending on risk factors:
Table 2.1.12 contains information on vaccine doses and intervals between doses
for persons aged 10 years in whom catch-up vaccination is required. This table
only contains information on vaccines that are recommended at a population
level, and for which catch-up is required if doses have been missed earlier in
life. The table does not include information on all vaccines required for adults.
Recommended vaccines and catch-up vaccination that might be required when
assessed using the HALO principle above and/or by using the pre-vaccination
screening checklist (see Tables 2.1.1 and 2.1.2) are discussed in 3.3 Groups with
special vaccination requirements.
Table 2.1.12 can be used as follows:
determine how many doses of a particular vaccine a person should have
received to be considered completely vaccinated (see Doses required
column)
deduct any previous doses of the vaccine from the number in the Doses
required column
check the appropriate Minimum interval column to schedule further doses
refer to the relevant disease-specific chapter(s) in Part 4, 3.1 Vaccination for
Aboriginal and Torres Strait Islander people, 3.2 Vaccination for international
travel, and 3.3 Groups with special vaccination requirements, for additional
recommendations, as required.
For example, a 32-year-old woman (Age) is returning to nursing (Occupation)
but has only ever had 1 dose of hepatitis B vaccine, 4 doses of the oral
poliomyelitis vaccine, 1 dose of MMR vaccine and 2 doses of DTPw vaccine as a
child and recently had a splenectomy (Health) following an accident. This person
would require:
1 dose of dTpa
2 adult doses of hepatitis B; 1 dose given now and a further dose in 2 months
no further doses of poliomyelitis vaccine (is fully vaccinated against
poliomyelitis)
1 dose of MMR vaccine
2 doses of varicella vaccine if non-immune; 1 dose given now and a further
dose in 4 weeks
1 dose of influenza vaccine, and 1 dose annually thereafter
pneumococcal vaccine: 1 dose of 13vPCV, followed by 23vPPV approximately
2 months later (because of splenectomy)
1 dose of Hib vaccine (because of splenectomy)
2 doses of 4vMenCV; 1 dose given now and a further dose in 8 weeks
(because of splenectomy).
For additional details on these recommendations, see 3.3.7 Vaccination of persons

at occupational risk; Persons with functional or anatomical asplenia in 3.3.3
Vaccination of immunocompromised persons, and relevant disease-specific chapters
in Part 4.
Where several vaccines are required for an adolescent or adult for example,
dTpa, hepatitis B and poliomyelitis vaccines childhood combination vaccines
(recommended for use in those <10 years of age) should not be used as their
antigen content differs and there may be an increased risk of adverse event(s),
such as injection site reactions. The childhood combination vaccines are not registered
for use in children aged 10 years, adolescents or adults.
Vaccine
dT (dTpa*)
Doses
required
Minimum
interval
between
dose 1 and 2
Minimum
interval
between
dose 2 and 3
3 doses
4 weeks
4 weeks
Hepatitis B
Aged 1019
years
3 paediatric
doses
1 month
2 months
Hepatitis B
Aged 1115
years only
2 adult doses
4 months
Not required
Hepatitis B
Aged 20 years
3 adult doses
1 month
2 months
Poliomyelitis (IPV)
3 doses
4 weeks
4 weeks
3 doses
4 weeks
12 weeks
MMR
2 doses
4 weeks
Not required
MenCCV
1 dose
Not required
Not required
Pneumococcal (13vPCV and

23vPPV)
Depends on age of person, Indigenous status

and if they have medical condition(s) associated
with an increased risk of invasive pneumococcal
disease (see Table 4.13.3 in 4.13 Pneumococcal
disease, and 3.3 Groups with special vaccination
requirements)
Varicella vaccine
At least
1 dose if aged
<14 years
If 2nd dose
given, a
4-week
interval is
required
Not required
2 doses if aged
14 years
4 weeks
Not required
2.1 PRE-VACCINATION
Table 2.1.12: C
atch-up schedule for persons 10 years of age (for vaccines
recommended on a population level)
Vaccine
Doses
required
Minimum
interval
between
dose 1 and 2
Minimum
interval
between
dose 2 and 3
Zoster vaccine
1 dose if aged
60 years
Not required
Not required
* One of the doses should be given as dTpa (or dTpa-IPV if poliomyelitis vaccination is also
needed) and the course completed with dT. In the unlikely event that dT is not available, dTpa or
dTpa-IPV may be used for all 3 primary doses but this is not routinely recommended as there are no
data on the safety, immunogenicity or efficacy of dTpa for primary vaccination (see also 4.12 Pertussis).
For hepatitis B vaccine, the minimum interval between dose 1 and dose 3 is 4 months (see 4.5
Hepatitis B).
4vMenCV is indicated for those at increased risk of meningococcal disease; see recommendations
in 4.10 Meningococcal disease and 3.3 Groups with special vaccination requirements).
Varicella vaccine is recommended for all non-immune persons. At least 1 dose should be given
to those aged <14 years, and all persons aged 14 years should receive 2 doses. (See also 4.22
Varicella.)
MMRV is suitable to provide varicella vaccination in children aged <14 years. This vaccine is not
recommended for use in persons 14 years of age. (See also 4.22 Varicella.)
References
2.2 ADMINISTRATION OF VACCINES

2.2.1 Occupational health and safety issues
Standard occupational health and safety guidelines should always be followed
during a vaccination. This will minimise the risk of needle-stick injury.1
Work practices should include the use of standard infection control precautions
to minimise exposure to blood and body fluids (refer to National Health and
Medical Research Councils Australian guidelines for the prevention and control
of infection in healthcare).1 If exposure does occur, guidelines for post-exposure
prophylaxis should be followed. Gloves are not routinely recommended for
immunisation service providers, unless the person administering the vaccine is
likely to come into contact with body fluids or has open lesions on the hands.
2.2.2 Equipment for vaccination

Preparing for vaccination
Depending on the vaccine(s) that are to be administered, and the age and size of
the person to be vaccinated, decide on the appropriate injection site and route,
and the injection equipment required (e.g. syringe size, needle length and gauge).
The equipment chosen will vary depending on whether the vaccine is a
reconstituted vaccine, a vaccine from an ampoule or vial, or a vaccine in a prefilled syringe.
Equipment may include:
medical waste (sharps) container
vaccine, plus diluent if reconstitution is required
2 or 3 mL syringe (unless vaccine is in pre-filled syringe)
appropriate drawing-up needle (19 or 21 gauge needle if required, to draw
up through rubber bung and for reconstitution of vaccine)
appropriate injecting needle (see Table 2.2.2 Recommended needle size, length
and angle for administering vaccines)
clean cotton wool and hypoallergenic tape to apply to injection site after
vaccination
a rattle or noisy toy for distraction after the injection.
2.2 ADMINISTRATION
OF VACCINES
A new, sterile, disposable syringe and needle must be used for each injection.
Disposable needles and syringes must be discarded into a clearly labelled,
puncture-proof, spill-proof container that meets Australian standards in order to
prevent needle-stick injury or re-use.1 Always keep sharps containers out of the
reach of children. All immunisation service providers should be familiar with the
handling and disposal of sharps according to the National Health and Medical
Research Councils Australian guidelines for the prevention and control of infection in
healthcare.1
Preparing the vaccine

Ensure that the minimum/maximum thermometer displays temperatures
within the +2C to +8C range before removing vaccine from the refrigerator.
Ensure that the correct vaccine is taken from the refrigerator and that it is
within the expiry date.
Check that there is no particulate matter or colour change in the vaccine.
Ensure that the diluent container is not damaged and potentially
contaminated.
Wash hands with soap and water or use a waterless alcohol-based hand rub.2
Prepare the appropriate injection equipment for the vaccine to be
administered.
Injectable vaccines that do not require reconstitution
If the vaccine is in a vial, remove the cap carefully to maintain sterility of the
rubber bung. There is no need to wipe the rubber bung of single-dose vials
with an alcohol swab if it is visibly clean. If there is visible contamination, the
bung should be cleaned with a single-use swab, allowing time to dry before
drawing up the contents.3
Use a 19 or 21 gauge needle to draw up the recommended dose through the
bung (or through the top of the ampoule), if required.
Change the needle after drawing up from a vial with a rubber bung or
ampoule, before giving the injection. If using a safety needle system, once
the vaccine has been drawn up, draw back on the syringe to ensure as much
vaccine as possible is removed from the tip of the needle, and then eliminate
any air to the tip of the syringe without re-priming the needle.
Injectable vaccines that require reconstitution
Reconstitute the vaccine as needed immediately before administration.

Use a sterile 21 gauge needle for reconstitution and a separate 23 or 25
gauge needle, 25 mm in length, for administration of the vaccine in most
circumstances.
Use only the diluent supplied with the vaccine; do not use sterile water for
injection instead of a supplied diluent. Ensure that the diluent and vaccine
are completely mixed.4
Check reconstituted vaccines for signs of deterioration, such as a change in
colour or clarity.
Administer reconstituted vaccines as soon as practicable after they have been
reconstituted as they may deteriorate rapidly. Refer to individual vaccine
product information for recommended times from vaccine reconstitution to
administration.
Never freeze a vaccine after it has been reconstituted.

For all injectable vaccines
Do not extrude small air bubbles through the needle for injection. However,
in the rare instance of a large air bubble in a pre-filled syringe, first draw back
on the needle to ensure no vaccine is expelled along with the air, and then
expel the air through the needle, taking care not to prime the needle with any
of the vaccine, as this can lead to increased local reaction.
Never mix other vaccines together in the one syringe (unless that is the
manufacturers registered recommendation, e.g. Infanrix hexa).4
Never mix a local anaesthetic with a vaccine.4
Vaccines in multi-dose vials
However, where mass vaccination of a population is required, such as during the

20092010 H1N1 influenza pandemic, multi-dose vials have some advantages
over single-dose vaccines. The production of vaccines in multi-dose vials is more
cost effective and can also mean that the vaccine takes less time to manufacture.
Multi-dose vials also take up less storage room in a vaccine fridge.5
The primary risk with use of multi-dose vials is a breach in infection control
through user error, for example, an unsterile needle is inserted into the vial
or a contaminated syringe is re-used. It is recognised that there are multiple
reports of instances of transmission of bacteria or blood-borne viruses through
inappropriate use of multi-dose vials; however, the majority of these have been in
high-risk settings such as haemodialysis units or with use of anaesthetics and did
not involve immunisations.
2.2.3 Route of administration

Most vaccines available in Australia are given intramuscularly. Only a few
vaccines are given subcutaneously, orally or intradermally.
Rotavirus vaccines are only available for oral administration and must never
be injected.
Special training is required for intradermal administration, which is important
for several vaccines (see 4.15 Q fever and 4.20 Tuberculosis).
Table 2.2.1 summarises the route of administration for vaccines used in Australia.
2.2 ADMINISTRATION
OF VACCINES
Multi-dose vials are not routinely used in Australia. The current exception
is bacille Calmette-Gurin (BCG) vaccine (see 4.20 Tuberculosis). Single-dose
preparations are now available for all other vaccines currently on the NIP.
Typhoid Vi polysaccharide
vaccine
13-valent pneumococcal
conjugate vaccine (13vPCV)
conjugate vaccine (10vPCV)
Japanese encephalitis vaccine

(JEspect)
IPV-containing combination
vaccines*
Human papillomavirus (HPV)

vaccine

(Hib) vaccine
Hepatitis B vaccine and Hepatitis

B combination vaccines
Hepatitis A vaccine and

Hepatitis A combination
vaccines
DTPa- and dTpa-combination

vaccines
Zoster vaccine
Measles-mumps-rubellavaricella vaccine (MMRV)

(ProQuad only)
Measles-mumps-rubella
vaccine (MMR) (M-M-R II
only)
Q fever vaccine
Japanese encephalitis vaccine

(Imojev)
Quadrivalent meningococcal
polysaccharide vaccine
(4vMenPV)
Inactivated poliomyelitis
vaccine (IPV)*
Diphtheria-tetanus vaccine (dT)
Diphtheria-tetanus-acellular
pertussis vaccine (DTPa and
dTpa)
Subcutaneous (SC) injection
Intramuscular (IM) injection
Yellow fever vaccine
Rabies vaccine (HDCV)
polysaccharide vaccine
(23vPPV)
Measles-mumps-rubellavaricella vaccine (MMRV)

(Priorix-tetra only)
Measles-mumps-rubella
vaccine (MMR) (Priorix only)
Influenza vaccine
IM or SC injection
Table 2.2.1: Route of administration for vaccines used in Australia
Q fever skin testing
Typhoid vaccine
Cholera vaccine
Rotavirus vaccine
Influenza vaccine
(Intanza only)
Bacille Calmette-Gurin
(BCG) vaccine
Oral
Intradermal
IM or SC injection
Intradermal
Q fever skin testing and BCG vaccine should be administered only by specially trained immunisation service providers.
The IM route is preferred to the SC route because it causes fewer local adverse events.6,7
* IPV-containing combination vaccines are administered by IM injection; IPV (IPOL) is administered by SC injection.
Rabies vaccine (PCECV)
Quadrivalent meningococcal
conjugate vaccine (4vMenCV)
Meningococcal C conjugate
vaccine (MenCCV)
2.2 ADMINISTRATION
OF VACCINES
Oral
2.2.4 Preparation for vaccine administration

Skin cleaning
Provided the skin is visibly clean, there is no need to wipe it with an antiseptic
(e.g. alcohol wipe).3,8 If the immunisation service provider decides to clean the
skin, or if the skin is visibly not clean, alcohol and other disinfecting agents must
be allowed to dry before vaccine injection (to prevent inactivation of live vaccines
and to reduce the likelihood of irritation at the injection site).9
Distraction techniques
The routine use of distraction, relaxation and other measures have been shown to
reduce distress and pain following vaccination in young children.10-13 Reducing
childrens distress may enhance parents timely attendance for subsequent
vaccinations.
Distraction measures that may decrease discomfort following vaccination in
young children include:10-13
swaddling and holding the infant securely (but not excessively)
shaking a noisy toy (for infants and very young children)
playing music
encouraging an older child to pretend to blow away the pain using a
windmill toy or bubbles
breastfeeding the infant during administration of the vaccine.
Discomfort may also be decreased by administering sweet-tasting fluid orally
immediately before the injection (with parental consent). In infants, 1525%
sucrose drops have been used.14
Topical anaesthetic agents, including vapocoolant sprays, are available but, to
be effective, must be applied at the correct time before vaccine administration.
Topical anaesthetics, such as EMLA, are not recommended for routine use, but
could be considered in a child with excessive fear or dislike of needles; they
require application 30 to 60 minutes before an injection.15
Vapocoolant sprays are applied 15 seconds before vaccination. These sprays have
been shown to be more effective in adults than children as children can perceive
coldness as painful and spray application may also focus the child more on the
procedure. Topical lignocaine/prilocaine is not recommended for children
<6 months of age due to the risk of methaemoglobinaemia.10
2.2.5 Vaccine injection techniques

Intramuscular injection technique16,17
For intramuscular (IM) injection, use a 25 mm needle in most cases
(see Table 2.2.2).
Depending on the injection site, position the limb so as to relax the muscle
into which the vaccine is to be injected.
Pierce the skin at an angle of 90 to the skin, so the needle can be safely
inserted to the hub.18 Provided an injection angle of >70 is used, the needle
should reach the muscle layer.19
If you have drawn back on the syringe plunger before injecting a vaccine
(which is not considered necessary),10 and a flash of blood appears in the
needle hub, withdraw the needle and select a new site for injection.20
Studies have demonstrated that, for most vaccines, local adverse events
are minimised and immunogenicity is enhanced by ensuring vaccine is
deposited into the muscle and not into the subcutaneous layer.10,21-24 However,
some vaccines (e.g. inactivated poliomyelitis, varicella and meningococcal
polysaccharide vaccines) are only registered for SC administration (see Table
2.2.1).
In the instance where a vaccine that is registered for administration only via
the IM route is inadvertently administered via the SC route, check the vaccine
product information and the Vaccines section in relevant disease-specific
chapters in Part 4 for additional information. Some vaccines may still be
immunogenic when given via the SC route, and as such, would not need to
be repeated. One vaccine that should be considered invalid and that therefore
needs to be repeated is Rabipur Inactivated Rabies Virus Vaccine (PCECV) (see
4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)). In general,
hepatitis B vaccines should also be repeated if inadvertently given SC. However,
in special circumstances, for example, in persons with bleeding disorders, some
hepatitis B vaccines may be given via the SC route (see 3.3.5 Vaccination of persons
with bleeding disorders).
A clinical trial demonstrated that for infant vaccination long (25 mm) needles
(with the skin stretched flat and the needle inserted at 90) were associated
with significantly fewer local adverse events, while achieving comparable
immunogenicity. Little difference in local adverse events or immune response
was found between needles of the same length but with different gauges.18
2.2 ADMINISTRATION
OF VACCINES
If using a 25 gauge needle for an IM vaccination, ensure the vaccine is

injected slowly over a count of 5 seconds to avoid injection pain and muscle
trauma (see Table 2.2.2).
Subcutaneous injection technique

For subcutaneous (SC) injection, administer the injection at a 45 angle to the
skin. The standard needle for administering vaccines by SC injection is a 25 or 26
gauge needle, 16 mm in length.
The immune response to vaccines inadvertently given IM rather than SC is
unlikely to be affected. Therefore it is usually not necessary to repeat doses in this
instance.
Intradermal injection technique

For intradermal injection of BCG vaccine or Q fever skin test, a 26 or 27 gauge,
10 mm needle is recommended. The intradermal injection technique requires
special training, and should be performed only by a trained provider (see 4.20
Tuberculosis and 4.15 Q fever).
One brand of influenza vaccine (Intanza) is administered via the intradermal
route. This vaccine is presented with a specifically designed needle and
syringe called the Micro-Injection System and will deliver the 0.1mL dose of
vaccine into the dermal layer of the skin without the need for special training.
Manufacturers instructions in the product packaging should be followed for
correct administration.
Table 2.2.2: R
ecommended needle size, length and angle for administering
vaccines10,16,18,21,25
Age or size of child/adult
Needle type
Angle of needle
insertion
Infant, child or adult for IM vaccines
23 or 25 gauge,* 25 mm
in length
90 to skin plane
Preterm babies (<37 weeks gestation)

up to 2 months of age; and/or very
small infants
23 or 25 gauge,* 16 mm
in length
90 to skin plane
Very large or obese patient
23 or 25 gauge, 38 mm
in length
90 to skin plane
Subcutaneous injection in all persons
25 or 26 gauge, 16 mm
in length
45 to skin plane
* If using a narrow 25 gauge needle for an IM vaccination, ensure vaccine is injected slowly over a
count of 5 seconds to avoid injection pain and muscle trauma.
The use of short needles for administering IM vaccines may lead to inadvertent SC injection and
increase the risk of significant local adverse events, particularly with aluminium-adjuvanted
vaccines (e.g. hepatitis B, DTPa, DTPa-combination or dT vaccines).
Interruption to a vaccination
If the process of administration of a vaccine given parenterally (IM or SC) is
interrupted (e.g. by syringeneedle disconnection) and most of the dose has not
been administered, the whole dose should be repeated as soon as practicable.
If most of an oral rotavirus vaccine dose has been spat out or vomited within
minutes of administration, a single repeat dose can be administered during
the same visit. If an infant regurgitates or vomits only a small part of a dose
of oral rotavirus vaccine, it is not necessary to repeat the dose. Therefore, the
regurgitated (and incomplete volume) dose is still considered as the valid dose
(see 4.17 Rotavirus).
2.2.6 Recommended injection sites
Infants <12 months of age

The vastus lateralis muscle in the anterolateral thigh is the recommended site for
IM vaccination in infants <12 months of age, due to its larger muscle size (see
Figures 2.2.5 and 2.2.6 in 2.2.8 Identifying the injection site).
The ventrogluteal area (see Figure 2.2.7 in 2.2.8 Identifying the injection site) is
an alternative site for IM vaccination of infants. It is important that vaccine
providers who choose to use this site are familiar with the landmarks used to
identify it. The reactogenicity and immunogenicity of vaccines given in this site
are comparable to those of vaccines given in the anterolateral thigh.26-28
The deltoid muscle is not recommended for IM vaccination of infants
<12 months of age.
Children 12 months of age

The deltoid muscle is the recommended site for IM vaccination in children
12 months of age (see Figure 2.2.8 in 2.2.8 Identifying the injection site).
The ventrogluteal area is an alternative site for IM vaccination of children
12 months of age (see Figure 2.2.7 in 2.2.8 Identifying the injection site).
However, vaccine providers should be familiar with the landmarks used to
identify this site.
The vastus lateralis in the anterolateral thigh may also be used in children
12 months of age (see Figures 2.2.5 and 2.2.6 in 2.2.8 Identifying the injection site),
2.2 ADMINISTRATION
OF VACCINES
The choice of injection sites depends primarily on the age of the person to be
vaccinated. The two anatomical sites recommended as routine injection sites are
the anterolateral thigh (Figures 2.2.5 and 2.2.6) and the deltoid muscle (Figure
2.2.8). Immunisation service providers should ensure that they are familiar
with the landmarks used to identify any anatomical sites used for vaccination.
Photographs and diagrams are provided in this section, but are not a substitute
for training. Further detail on identifying the recommended injection sites is
provided in 2.2.8 Identifying the injection site.
but, if this site is used, the less locally reactogenic vaccines (e.g. MMR) should be
given in the thigh.
Children with congenital limb malformation or children in spica casts

Children with congenital limb malformation(s) should receive their vaccines in
an unaffected limb where possible. The ventrogluteal area can also be considered
(see Figure 2.2.7 in 2.2.8 Identifying the injection site).29
Administration of vaccines to children in spica casts can be timed to occur when
the cast is being changed. Parents should be informed of the importance of looking
for any signs of swelling that may compromise circulation and, if this occurs,
to seek advice from their physiotherapist or doctor as soon as possible.29 Some
resources suggest the use of the deltoid muscle as an alternative route for children
in spica casts. If using this site, it is important to be aware of the radial nerve,
which is located superficially near the deltoid in children <12 months of age.
Precaution:
Vaccine injections should not be given in the dorsogluteal site or
upper outer quadrant of the buttock because of the possibility of a
suboptimal immune response.30,31 Immunoglobulin can be administered
intramuscularly into the upper outer quadrant of the buttock, but care
must be taken to ensure that the other quadrants are not used.
Adolescents and adults

The deltoid muscle is the recommended site for IM vaccination in adolescents
and adults (see Figure 2.2.8 in 2.2.8 Identifying the injection site).
The anterolateral thigh can also be used in older children and adults (see Figure
2.2.5 in 2.2.8 Identifying the injection site). However, it is important to administer
the least reactogenic vaccine in this muscle to decrease the likelihood of local
injection site reactions.
The ventrogluteal area is an alternative injection site (see Figure 2.2.7 in 2.2.8
Identifying the injection site). However, vaccine providers should be familiar with
the landmarks used to identify this site.
Patients undergoing treatment for breast cancer or patients with lymphoedema

It has been routine practice for many years to avoid giving injections, including
vaccination, into a persons arm(s) affected by lymphoedema.32-34 This
recommendation is based on the potential for arm swelling related to vaccination
to lead to, or exacerbate, lymphoedema, although there is limited evidence to
support this. Where possible, use an alternative site, such as the other arm or
thigh.32-34 For further information about vaccination of persons undergoing cancer
treatment, see 3.3 Groups with special vaccination requirements.
2.2.7 Positioning for vaccination

It is important that infants and children do not move during injection of vaccines.
However, excessive restraint can increase their fear and result in increased
muscle tension. The following section describes a variety of positions that may be
used for vaccinating different age groups.

Cuddle position for infants
Figure 2.2.1: Positioning a child <12 months of age in the cuddle position
Photo courtesy Dr Joanne Molloy, Victoria
2.2 ADMINISTRATION
OF VACCINES
Position the infant in a semi-recumbent cuddle position on the lap of the parent/
carer (see Figure 2.2.1). The infants inside arm adjacent to the parent/carer
should be restrained underneath the parent/carers arm or against the parent/
carers chest. The infants outside arm must also be held securely. The parent/
carers hand should restrain the infants outside leg and the knee should be
flexed to encourage relaxation of the vastus lateralis for IM vaccinations. This
position can also be used for young children.
Positioning an infant on an examination table
An alternative is to lay an infant on his/her back on an examination table, with

the infants feet towards the immunisation service provider, and the parent/carer
beside the provider to immobilise and distract the baby (see Figure 2.2.2).
Keep the infants hip and knee flexed by cupping the patella in the non-injecting
hand.
The thumb and index finger of the non-injecting hand may be used to stabilise
the hub of the needle once the needle has been inserted.
Although the exact mechanism is unclear, recent studies have shown that placing
a child in the supine position may result in more pain than if the child is held in
an upright position.15
Figure 2.2.2: Positioning an infant on an examination table for vaccination
Photo courtesy Dr Joanne Molloy, Victoria
Prone position across the lap for ventrogluteal vaccination
For ventrogluteal injection, position the child face-down across the parent/
carers lap (see Figure 2.2.7 below). This allows the hips to be flexed and provides
access to the ventrogluteal area.
Children 12 months of age

Cuddle position for an older child
Sit the child sideways on the lap of the parent/carer, with the arm to be injected
held close to the childs body while the other arm is tucked under the armpit and
behind the back of the parent/carer.
The childs exposed arm should be secured at the elbow by the parent/carer, and
the childs legs should also be secured by the parent/carer (see Figure 2.2.3).
Figure 2.2.3: Positioning an older child in the cuddle position
2.2 ADMINISTRATION
OF VACCINES
Photo courtesy CHW Photography
Straddle position
An older child may be positioned facing the parent/carer with the legs straddled
over the parent/carers lap. The childs arms should be folded in front, with the
parent/carer hugging the childs body to the parent/carers chest. Alternatively
the child may be positioned to hug the parent/carer with the parent/carers
arms holding the childs arms in a reciprocal hug (see Figure 2.2.4). This position
allows access to both deltoids and both anterolateral thighs.
Figure 2.2.4: Positioning a child in the straddle position
Photo courtesy CHW photography
Prone position across the lap for ventrogluteal vaccination
For ventrogluteal injection, position the child face-down across the parent/
carers lap (see Figure 2.2.7 below).
Older children, adolescents and adults

Solo sitting position for deltoid injections
Most vaccines can be administered into the deltoid area. Adults should sit in
a straight-backed chair, feet resting flat on the floor with forearms and hands
in a relaxed position on the upper thighs. Keep the arms flexed at the elbow to
encourage the deltoid muscle to relax.
Encourage the shoulders to drop by asking the person to raise the shoulders
up while taking a deep breath in and to drop them while breathing out fairly
forcefully. Use distraction to keep muscles relaxed during the procedure, for
example, have an interesting poster or similar for the person to concentrate on
during the procedure and ask him/her to give you a detailed description of what
can be seen.
The ventrogluteal and vastus lateralis are alternative sites if needed (see 2.2.6
Recommended injection sites and 2.2.8 Identifying the injection site).
2.2.8 Identifying the injection site

The choice of injection site depends on the age of the person to be vaccinated,
and is discussed in 2.2.6 Recommended injection sites.
The anterolateral thigh (vastus lateralis)

Make sure the infants nappy is undone to ensure the injection site is
completely exposed and the anatomical markers can be easily identified by
sight and palpation.
Position the leg so that the hip and knee are flexed and the vastus lateralis is
relaxed (see Figure 2.2.6).
Draw an imaginary line between the two markers down the front of the
thigh. The correct site for IM vaccination is lateral to the midpoint of this line,
in the outer (anterolateral) aspect (see Figures 2.2.5 and 2.2.6).
Do not inject into the anterior aspect of the thigh where neurovascular
structures can be damaged.
Figure 2.2.5Anatomical markers used to identify the vastus lateralis injection
site (X) on the anterolateral thigh
Anterior superior
iliac spine
Tensor fascia lata
Pubic tubercle
Level of greater
trochanter
Femoral artery
and vein
Injection site
Sartorius
Rectus femoris
llio-tibial tract
Level of lateral
femoral condyle
Vastus lateralis
Patella
2.2 ADMINISTRATION
OF VACCINES
Identify the following anatomical markers: the upper marker is the midpoint
between the anterior superior iliac spine and the pubic tubercle, and the
lower marker is the upper part of the patella.
Figure 2.2.6: The vastus lateralis injection site (X) on the anterolateral thigh
Photo courtesy Lloyd Ellis, The Royal Childrens Hospital, Victoria
The ventrogluteal area

Note: This area should not be confused with the dorsogluteal area (buttock).
The ventrogluteal area provides an alternative site for administering vaccines
to a child of any age, especially when multiple injections at the same visit are
required. The ventrogluteal area is relatively free of major nerves and blood
vessels, and the area provides the greatest thickness of gluteal muscle.35,36 There is
a relatively consistent thinness of subcutaneous tissue over the injection site.36,37
Make sure the childs nappy is undone to ensure the injection site is
completely exposed and the anatomical markers can be easily identified by
sight and palpation. Anatomical markers are the anterior superior iliac spine
(ASIS), the greater trochanter of the femur and the iliac crest (see Figure
2.2.7).
Place the child in a prone position (face-down) on the parent/carers lap
or on the clinic table/bed, with the childs arms tucked against their chest.
Allow the childs legs to dangle towards the floor (see Figure 2.2.7).
Ensure the knee and hip are turned inwards to encourage muscle relaxation
at the injection site.
Use the injection site that is closest to you.
Place the palm over the greater trochanter (the uppermost bony prominence
of the thigh bone), with the thumb pointing towards the umbilicus. Point
the index finger towards the anterior superior iliac spine, and spread the
middle finger so it aims at the iliac crest, thus creating a V outlining the
ventrogluteal triangular area. The injection site is at the centre of this area as
shown in the diagram in Figure 2.2.7.
Note: In small children and infants, the placement of the hand in relation
to these anatomical markers may vary, as shown in the photograph in
Figure 2.2.7.
Figure 2.2.7: Anatomical markers used to identify the ventrogluteal injection
site (X)
2.2 ADMINISTRATION
OF VACCINES
ASIS = anterior superior iliac spine
Photo courtesy of Dr Joanne Molloy, Victoria
The deltoid area

To locate the deltoid site for injection:
Expose the arm completely, from the top of the shoulder to the elbow; roll up
the sleeve or remove the shirt if needed.
Locate the shoulder tip (acromion) and the muscle insertion at the middle of
the humerus (deltoid tuberosity).
Draw an imaginary inverted triangle below the shoulder tip, using the
identified anatomical markers (see Figure 2.2.8).
The deltoid site for injection is halfway between the acromion and the deltoid
tuberosity, in the middle of the muscle (triangle).
Figure 2.2.8: Anatomical markers used to identify the deltoid injection site
Subcutaneous injection sites

Subcutaneous injections should be administered either over the deltoid muscle
or over the anterolateral thigh. There are no studies that describe any specific
differences in the technique used for an SC injection compared with a deep
SC injection. Figure 2.2.9 demonstrates the recommended technique for any SC
injection.
Figure 2.2.9: A subcutaneous injection into the deltoid area of the upper arm
using a 25 gauge, 16 mm needle, inserted at a 45 angle
Photo courtesy Jane Jelfs NCIRS
2.2.9 Administering multiple vaccine injections at the same visit

When sequentially administering multiple vaccines to children, give the most
painful vaccine last (e.g. pneumococcal conjugate vaccine). Evidence suggests
that this may decrease the overall pain response.
The location of each separate injection given should be recorded, so that if a local
adverse event occurs, the implicated vaccine(s) can be identified.

The suitable sites for this age group are the anterolateral thighs (preferred) and
the ventrogluteal areas. For the routine schedule where only two vaccines are
required, one can be given in each thigh.
two injections in the same anterolateral thigh, separated by at least 2.5 cm

(see Figure 2.2.10, injection numbers 1 and 2); further IM vaccines can be
given in this way in the other thigh (injection number 3), or
one injection into each anterolateral thigh and one injection into each
ventrogluteal area (only one injection should be given into each
ventrogluteal area).
Figure 2.2.10: Recommended technique for giving multiple vaccine injections
into the anterolateral thigh in an infant <12 months of age
Children 12 months of age, adolescents and adults

A single injection can be given into each deltoid muscle.
When three or four IM vaccines are to be given to a child at the same visit, the
options will depend on the muscle mass of the childs deltoid.
If the deltoid mass is adequate, give a further injection into each deltoid
muscle (separated by 2.5 cm from the initial injection site).
2.2 ADMINISTRATION
OF VACCINES
When three or four injectable vaccines are to be given at the same visit, the
options are:
If the deltoid muscle mass is small:

give further injections into either anterolateral thigh (2.5 cm apart if two
vaccines are given in the same thigh), or
give one injection into each ventrogluteal area.
For younger children, the cuddle or straddle positions (Figures 2.2.3 and 2.2.4)
are suitable for accessing multiple limbs during the one vaccination encounter.
Simultaneous injections by two immunisation providers

Currently there is insufficient evidence for or against having two immunisation
providers administer vaccines at the same time rather than one vaccine after the
other.38,39 Two studies were unable to demonstrate a difference in pain response in
the child between simultaneous administration and sequential administration.38,39
If multiple immunisation providers are available, the technique has been
explained to the parent and the parent gives consent, then the vaccines may be
administered simultaneously, providing different sites can be safely accessed.
References
2.3 POST-VACCINATION
2.3.1 Immediate after-care
Immediately after vaccine administration:
dispose of clinical waste, including sharps and vaccine vials, at the point of
use (refer to state/territory health authorities for management guidelines for
the safe disposal of clinical waste or refer to the National Health and Medical
Research Councils Australian guidelines for the prevention and control of infection
in healthcare)1
cover the injection site quickly with a dry cotton ball and tape as needed
to distract the vaccinated person and reduce distress, immediately change the
position of the child/person after completing the vaccination, for example,
ask the parent/carer to put the infant over his/her shoulder and move
around with the infant2
remove the cotton wool after a few minutes and leave the injection site
exposed to the air
record the relevant details of the vaccines given (see 2.3.3 Documentation of
vaccination).
The vaccinated person and/or parent/carer should be advised to remain in the
vicinity for a minimum of 15 minutes after the vaccination. The area should be
close enough to the immunisation service provider so that the vaccinated person
can be observed and medical treatment provided rapidly if needed.
Paracetamol is not routinely used before, or at the time of, vaccination, but may
be recommended as required for fever or pain occurring following immunisation.
Before departure, inform the vaccinated person or parent/carer, preferably in
writing, of any expected adverse events following immunisation, and of the date
of the next scheduled vaccination(s).
Take the opportunity to check the vaccination status of other family members
(as appropriate) and discuss any catch-up vaccination requirements and options
available (this can also be done earlier in the visit).
2.3.2 Adverse events following immunisation

What are adverse events following immunisation?
An adverse event following immunisation (AEFI) is any untoward medical
occurrence that follows immunisation and does not necessarily have a causal
relationship with the usage of the vaccine. The adverse event may be any
unfavourable or unintended sign, abnormal laboratory finding, symptom or
disease.3 Such an event may be caused by the vaccine(s) or may occur by chance
gently apply pressure for 1 or 2 minutes do not rub the site as this will
encourage the vaccine to leak back up the needle track, which can cause pain
and may lead to local irritation
(i.e. it would have occurred regardless of vaccination). Most vaccine adverse

events are minor, such as low-grade fever, and pain or redness at the injection
site; these should be anticipated.4 The frequency of adverse events has been
classified by regulatory agencies, and is often reported in clinical trials as follows:
very common (>10% of persons vaccinated), common (110%), uncommon (0.1
<1%), rare (0.01%<0.1%) and very rare (<0.01%).5 Detailed information on types
of expected common and rare adverse events is provided below.
An important factor in reducing the likelihood of an adverse event occurring
is to screen each person to be vaccinated (using the pre-vaccination screening
checklists in Tables 2.1.1 and 2.1.2) to ensure that the person does not have a
condition that either increases the risk of an AEFI or is a contraindication to
vaccination. Immunisation service providers should also check the relevant
chapters of this Handbook, including the variations from product information, and
any other relevant sources, such as state/territory guidelines. The use of correct
injection procedures is also important (see 2.2 Administration of vaccines).
Expected common AEFI are described in the table Comparison of the effects of
diseases and the side effects of NIP vaccines inside the back cover of this Handbook.
Detailed information on the adverse events that are known to occur after
vaccination is contained in the Adverse events section of each disease-specific
chapter in Part 4. Persons to be vaccinated and/or their parents/carers should
be given advice (preferably written) as part of the consent procedure on what
common or expected adverse events are likely and what they should do about
them. The table inside the front cover of this Handbook, Side effects following
immunisation for vaccines used in the National Immunisation Program (NIP) schedule,
can be used for this purpose.
Parents/patients should be encouraged to contact their healthcare provider
if they are concerned about an adverse event occurring after vaccination,
particularly if it is an unexpected, uncommon and/or serious adverse suspected
reaction to vaccination. Healthcare providers and parents/carers are encouraged
to report any untoward medical occurrence that follows immunisation,
particularly events that are serious and/or unexpected, and/or relate to a new
vaccine or condition of interest. For more detailed information on reporting
AEFI, see Reporting adverse events following immunisation below and Table
2.3.3 Contact information for notification of adverse events following immunisation. In
addition to reporting AEFI, immunisation providers should provide the patient/
parents with information and a plan of management regarding the adverse
event experienced, including the implications for subsequent vaccination. This is
discussed more in the next three sections on management of immediate, common
and rare adverse events, and also in 3.3.1 Vaccination of persons who have had an
adverse event following immunisation.
Management of an immediate adverse event following immunisation

The vaccinated person should remain under observation for a short interval
to ensure that they do not experience an immediate adverse event. It is
recommended that vaccinated persons remain in the vicinity of the place of
vaccination for at least 15 minutes. Severe anaphylactic reactions usually have
a rapid onset; life-threatening adverse events are most likely to begin within 15
minutes of vaccination.
Anaphylaxis and vasovagal episodes

Anaphylaxis following routine vaccination is very rare, but can be fatal.6 All
immunisation service providers must be able to recognise all the symptoms
and signs of anaphylaxis and distinguish between anaphylaxis, convulsions
and fainting. The features listed in Table 2.3.1 may be useful in differentiating
between fainting (vasovagal episode) and anaphylaxis.
Anaphylaxis is a severe adverse event of rapid onset, characterised by
sudden respiratory compromise and/or circulatory collapse.7 Early signs
include involvement of the skin (e.g. generalised erythema, urticaria and/or
angioedema) and/or gastrointestinal tract (e.g. diarrhoea, vomiting). In severe
cases, there is circulatory collapse with alteration in the level of consciousness,
hypotension and weak or absent pulses, and/or marked respiratory compromise
from upper airway oedema or bronchospasm.
Fainting (vasovagal episode) is relatively common after vaccination of adults and
adolescents, but infants and children rarely faint. Sudden loss of consciousness
in young children should be presumed to be anaphylaxis, particularly if a strong
central pulse is absent. A strong central pulse (e.g. carotid) persists during a faint
or convulsion.
If a diagnosis of anaphylaxis is suspected, treatment, including administration
of adrenaline, should be instituted promptly8 (see Management of anaphylaxis
below). Under-treatment of anaphylaxis is more harmful, and potentially lifethreatening, than over-treatment of a mild or moderate allergic reaction.9
The most serious immediate AEFI is anaphylaxis. However, in adults and older
children, the most common immediate adverse event is a vasovagal episode
(fainting), either immediately or soon after vaccination. Because fainting
after vaccination can lead to serious consequences, anyone who complains of
giddiness or light-headedness before or after vaccination should be advised to lie
down until free of symptoms.
Table 2.3.1: C
linical features that may assist differentiation between a
vasovagal episode and anaphylaxis
Onset
Symptoms/
Signs
Respiratory
Vasovagal
episode
Anaphylaxis*
Immediate,
usually within
minutes of, or
during, vaccine
administration
Usually within 15 minutes,

but can occur within hours, of
vaccine administration
Normal
respiration; may
be shallow, but
not laboured
Cough, wheeze, hoarseness,

stridor, or signs of respiratory
distress (e.g. tachypnoea,
cyanosis, rib recession)
Upper airway swelling (lip,
tongue, throat, uvula or larynx)
Cardiovascular
Bradycardia,
weak/absent
peripheral pulse,
strong carotid
pulse
Hypotension
usually transient
and corrects in
supine position
Loss of
consciousness
improves
once supine or
in head-down
position
Skin
Generalised
pallor, cool,
clammy skin
Tachycardia, weak/absent
carotid pulse
Hypotension sustained and
no improvement without
specific treatment (Note: in
infants and young children,
limpness and pallor are signs
of hypotension)
Loss of consciousness no
improvement once supine or in
head-down position
Pruritus (skin itchiness),

generalised skin erythema
(redness), urticaria (weals)
or angioedema (localised
or general swelling of the
deeper layers of the skin or
subcutaneous tissues)
Gastrointestinal Nausea/
vomiting
Abdominal cramps, diarrhoea,

nausea and/or vomiting
Neurological
Sense of severe anxiety and

distress
Feels faint, lightheaded
* Modified from The Brighton Collaboration Case Definition Criteria for Anaphylaxis.6
Neurological symptoms are not listed in the Brighton case definition criteria for anaphylaxis;6
however, symptoms of anxiety and distress, including feelings of impending doom, are reported
in persons experiencing anaphylaxis.7,10
Rapid IM administration of adrenaline is the cornerstone of treatment of

anaphylaxis. Adrenaline is life saving and must be used promptly.8
Anaphylaxis occurs without warning, usually within 15 minutes of giving a
vaccine. A protocol for the management of anaphylaxis, adrenaline and 1mL
syringes must always be immediately at hand whenever vaccines are given.
If the patient is unconscious, lie him/her on the left side and position to keep
the airway clear.
If the patient is conscious, lie him/her supine in head-down and feet-up
position (unless this results in breathing difficulties).

If there is no improvement in the patients condition within 5 minutes, repeat
doses of adrenaline every 5 minutes until improvement occurs.
Check breathing; if absent, commence basic life support or appropriate
cardiopulmonary resuscitation (CPR), as per the Australian Resuscitation
Council guideline12 (available at www.resus.org.au/policy/guidelines).
In all cases, transfer the person to hospital for further observation and
treatment.
Complete full documentation of the event, including the time and dose(s) of
adrenaline given.
Antihistamines and/or hydrocortisone are not recommended for the emergency
management of anaphylaxis.
Use of adrenaline
The use of 1:1000 adrenaline is recommended because it is universally available.

Adrenaline 1:1000 (one in one thousand) contains 1mg of adrenaline per mL of
solution in a 1mL glass vial. Adrenaline 1 in 10 000 is no longer recommended
for the treatment of anaphylaxis. A 1mL syringe should be used to improve the
accuracy of measurement when drawing up small doses of adrenaline.
The recommended dose of 1:1000 adrenaline is 0.01mL/kg body weight
(equivalent to 0.01mg/kg or 10g/kg) up to a maximum of 0.5mL, given by
deep IM injection preferably in the anterolateral (upper outer) thigh. The anterolateral
thigh is the preferred site because there is a more predictable dispersal of
If there are any respiratory and/or cardiovascular symptoms or signs of

anaphylaxis, give adrenaline by IM injection into the anterolateral thigh
(see Use of adrenaline below for dosage). Adrenaline is not required for
generalised non-anaphylactic reactions (such as skin rash or angioedema).
If in doubt, IM adrenaline should be given. No serious or permanent harm
is likely to occur from mistakenly administering adrenaline to an individual
who is not experiencing anaphylaxis.11
adrenaline from this site.13 Administration of adrenaline in the anterolateral

thigh is also in accordance with recommendations from various emergency
medicine, anaesthetic and immunology professional bodies.9
Adrenaline 1:1000 must not be administered intravenously.
Table 2.3.2 lists the dose of 1:1000 adrenaline to be used if the exact weight of
the person is not known.
The dose of 1:1000 (one in one thousand) adrenaline may be repeated every
5 minutes, as necessary, until there is clinical improvement.
Table 2.3.2: D
oses of intramuscular 1:1000 (one in one thousand) adrenaline for
anaphylaxis*14
Approximate age and weight
Adrenaline dose
0.050.1 mL
12 years (approx. 10 kg)
0.1 mL
0.15 mL
0.2 mL
0.3 mL
0.4 mL
0.5 mL
* Modified from insert published in Australian Prescriber14 (available at www.australianprescriber.

com/magazine/34/4/article/1210.pdf). Endorsed by the Australasian Society of Clinical
Immunology and Allergy, the Royal Australasian College of Physicians, the Royal Australian
College of General Practitioners, the Australasian College for Emergency Medicine, the Royal
Australian and New Zealand College of Radiologists, the Internal Medicine Society of Australia
and New Zealand, and the Australian Dental Association.
Use of adrenaline autoinjectors for anaphylaxis treatment
Adrenaline autoinjectors, EpiPen or Anapen, are devices that administer a single,

pre-measured dose of adrenaline. They are designed for use by any person,
whether medically trained or not. Clear instructions on correct use are provided
on the barrel and in the packaging of these devices. They are designed to be
administered in the mid-outer thigh.
Autoinjectors are usually recommended or prescribed for an individual who is
at risk of anaphylaxis due to an existing allergy or where skin testing indicates
a high risk of an allergic reaction on exposure to an allergen. If a patient who
carries an autoinjector device develops anaphylaxis post vaccination, it is
appropriate to use their autoinjector to administer adrenaline.
Autoinjectors are generally not appropriate for inclusion in first aid kits for
general use, due to several limitations:
they are single-use only
they are dose-specific
EpiPen Jr or Anapen Jr containing 150g of adrenaline are recommended
for children weighing between 10kg and 20kg
EpiPen or Anapen containing 300g of adrenaline are recommended for
children and adults weighing over 20kg
multiple pens would be required to allow for repeat dosing and varying
ages/weights of patients, and shelf-life is limited to 1 to 2 years maximum.
Autoinjectors are not recommended for use in children weighing less than 10kg.
Commonly occurring AEFI are described in the table Comparison of the effects of
diseases and the side effects of NIP vaccines inside the back cover of this Handbook
and in the disease-specific chapters in Part 4.
The most commonly encountered adverse events are local reactions related to
vaccine injection(s), such as pain, redness, itching, swelling or burning at the
injection site. These are to be expected, are generally mild and usually last for
1 to 2 days. Injection site nodules are also relatively common. They are fibrous
remnants of the bodys interaction with the vaccine components (usually an
adjuvant) in the muscle. They may remain for many weeks after vaccination and
do not require any specific treatment.
Low-grade fever and tiredness (malaise), lasting a few days, are also common
after many vaccines. These responses are usually mild and self-limiting, and
generally do not require specific treatment.
Routine use of paracetamol at the time of, or immediately after, vaccination is
not recommended. However, if an infant, child or adult has a fever of >38.5C
following vaccination or has pain at the injection site, paracetamol can be given.
The dose of paracetamol for an infant or child up to 12 years of age is
15mg/kg/dose, up to a maximum dose of 60mg/kg per day in four divided
doses. Adults and children aged 12 years can receive 500 to 1000mg every 4 to 6
hours; dosage must not exceed 4g in 24 hours. Paracetamol should not be given
for more than 48 hours without seeking medical advice.15
If patients exhibit unexpected, serious or prolonged adverse symptoms or signs
following immunisation, medical advice should be sought. The symptoms and
signs from medical illness unrelated to vaccination can sometimes be attributed
to a recent immunisation and should be investigated and managed accordingly.
Common adverse events following immunisation and their management
Uncommon/rare adverse events following immunisation

Some vaccines have been shown to cause uncommon or rare serious adverse
events, although the rate of vaccine adverse events is usually hundreds to
thousands times less frequent than the disease complications. Information on the
benefits compared with risks of immunisation is always taken into account when
making recommendations for vaccine use. It is important to provide persons
to be vaccinated or their parent/carer with advice regarding known, but rare,
adverse events following immunisation, and to place the advice in the context of
the benefits of vaccination (see 3.3.1 Vaccination of persons who have had an adverse
event following immunisation).
If a patient has experienced a serious or uncommon/rare AEFI, it is important
that they or their immunisation service provider seek advice from a specialist
immunisation clinic or contact state/territory health authorities for more
information regarding the need for further investigation and management (see
Appendix 1 Contact details for Australian, state and territory government health
authorities and communicable disease control). This will enable an assessment to
determine the relationship to vaccination, consideration of the benefits and risks
of further vaccination, and planning for receiving additional doses of that or
other vaccines, as appropriate. Persons who have had a serious adverse event
following immunisation (other than a contraindication, such as the confirmed
identity of the vaccine component that triggered anaphylaxis) can usually
subsequently be vaccinated under close medical supervision. For more detailed
information see 3.3.1 Vaccination of persons who have had an adverse event following
immunisation.
Examples of uncommon and rare adverse events are given below. It is important
to remember that, although these events are uncommon or rare, they are still
not necessarily causally related to vaccination, even if they occur following
vaccination.
Febrile convulsions are a relatively common response to fever of any cause
in young children, particularly in those aged <3 years, with a peak incidence
at 1418 months of age. Overall, by the age of 5 years, approximately 3%
of all children will have experienced a febrile convulsion, irrespective of
vaccination. Febrile convulsions are rare following immunisation. They do,
however, occur more commonly, but still at a low rate, after some vaccines.
For example, MMR and MMRV vaccines are associated with an increased
risk of febrile convulsions approximately 7 to 12 days after the 1st vaccine
dose (see 4.9 Measles for more information). Co-administration of trivalent
influenza vaccine and 13-valent pneumococcal conjugate vaccine may also be
associated with an increased risk of febrile convulsions (see 4.7 Influenza and
4.13 Pneumococcal disease). In 2010, there was an increased incidence of high
fevers and febrile convulsions (estimated at 4.4 per 1000 doses in Western
Australia) following administration of one brand of seasonal influenza
vaccine (Fluvax and Fluvax Junior, CSL Limited) in children aged <5 years in
Australia.16 This vaccine is no longer registered for use in this age group. An
excess risk of fever and febrile convulsions was not observed with the other
influenza vaccines given to children.16,17
Brachial neuritis (inflammation of a nerve in the arm, causing weakness
or numbness) has been described following the administration of tetanus
toxoid-containing vaccines, with an estimated excess risk of approximately
0.51 in 100 000 doses in adults.5,18 Case reports of brachial neuritis following
administration of other vaccines, including HPV vaccines,19 are rare and a
causal relationship has not been established.20
Anaphylaxis following receipt of vaccines has been reported, but generally

occurs very rarely.24 For example, the estimated incidence rate of anaphylaxis
following 4vHPV vaccine in Australia as at June 2010 was 2.6 anaphylaxis
episodes per million doses of vaccine distributed.25 This is within the
same rate range as for other vaccines given to children and adolescents in
international studies, such as hepatitis B vaccine, which is associated with
anaphylaxis in approximately 1 in 1.1 million doses distributed.26 (For more
information on the management of immediate AEFI/anaphylaxis, see above.)
Hypotonic-hyporesponsive episode (HHE) is the sudden onset of pallor
or cyanosis, limpness (muscle hypotonia), and reduced responsiveness
or unresponsiveness occurring after vaccination, where no other cause is
evident such as a vasovagal episode or anaphylaxis. The episode usually
occurs 1 to 48 hours after vaccination and resolves spontaneously. There are
no known long-term side effects from HHE.27,28 In Australia during 2009,
3.2 cases of HHE were reported per 100 000 doses of DTPa-containing vaccine
given to children <1 year of age.29
Guillain-Barr syndrome (GBS) is a rare autoimmune condition with acute
onset of a rapidly progressive, ascending, symmetrical flaccid paralysis, with
or without sensory loss. Diagnosis of GBS is complex and must be made
by a physician. A small increased risk of GBS was associated historically
with one influenza vaccine in the United States in 1976, but since then close
surveillance has shown that GBS has occurred at a very low rate of up to 1 in
1 million doses of influenza vaccine, if at all.30
Oral rotavirus vaccines are associated with a small increased risk of

intussusception (IS), a rare form of bowel blockage caused by telescoping
of the intestine into itself. This risk appears to be particularly in the 7 days
following the 1st vaccine dose; however, a smaller increased risk in the week
following the 2nd dose has also been reported.21-23 It is not currently clear
whether there is an overall increase in the risk of IS above that which would
be expected in the 1st year of infancy without vaccine use. The increased risk
represents approximately 6 additional cases of intussusception among every
100 000 infants vaccinated, or 14 additional cases per year in Australia.23
Children who have had IS are recommended to not receive rotavirus vaccine
(see 4.17 Rotavirus).
Events where evidence demonstrates no causal link with immunisation

Since vaccines are mainly given to healthy people, a range of conditions that
occur after a vaccine dose may be attributed to vaccination. This is particularly so
for illnesses that are complex and have an unknown or unclear cause. As many
of these illnesses are rare and/or manifest months to years after vaccination,
they are difficult to study in randomised controlled clinical trials, which are
typically conducted before vaccines are registered for use. However, there is
strong epidemiological evidence, usually derived from multiple well-conducted
post-marketing studies, that indicates there is no causal association between
immunisation and many diseases/conditions in which vaccines were suggested
to have been involved.
Examples of events unrelated to vaccination include:
sudden infant death syndrome (SIDS) and any vaccine31-33
autism and MMR vaccine34-39
multiple sclerosis and hepatitis B vaccine40-43
inflammatory bowel disease and MMR vaccine44
diabetes and Hib vaccine45-47
asthma and any vaccine.48
Despite this evidence, patients/parents seeking further advice should discuss
this with their immunisation provider or could be referred to a specialist
immunisation clinic for further reassurance (see Appendix 1 Contact details
disease control).
Reporting adverse events following immunisation

Surveillance for adverse events following immunisation is an integral part
of the Australian National Immunisation Program, and underpins the safe
use of all vaccines in Australia. Surveillance of AEFI aims to detect changes
in the rates of known adverse events, any unrecognised or unexpected
adverse events, or adverse events that result from program errors, such as
incorrect vaccine schedule, delivery or storage. It is very important that
all immunisation service providers report AEFI, particularly if serious or
unexpected, as this will enable vaccine safety issues to be identified and
managed appropriately as soon as possible. For example, reporting of AEFI by
immunisation service providers in Australia in 2010 resulted in the detection of
an unexpectedly high rate of fever and febrile convulsions in young children,
associated with the use of one brand of seasonal influenza vaccine.49,50 All
reported AEFI are included in the Adverse Drug Reactions System (ADRS)
database of the Therapeutic Goods Administration (TGA). For details on how
to report AEFI, see the next section below.
Any serious or unexpected adverse event following immunisation should

be promptly reported. Providers should use clinical judgment in deciding
which adverse events to report and parents/carers should be encouraged
to notify the immunisation service provider or health authorities of any
untoward medical occurrence that follows immunisastion.
In addition to reporting of AEFI, immunisation service providers may need

to provide additional clinical management and advice regarding future
vaccination(s) for their patient and may require expert advice. Information about
specialist immunisation clinics, or the contact details for paediatricians or medical
specialists with experience in management of patients with AEFI, are usually
available from state and territory health authorities (see Appendix 1 Contact details
disease control) and from the Immunise Australia website (www.immunise.health.
gov.au). For more information on managing common and rare AEFI,
see above and also 3.3.1 Vaccination of persons who have had an adverse event
following immunisation.
How to report adverse events following immunisation
AEFI are notifiable via different routes; immunisation service providers should
be aware of the method of reporting for their location. In most jurisdictions
(the Australian Capital Territory, New South Wales, the Northern Territory,
Queensland, South Australia, Victoria and Western Australia), AEFI should be
reported directly to the relevant state/territory health authority (see Table 2.3.3).
AEFI notified to these state and territory health departments are then forwarded
to the TGA, who manage the ADRS database, which includes all adverse reaction
reports related to drugs and vaccines. Reporting can also be done directly to the
TGA as described below.
No time limit has been set to report AEFI; however, timely notification of adverse
events, particularly rapid reporting of serious events, is important to identify any
potential concerns. Notification does not necessarily imply a causal association
with vaccination, as some events may occur coincidentally following vaccination.
Any event that is suspected of being related to vaccination can be reported.
All identifying information relating to the reporter and patient is kept strictly
confidential. Any person, medical or non-medical, including providers who did
not give the vaccine(s), can report an AEFI; however, it is very important that as
much detail as possible is provided on all reports.
Table 2.3.3: C
ontact information for notification of adverse events
following immunisation
State/Territory
Report adverse events to
Contact information
Australian Capital
Territory
ACT Health Department
02 6205 2300
New South Wales
NSW Public Health Units
1300 066 055

(for connection to Public
Health Unit)
Northern Territory
NT Department of Health
08 8922 8044
Queensland
Queensland Health
Complete an AEFI initial report

form, available at: www.health.
qld.gov.au/immunisation or by
phoning 07 3328 9888.
Fax the completed form to the
number provided on the form.
South Australia
SA Health
1300 232 272

Tasmania
Direct to the TGA
1800 044 114

or complete the Blue card
reporting form (see below)
Victoria
SAEFVIC
03 9345 4143 or online at www.

saefvic.org.au
Western Australia
State Health Department,

WAVSS
08 9321 1312 or online at wavss.

health.wa.gov.au
Alternatively, reporting directly to the TGA can be done by any person in

any jurisdiction. Reports are submitted using the Blue card adverse reaction
reporting form. Paper copies of the Blue card are available from:
Office of Product Review
Therapeutic Goods Administration
Reply Paid 100
Woden ACT 2606
Telephone: 1800 044 114
or online at www.tga.gov.au/safety/problem-medicines-forms-bluecard.htm.
Alternatively, the adverse reaction reporting form can be completed and
submitted online via the TGA website at www.ebs.tga.gov.au/ebs/ADRS/
ADRSRepo.nsf?OpenDatabase.
Consumers and immunisation service providers can also report AEFI (and
adverse drug reactions) via the national Adverse Medicines Events telephone
reporting line on 1300 134 237. This service is operated by the National
Prescribing Service (NPS) (www.nps.org.au) and funded by the Australian
Government through the Department of Health.
The TGA, in turn, forwards copies of individual reports of AEFI from vaccines
on the NIP schedule back to state/territory health departments for their
information.
Information on AEFI reports to the TGA from all sources are aggregated, and
detailed information on AEFI reporting rates and trends in AEFI are published on
a 6-monthly basis in the journal Communicable Diseases Intelligence (www.health.
gov.au/internet/main/publishing.nsf/content/cda-pubs-cdi-cdiintro.htm).24,51
It is essential that immunisation service providers ensure there is appropriate
documentation of all vaccinations given to persons of any age. There are a
number of ways in which this should be done.
All vaccines administered to children should be documented in the childs
clinical file and the individual child health record that is established for all
newborn infants. This record should be kept by the parent/carer and presented
every time the child is seen by a health professional.
Vaccines administered to adolescents and adults should be recorded in both the
vaccinated persons clinical file and the personal health record, or individual
record, of vaccination. The following details should be recorded:
the persons full name and date of birth
the details of the vaccine given, including the brand name, batch
number and dose number
the date and time of vaccination
the site of administration
the name of the person providing the vaccination
the date the next vaccination is due.
Some state/territory health departments also have specific requirements for
documentation of vaccines administered to healthcare workers/healthcare
students undertaking work or clinical placement within state/territory health
facilities. Refer to the relevant state/territory health department for further
details (see Appendix 1).
Immunisation service providers should also report vaccination details to the
appropriate immunisation register(s) discussed in detail below.
2.3.3 Documentation of vaccination
2.3.4 Immunisation registers

Australian Childhood Immunisation Register
The Australian Childhood Immunisation Register (ACIR) is a national database
for recording details of vaccinations given to children <7 years of age who live
in Australia. The ACIR commenced on 1 January 1996 and is administered
by the Department of Human Services under the legislative mandate of the
Commonwealth Health Insurance Act 1973 Part IVA. Section 46B of the Act
specifies how the ACIR is to be implemented and managed. Section 46E sets
out the provisions for giving both de-identified and identified information to
recognised immunisation service providers and other specified agencies.
Children enrolled in Medicare are automatically included on the ACIR. Children
not enrolled in Medicare will be included when an immunisation service
provider sends details of a vaccination to the ACIR. No vaccination information
is recorded on the ACIR once a child turns 7 years of age, but any information
already held is retained. The information will relate only to vaccines received
between birth and the childs 7th birthday.
The ACIR provides an important means of accountability and evaluation of the
childhood vaccination program. The ACIR is the primary means of determining
vaccination coverage at national, state/territory and local levels. It also provides
a central vaccination history for each child, which is accessible to any Australian
immunisation service provider wishing to assess vaccination status. Since 1998,
data held on the ACIR have been used to determine a familys entitlement
to the Child Care Benefit and, from July 2012, the Family Tax Benefit Part A
supplement. It is, therefore, important that immunisation service providers
submit vaccination data to the ACIR promptly.
Reporting to the Australian Childhood Immunisation Register
Immunisation service providers should send to the ACIR details of all NIP and
private vaccinations given to children <7 years of age. Vaccination details may
be submitted by sending data electronically via Medicare Online or the ACIR
secure Internet site, or by using a paper form. Immunisation service providers
in Queensland and the Northern Territory who currently send data to the
ACIR via their state/territory health department should continue to do so.
Immunisation service providers in all other states/territories should send data
directly to the ACIR.
A childs vaccination record can also be updated with vaccination details where
the vaccination was performed by another immunisation service provider,
including vaccines given while the child was overseas, by completing and
sending an Immunisation History form to the Department of Human Services.
Forms are available on the health professionals section of the Medicare Australia
website (www.medicareaustralia.gov.au/provider/pubs/forms/files/acirimmunisation-encounter-form-0911.pdf).
When relevant, immunisation service providers should complete either the

Medical Contraindication or other objection forms and forward these to
the ACIR.
For further information about the ACIR and reporting vaccination information,
see The ACIR on the Internet below. In addition, assistance on any reporting
issues can be obtained from the ACIR Enquiry Line, 1800 653 809 (free call).
The Australian Childhood Immunisation Register on the Internet
The Department of Human Services (DHS) website (www.humanservices.

gov.au/customer/services/medicare/medicare-online-services) houses ACIR
information and resources. The website has a general information area for
individuals and families, a general information area for health professionals and
a secure area for approved immunisation service providers only.
Immunisation History Statement
Immunisation History Statements contain details of all vaccines administered

to a child that are recorded on the ACIR and list the vaccines that are next due.
These Statements are automatically generated when a child turns 18 months of
age, 5 years of age, and on completion of the childhood vaccination schedule.
These Statements will be mailed to the address most recently recorded by
Medicare for that child.
Parents/carers can also get an Immunisation History Statement at any other
time:
online at www.humanservices.gov.au/customer/services/medicare/
australian-childhood-immunisation-register
from their local DHS Service Centres
by calling 1800653809 (free call).
The secure ACIR Internet site (https://www1.medicareaustralia.gov.au/ssl/

acircirssamn) allows approved immunisation service providers to obtain a range
of statistical and identified reports. Depending on the access level granted to the
provider, these reports enable approved providers to view a childs vaccination
details, record vaccination information and access a range of other reports.
All health professionals with access to Health Professional Online Services
(HPOS) can access the ACIR Internet site through this platform. In addition,
immunisation service providers can register for access to the secure ACIR
Internet site only by completing the online request form, available from the
Department of Human Services website. Further information or assistance may
be obtained by calling the ACIR Internet Helpline on 1300650039.
Immunisation History Statements can be used to assist in recalling vaccination

history when required. For example:
for school enrolment a sentence will be displayed at the bottom of the
Statement that says the child has received all the vaccinations required by
5 years of age
to determine eligibility for the Child Care Benefit and the Family Tax
Benefit Part A supplement this requires that children are assessed as
fully immunised; this replaced the Maternity Immunisation Allowance on
1July2012.
The ACIR Enquiry Line can be contacted on 1800653809 (free call) and any
record held for a person who is now 7 years of age can be made available to an
immunisation service provider or parent/carer.
Recording details of a deceased child
The ACIR should be notified of the death of a child to prevent an Immunisation

History Statement being sent to bereaved parents/carers. Advice of a childs
death can be provided to the ACIR by calling 1800653809 (free call), or by
sending details on practice stationery. Details should include the childs name,
address, date of birth, Medicare number and date of death.
Children who have moved to live overseas
A child who has moved overseas can be removed from the ACIR by sending
details to the ACIR by fax, phone or secure site email. This prevents the childs
name continuing to appear on ACIR reports of overdue children.
Children born overseas who have moved to live in Australia permanently
A child born overseas who has moved permanently to Australia will be

automatically added to the ACIR upon enrolment with Medicare. Children
residing temporarily in Australia are not included on the ACIR.
Ascertaining individual vaccination status
Parents/carers can telephone the ACIR on 1800653809 (free call) for information
about their childs vaccination status, regardless of where the childs vaccination
was given. Immunisation service providers can also request a childs vaccination
status by telephone.
Vaccination coverage and other reports
ACIR reports assess progress towards national targets, help to identify areas with
low vaccination levels, and assist in planning vaccination programs.
Practices can receive quarterly reports on vaccination coverage for children
within their practice. Other reports, including those that identify a childs
vaccinations and due/overdue details, are available through the secure area
of the ACIR Internet site (https://www1.medicareaustralia.gov.au/ssl/
acircirssamn) to approved immunisation service providers.
National Human Papillomavirus Vaccination Program Register

The National HPV Vaccination Program Register (NHVPR), also referred to
as the HPV Register, was established following the passing of the National
Health Amendment Act (National HPV Vaccination Program Register) Bill in
2007. Establishment and maintenance of the HPV Register facilitates the
implementation of the National HPV Vaccination Program funded by the
Australian Government. The HPV Register is run by the Victorian Cytology
Service, together with the Department of Health. It plays an essential role
in monitoring and evaluating the HPV Vaccination Program by recording
information about HPV vaccine doses administered in Australia.
Reporting to the HPV Register
HPV vaccination coverage and other reports
For immunisation service providers, the HPV Register has developed overdue
HPV vaccine dose reports for their patients, which are available online via the
secure website. De-identified HPV vaccination coverage data and other reports
have also been developed to inform policy making, and support program
delivery and approved research. National coverage data are made publicly
available via the Immunise Australia website (www.immunise.health.gov.au).
HPV Register statements
The HPV Register sends Completion Statements and History/Reminder

Statements. Immunisation History Statements, containing details of the
vaccinations recorded on the HPV Register, are sent to persons who are overdue
for HPV vaccination within the school-based program. Completion Statements
are sent to persons who have completed the 3-dose HPV vaccination course.
Vaccinated persons and parents/guardians can request a statement at any time
by phoning 1800478734 (1800HPVREG). In the event that booster doses are
required in future, all eligible persons will be notified by the HPV Register.
Details on HPV vaccinations given in the community are provided to the HPV
Register by the immunisation service provider who administers the vaccine.
Vaccination details may be submitted electronically, via data uploads or direct
entry using the secure website, or in hard copy, using one of the approved
notification forms. Immunisation service providers in Queensland and the
Northern Territory report data to the HPV Register via their state/territory
health authority. Immunisation service providers wishing to submit vaccination
data electronically need to be approved and registered with the HPV Register in
order to notify administered doses. General practitioners are required to register
with the HPV Register in order to notify administered doses. Further information
about registration and notification procedures is available from the HPV Register
website (www.hpvregister.org.au) or by phoning 1800478734 (1800HPVREG).
HPV vaccination status
Vaccinated persons and parents/guardians can phone the HPV Register on

1800478734 (1800HPVREG) to obtain their or their childs HPV vaccination
status. Immunisation service providers can also request a persons vaccination
status by phone or can view these online if they are registered with the HPV
Register. The HPV Register initially only recorded vaccinations for females, but
from 2013 will also record vaccinations given to males.
HPV Register secure website
The HPV Register secure website allows registered and approved immunisation
service providers access to the live national HPV Register database to view a
patients vaccination history as well as access to overdue dose reports. Further
information on how to request access to the HPV Register secure website can
be found on the health professionals page of the HPV Register website
(www.hpvregister.org.au) or by phoning 1800478734 (1800HPVREG).
Other immunisation registers

The Australian Q Fever Register (www.qfever.org), established by Meat and
Livestock Australia (MLA), has records of receipt of Q fever vaccination for some
individuals, which can be accessed by registered users (see also 4.15 Q fever).
State/territory government health departments maintain records of
immunisations provided through school-based vaccination programs.
Information on how to access records of vaccines received through school-based
vaccination programs can be obtained from state/territory government health
departments (see Appendix 1 Contact details for Australian, state and territory
Some state/territory governments operate a jurisdictional immunisation register,
though the scope of these varies.
Queensland
The Vaccine Information and Vaccine Administration System (VIVAS) is a

database of vaccination events for all children up to 10 years of age, adolescents
and (some) adults in Queensland who are vaccinated with nationally- or statefunded vaccines.
Immunisation service providers in Queensland are encouraged to report all
vaccinations, either directly to VIVAS via the Queensland Health Vaccination
Record form or using practice software to electronically transfer data (via the
ACIR) to Queensland Health. Vaccination Record forms can be posted reply
paid to VIVAS or faxed directly. Providers reporting to VIVAS should do so at
least once a week to ensure the supply of data is not delayed and is available
for the purposes of calculating parental and provider incentive payments using
ACIR data.
Immunisation service providers enrolled on VIVAS have access to a range

of services, such as reminder notices for overdue or unimmunised patients,
individual vaccination records via local public health units, and Queenslands
centralised Vaccine Distribution System (www.health.qld.gov.au/immunisation/
health_professionals/vivas.asp).
The Northern Territory
The NT Immunisation Register routinely provides relevant data on vaccination

encounters to the ACIR and the HPV Register.
The NT Immunisation Register provides a number of services, such as recall lists
for childhood immunisations in remote areas, individual vaccination records,
and web-based access for NT immunisation service providers for immunisation
histories for children <15 years of age (www.health.nt.gov.au/Centre_for_
Disease_Control/Immunisation/NT_Immunisation_Database/index.aspx).
References
The NT Immunisation Register records details of all vaccines administered

to anyone in the Northern Territory (NT). Immunisation service providers
in the NT are encouraged to report all administered vaccines to the NT
Immunisation Register. This can be done by direct electronic transfer from
some services or via printed lists from clinical software programs and/or
by completing the NT childhood or adult vaccination recording form
(www.health.nt.gov.au/Centre_for_Disease_Control/Immunisation/
Recording_and_Reporting_Forms/index.aspx).
PART 3 VACCINATION FOR SPECIAL RISK GROUPS

3.1 VACCINATION FOR ABORIGINAL AND
TORRES STRAIT ISLANDER PEOPLE
After European colonisation, Aboriginal and Torres Strait Islander (Indigenous)
peoples experienced successive epidemics of infectious diseases with very
high morbidity and mortality; many of these diseases have now become
vaccine preventable. The diseases with the most serious impact were smallpox,
tuberculosis, influenza, measles and syphilis, with estimated mortality rates of
over 30% for smallpox epidemics and 20% for measles epidemics.1 These high
rates of disease were mainly due to a lack of previous exposure,2 followed by
high-density living in newly established settlements. Over many decades, higher
rates of infectious disease have been associated with lower standards of living
and poorer access to water, housing and health care.3 Social determinants of
health, such as low educational outcomes, lack of control over life circumstances
and lack of cultural safety, are also associated with poor health outcomes,
including increased infectious disease risk.4
In recent decades, vaccination has been very successful in eliminating or
substantially reducing the rates of many vaccine-preventable diseases (VPDs),
such as diphtheria, polio, tetanus, hepatitis B, measles, mumps and rubella, in
all Australians, and has made a substantial contribution to improvements in
Indigenous child mortality.5 For some VPDs, control is suboptimal in the general
population despite high vaccination coverage (e.g. pertussis). For others, such
as invasive pneumococcal disease (IPD), greater burdens of illness still occur in
Indigenous persons than in non-Indigenous persons, largely due to the greater
prevalence in Indigenous persons of serotypes for which vaccines do not protect,
and high exposure levels associated with the environmental issues mentioned
above.5 Timeliness of immunisation can also be a factor.5
In recognition of the higher rates of disease in the Indigenous population, some
vaccines are specifically recommended for use in Indigenous persons, or for
administration to a broader age range than is recommended for non-Indigenous
persons (see Table 3.1.1). This chapter discusses the vaccines for which there are
currently different recommendations for Indigenous persons in at least some
parts of Australia, or for which there have been recent changes in this respect.
For children, these are bacille Calmette-Gurin (BCG), Haemophilus influenzae
type b, hepatitis A, influenza and pneumococcal vaccines. For adults, these are
hepatitis B, influenza and pneumococcal polysaccharide vaccines.
All persons aged 50 years
Persons aged 1549 years with underlying conditions increasing the risk of IPD
Booster dose in 2nd year of life in addition to primary course
Children resident in the Northern Territory, Queensland, South Australia and Western
Australia
Annual vaccination
See 4.13 Pneumococcal disease for recommendations on revaccination.
Exact ages may differ between jurisdictions.
Northern Territory, Queensland, northern South Australia
* In addition to those vaccines recommended for all Australians or those in particular medical, occupational, behavioural or other risk groups.
Pneumococcal polysaccharide (23vPPV)
Pneumococcal conjugate (13vPCV)
All persons aged 15 years
Influenza
Consider in all children aged 6 months, especially those aged <5 years
Adults who have not previously been vaccinated against hepatitis B and are non-immune
2 doses in the 2nd year of life
Children resident in the Northern Territory, Queensland, South Australia and Western
Australia
Hepatitis B
Hepatitis A
Neonates living in areas of high TB incidence
BCG
1 dose
Recommendation for Indigenous persons
Vaccine
Table 3.1.1: Additional* vaccines recommended for Indigenous persons, due to their higher risk of disease
3.1 VACCINATION FOR

ABORIGINAL AND TORRES
STRAIT ISLANDER PEOPLE
PART 3 VACCINATION FOR SPECIAL RISK GROUPS 105
3.1.1 Children
BCG vaccine and tuberculosis
BCG vaccine is recommended for Indigenous neonates in regions of high
tuberculosis (TB) incidence, where infants are at higher risk of acquiring this
serious condition. BCG vaccine is provided for Indigenous neonates in the
Northern Territory, Queensland and parts of northern South Australia, but
no longer in Western Australia.6 State/territory health authorities should be
consulted to determine the recommendations for particular areas, including
where BCG vaccination is being considered for neonates <2.5kg in weight. (See
also 4.20 Tuberculosis.)
Tuberculosis was most likely introduced to the Indigenous population in the
early years of European settlement. It became the largest single cause of death for
Indigenous persons in the last quarter of the 19th century and the first quarter
of the 20th century, coinciding with large-scale movement from nomadic life to
settlements.1 In some communities tuberculosis was responsible for more than
20% of deaths.1 Control measures in the second half of the 20th century were
effective for both Indigenous and non-Indigenous populations, but disparities
have persisted. In southern states the notification rate for tuberculosis in
Indigenous persons is comparable to that of Australian-born non-Indigenous
persons,7 but there is considerable geographic variation. The Northern Territory
has consistently had the highest rates of any jurisdiction, and, in 2007, TB
incidence was 13-fold higher among Indigenous persons than non-Indigenous
persons.7 Very high rates among Indigenous persons have been documented
in Far North Queensland8 and northern South Australia,9 but not in New
South Wales in recent years.10 BCG vaccine reduces pulmonary tuberculosis
and provides substantial protection against disseminated forms of the disease
in young children.11 Nevertheless, as the incidence of pulmonary tuberculosis
in adults and the risk of disseminated tuberculosis in infants decreases, the
risk of severe complications of BCG vaccination, documented in indigenous
persons of other countries, becomes a significant consideration.12 BCG vaccine
is usually administered to eligible infants by hospital staff (i.e. midwives or
nurses who have been specially trained) soon after delivery. Injection technique
is particularly important for BCG vaccination, which must be administered
intradermally. Adverse events, such as regional lymphadenitis, are less common
when vaccination is performed by trained staff.13

Since October 2009, only one type of Haemophilus influenzae type b (Hib) vaccine
(PRP-T) has been used in Australian infants (see 4.3 Haemophilus influenzae type b).
Before the introduction of an effective Hib vaccine, not only was the incidence
of invasive Hib disease very high in Indigenous children, particularly in more
remote areas, it also occurred at a younger age than in non-Indigenous children.
Thus, a vaccine to prevent Hib disease in Indigenous children needed to be

immunogenic as early as possible in infancy. The previously used Hib-containing
vaccines, known by the abbreviation PRP-OMP, were more immunogenic at
2 months of age than the other conjugate Hib (PRP-T) vaccines, and so were the
preferred Hib vaccine type for Indigenous children in the first Hib vaccination
programs beginning in 1993. Since then, there has been a dramatic decline in
Hib disease in Indigenous children.14,15 New combination vaccines that include
a Hib (PRP-T) component, and have the advantage of reducing the number of
injections, were introduced in some jurisdictions from November 2005. Initially
PRP-T vaccines were not recommended for Indigenous children in jurisdictions
with higher disease incidence, but either PRP-OMP or PRP-T vaccine could
be given to other children. Following an international shortage of PRP-OMP
vaccine, it was progressively replaced by PRP-T-containing vaccines for all
children. Invasive Hib disease and nasopharyngeal colonisation with Hib are
being closely monitored in high-incidence settings such as the Northern Territory
and Western Australia following this change. To date, there has not been any
change in Hib epidemiology found in association with the change to PRP-Tcontaining vaccines for Indigenous children.
Hepatitis A
Hepatitis A infection was common during the 1990s in Indigenous children

across northern and central Australia.16-18 Most children acquired the virus in the
first 5 years of life, which is a typical finding in populations with disadvantaged
living conditions. Although the symptoms of infection in early childhood
are usually mild or absent, cases complicated by liver failure and death have
been reported among Indigenous children in Far North Queensland18 and the
Kimberley,16 and recorded hospitalisation rates are more than 50 times higher in
Indigenous children than in non-Indigenous children.5 A vaccination program for
Indigenous children was introduced in north Queensland in 1999 and resulted
in a 92% decrease in the number of reported cases, from 787 cases in all children
during the period 19961999 to 66 cases in the period 20002003. This decrease
in hepatitis A disease was observed in both Indigenous and non-Indigenous
children, suggesting a substantial herd immunity effect.19 From 2005, the
hepatitis A vaccination program was extended to include all Indigenous children
aged 2 years resident in the Northern Territory, Queensland, South Australia
and Western Australia. Notifications have fallen by over 90%, from more than
50 per 100 000 in 2005 to less than 5 per 100 000 in 2009.
3.1 VACCINATION FOR

Hepatitis A vaccination is recommended for Indigenous children in those

jurisdictions with high disease incidence: the Northern Territory, Queensland,
South Australia and Western Australia (see 4.4 Hepatitis A). Two doses should
be given, commencing in the 2nd year of life. The recommended ages of
administration vary between states and territories, so jurisdictional health
authorities should be contacted for further details about local vaccination
schedules.
Hepatitis B
See Hepatitis B under Adults below.
Influenza
Annual influenza vaccination is recommended for any person 6 months of age
(see 4.7 Influenza) for whom it is desired to reduce the likelihood of becoming
ill with influenza. Young infants and children aged <5 years, particularly
Indigenous children, are at increased risk for hospitalisation and increased
morbidity and mortality following influenza.5 Annual influenza vaccine is
particularly recommended for Indigenous persons 15 years of age due to the
substantially increased risk of hospitalisation and death from influenza and
pneumonia in this age group (see Influenza in 3.1.2 Adults below).20
The 13-valent pneumococcal conjugate vaccine (13vPCV) is recommended
for all children in a 3-dose infant vaccination schedule, replacing the 7-valent
pneumococcal conjugate vaccine (7vPCV) in all jurisdictions except the Northern
Territory, where it replaced the 4-dose schedule of the 10-valent pneumococcal
conjugate vaccine (10vPCV).
In addition to a primary course of 3 doses of 13vPCV, at 2, 4 and 6 months of
age, a booster dose of 13vPCV is also recommended at 1218 months of age
for Indigenous children in areas of high incidence (i.e. the Northern Territory,
Queensland, South Australia and Western Australia). This 13vPCV booster
dose replaces the 23-valent pneumococcal polysaccharide booster or 4th dose of
10vPCV (which was used at this schedule point for a short time in the Northern
Territory) (see 4.13 Pneumococcal disease).
Prior to the availability of conjugate pneumococcal vaccines, Central Australian
Indigenous children had rates of IPD that were among the highest ever reported
in the world.21 Very high rates were also reported in Indigenous children in
other parts of northern Australia.22,23 High rates of pneumococcal pneumonia
have also been documented in Central Australian Indigenous children,24 and
Streptococcus pneumoniae has been implicated in the high rates of otitis media in
Indigenous children.25 7vPCV was made available for Indigenous children, and
non-Indigenous children with medical risk factors, from 2001, 4 years prior to the
universal program for all children in Australia. The initial program was highly
successful, resulting in a rapid decline in invasive pneumococcal disease due to
the serotypes contained in the 7vPCV among Indigenous and non-Indigenous
children.26-28 However, a wider range of serotypes is responsible for disease
in Indigenous children, and therefore a smaller proportion of cases is vaccine
preventable.22,23 While an initial reduction in IPD was observed, IPD incidence
still remains higher in Indigenous children than in non-Indigenous children.
3.1.2 Adults
Hepatitis B
Indigenous persons should have their risks and vaccination status for
hepatitis B reviewed, be offered testing for previous hepatitis B infection, and
be offered vaccination if non-immune. (See also 4.5 Hepatitis B.)
High rates of mortality and morbidity from hepatitis B among Indigenous
persons have been recognised ever since the original identification of the
Australia antigen in 1965.29 Prior to vaccination, estimates of the prevalence
of markers of previous infection in Indigenous communities ranged from 20
to 100%. In the Northern Territory, the incidence of primary hepatocellular
carcinoma was 10 times greater in Indigenous persons than in non-Indigenous
persons, and comparable to high-incidence countries such as China.30 Vaccination
programs have had substantial impacts on infection and carriage rates in both
Indigenous and non-Indigenous Australians.5,31 However, there is evidence that
new infections continue to occur at a higher rate in Indigenous persons,5,32-34
probably due to a combination of pre-existing high carriage rates, susceptible
persons in older age groups (who were not eligible for vaccination programs),33,34
low coverage in early targeted programs,33,34 and a poorer immunological
response to vaccination.35
Influenza
Influenza and its complications, especially secondary pneumonia, have

historically been major causes of morbidity and mortality in Indigenous persons,
both during and outside pandemic periods. This is probably related to a high
prevalence of medical risk factors such as diabetes, renal disease and excessive
alcohol use, as well as poorer environmental living conditions that facilitate
disease transmission.3 Past pandemics have had disproportionately severe
impacts on Indigenous persons,1 as did the influenza A(H1N1)pdm09 pandemic
in 2009. Reported rates of infection, hospitalisation and death due to pandemic
A(H1N1)pdm09 were 6.6, 6.2 and 5.2 times higher, respectively, in Indigenous
persons than in non-Indigenous persons.36
In recent times, respiratory disease has been responsible for around 8% of deaths
in Indigenous persons, the vast majority being in adults.3 Influenza disease
incidence is greatest in young children and the elderly. Hospitalisation rates
due to influenza and pneumonia are highest in young children and lowest in
older children. Hospitalisation and death rates increase with age in all adults,
but increase much earlier in Indigenous adults than in non-Indigenous adults.
The vast majority of these hospitalisations and deaths are due to pneumonia,
but it is not clear what proportion of these are associated with influenza.5
Younger Indigenous adults (aged 2549 years) have influenza and pneumonia
3.1 VACCINATION FOR

Annual influenza vaccination is recommended for all Indigenous persons aged

15 years (see 4.7 Influenza).
disease rates similar to older non-Indigenous adults (aged 50 years), but have
much higher rates than non-Indigenous persons of the same age. In younger
Indigenous adults rates are at least 8 times higher for hospitalisations and
20 times higher for deaths, compared to younger non-Indigenous adults.5 In
addition, hospitalisation rates in Indigenous children aged <5 years are more
than twice the rates in non-Indigenous children of the same age, and a similar
disparity exists for hospitalisation and death rates in Indigenous adults aged
50 years compared with non-Indigenous adults of the same age.5 Some have
suggested that previous estimates of substantial reductions in hospitalisation and
mortality due to respiratory and cardiovascular disease that were attributed to
influenza vaccination have over-estimated this impact.37 However, the balance
of evidence suggests influenza vaccines are effective in preventing influenzaassociated disease, hospitalisation and death in healthy adults, the elderly and
the medically at risk, including Indigenous persons, although this varies with the
antigenic similarity between vaccine and circulating strains.38
Pneumococcal polysaccharide vaccine is recommended for all Indigenous adults
aged 50 years, and those aged 1549 years who have conditions associated
with an increased risk of IPD. The broader age-based recommendation for
Indigenous adults is due to the high rates of pneumococcal disease and higher
prevalence of risk factors (certain medical conditions and tobacco smoking)
in Indigenous adults, compared to non-Indigenous adults.39 Revaccination is
recommended 5 years after the 1st dose for those first vaccinated at 50 years
of age, and a further revaccination is recommended in some circumstances (see
4.13 Pneumococcal disease). In the Northern Territory, 23-valent pneumococcal
polysaccharide vaccine (23vPPV) is provided for all Indigenous persons aged
15 years. This can be counted as a 1st adult dose of 23vPPV (see 4.13 Pneumococcal
disease). Jurisdictional health authorities should also be contacted to confirm local
practices as they may vary, especially regarding revaccination.
Before the widespread use of pneumococcal conjugate vaccine in infants,
IPD rates in Indigenous adults were up to 20 times higher than in nonIndigenous adults.20 Studies in Far North Queensland and the Kimberley
have demonstrated a favourable impact of 23vPPV on rates of invasive
pneumococcal disease in Indigenous adults.40,41 In some other regions there
has been no decrease in disease, perhaps due to low vaccination coverage
and/or non-vaccine serotype replacement.26,42 At a national level, disparities
remain in disease rates between Indigenous and non-Indigenous adults. As is
the case for influenza and pneumonia, rates of invasive pneumococcal disease
are highest in older Indigenous adults, with rates around 4 times higher in
Indigenous than non-Indigenous adults aged 50 years.5 Rates in younger
adults are slightly lower, but the relative difference between Indigenous and
non-Indigenous persons is much greater, around 12 times higher in Indigenous
than in non-Indigenous adults aged 2549 years.5 Vaccination coverage has
been low in younger Indigenous adults, an issue that requires attention if the
full benefits of vaccination are to be realised.5
Other diseases
The first ever outbreak of Japanese encephalitis (JE) in Australia occurred in the
remote outer islands of the Torres Strait in 1995, with 3 cases, 2 of them fatal.
There have been 5 cases to date acquired in Australia. Since then, JE virus has
been detected frequently in sentinel animal surveillance in the outer islands.
However, the sentinel pig surveillance system has been gradually disbanded
since 2006, with surveillance of the last remaining herd on Cape York ceasing
from the 20112012 wet season.
A JE vaccine (JE-Vax) was first offered to the residents of the Torres Strait Islands
in late 1995 and the vaccine was integrated into the vaccination schedule for
children resident in the Torres Strait Islands, commencing at 12 months of age.43,44
There has not been a case of JE in the Torres Strait since 1998 and the risk of
JE has diminished considerably in the outer islands since the mid-1990s. Most
communities have relocated pigs well away from homes, and major drainage
works on most islands have markedly reduced potential breeding sites for
vector mosquitoes.
Rubella
Although evidence suggests that endemic rubella is well controlled in Australia,

Indigenous women living in rural and remote regions are more likely to be nonimmune to rubella than non-Indigenous non-overseas-born Australians.45 Every
effort should be made to identify non-pregnant seronegative Indigenous women
of child-bearing age and provide measles-mumps-rubella (MMR) vaccine, in
order to prevent congenital rubella syndrome (see 4.18 Rubella). Vaccination with
MMR vaccine also ensures adequate protection against measles (see 4.9 Measles).
3.1 VACCINATION FOR

In 2007, the supply of JE-Vax vaccine into Australia ceased as the manufacturer
stopped production. Because of this shortage of vaccine, for a short period from
September 2007 JE-Vax was restricted to use on the six outer Torres Strait Islands:
Badu, Boigu, Dauan, Mabuiag, Moa and Sabai. Two new JE vaccines, Imojev
and JEspect, are now available for use in those at risk in the Torres Strait
(see 4.8 Japanese encephalitis).
3.1.3 Service delivery

General practitioners, Aboriginal Community Controlled Health Services,
Community Health Services, the Royal Flying Doctor Service and state/territory
corrective services all provide vaccination services to Indigenous persons and
are important to the success of programs to vaccinate Indigenous persons. While
vaccination coverage estimates vary over time and between communities, a
relatively consistent finding has been higher coverage in Indigenous persons in
remote areas than in urban areas.46,47 More recently, however, this has not been
the case for Indigenous children, where coverage has been high in both remote
and urban areas;48 coverage in remote areas is lower for adults than for children.5
For vaccines recommended for both Indigenous and non-Indigenous persons,
coverage is as high, or higher, in Indigenous persons as in non-Indigenous
persons,5 but vaccination is more frequently delayed.49-52 For example, one study
reported that at 7 months of age only 45.2% of Indigenous infants in the Northern
Territory had completed the recommended schedule for that age point (DTPahepB-IPV-Hib/PCV/rotavirus), but by 18 months of age this figure had risen
to 81.2%.51 Coverage for vaccines recommended only for Indigenous persons is
generally lower than for vaccines that are funded for all persons in a particular
age group.53
These disparities point to the importance of identification of Indigenous status,
particularly in mainstream health services, and particularly in urban areas. The
use of patient information systems to record Indigenous status and schedule
preventive health services has the potential to increase opportunistic vaccination
and enable the provision of patient reminders, with resultant improvements
in coverage and timeliness.54 Culturally appropriate service delivery and
communication strategies, as well as use of Indigenous-specific Medicare
items, will also assist in improving access to health services for Indigenous
Australians.55-57
References
3.2 VACCINATION FOR INTERNATIONAL TRAVEL

3.2.1 Introduction
The number of Australians who travel overseas has increased over recent years.
Data available through the Australian Bureau of Statistics suggest that there were
about 6.7 million short-term departures in 2010, with more than half travelling to
destinations other than New Zealand or countries in North America and Europe.1
There are various risks to health associated with international travel, including
exposures to infective agents, extremes of altitude and temperature, and other
physical, psychological and environmental hazards. There could also be poor
quality or limited access to clean water, shelter, hygiene and sanitation facilities,
and health and medical care. The level of health risks will vary with individual
factors, including the travellers underlying health and physiological state, the
itinerary and activities undertaken, and the duration of exposure to various
hazards during travel.
3.2.2 Infections acquired by travellers

Exposure to infectious diseases, some of which are vaccine preventable, is one of
the many health hazards of international travel. Although some of these diseases
are present in Australia, the risk of acquiring them overseas may be higher
because of higher disease incidence in other countries and/or increased risk of
exposure resulting from activities undertaken during the travel period.
Common infections acquired by travellers include those that follow ingestion
of contaminated food or beverages.4,5 Most of these are diarrhoeal diseases due
to enteric pathogens, but infections with extra-intestinal manifestations, such as
hepatitis A and typhoid, are also acquired this way. Vaccines against hepatitis A,
typhoid and cholera are available.
Insect-borne (particularly mosquito-borne) infections, such as malaria and
dengue, are important causes of fever in Australian travellers returning from
endemic areas, particularly Southeast Asia and Oceania.5 Japanese encephalitis
occurs throughout a large part of Asia and the Western Pacific region, including
3.2 VACCINATION FOR

INTERNATIONAL TRAVEL
Travellers with increased risks to their health include young children and
infants; pregnant women; people with underlying medical conditions, especially
immunocompromising conditions due to disease or medical treatment; travellers
spending extended periods in multiple regions with poor resources or in remote
regions; those participating in mass gatherings (major sporting, cultural, social
or religious events involving large numbers of people); and migrant families
travelling back to their country/region of origin to visit friends and relatives
(VFR). Those undertaking VFR travel are more likely to have closer contact
with local populations, stay in remote or rural areas, and consume higher-risk
food and beverages. They are also less likely to adequately perceive health
risks associated with travelling, specifically seek pre-travel health advice, or be
adequately vaccinated or prophylaxed.2,3
Papua New Guinea. Yellow fever occurs only in parts of Africa and Central and
South America, while tick-borne encephalitis occurs in parts of Europe and Asia.
Vaccines are available for protection against Japanese encephalitis, yellow fever
and tick-borne encephalitis.
Vaccine-preventable infections transmitted via aerosols and/or droplets include
influenza, meningococcal disease, measles, mumps and varicella (chickenpox);
influenza is typically the most frequent vaccine-preventable infection among
travellers.6 Incidences of measles and mumps are higher in many overseas
countries, including some developed countries, than in Australia. Tuberculosis is
a rare infection in travellers, and is more likely to be acquired by expatriates who
live in endemic areas for long periods than by short-term visitors.
Blood-borne and sexually transmitted infections, such as hepatitis B, hepatitis C
and human immunodeficiency virus (HIV), may pose a threat to some Australian
travellers. In some areas, there is the possibility that these viruses and other
blood-borne agents may be transmitted by healthcare workers using non-sterile
medical equipment or other poor infection control practices. Hepatitis B vaccine
is relevant to many travellers.
Travellers may be exposed to a variety of other exotic infectious agents, such
as rabies (from bites or scratches from rabid dogs and other mammals in many
countries), schistosomiasis (from exposure to water infested with the parasites, in
Africa in particular), and leptospirosis (through activities like rafting or wading
in contaminated streams). Of these, only rabies can be prevented by vaccination.
Some other vector-borne diseases and parasitic (including protozoal and
helminthic) diseases are also important for international travellers, some
of which are preventable through appropriate barrier precautions and
chemoprophylaxis (e.g. malaria).
3.2.3 Practical aspects of recommending vaccinations for travellers

Although important, recommending appropriate vaccinations is not the only
component of a pre-travel medical consultation, and vaccines relevant for
travelling are not restricted to those for prevention of diseases that occur most
commonly overseas (travel vaccines). Recommendation of a vaccine for
travelling only on the basis of the destination country is undesirable. There is no
single correct list of vaccines for travelling to any single country.
In a pre-travel medical consultation, it is prudent to also acquire adequate
information regarding:
relevant personal information of the traveller, including age, pregnancy
or planning of pregnancy, or even possible financial constraints
underlying medical conditions of the traveller, particularly
immunocompromising conditions, and current medications
vaccination history (including adverse events following immunisation) and

allergy history of the traveller
detailed intended itinerary, including date of departure (and time period
available for vaccinations), specific localities and routes, rural versus urban
stay, duration of stay, likely access to healthcare and other services, and
probability of deviation from planned itinerary
purpose(s) of travel and intended activities, especially those susceptible to
various environmental risks and hazards
plans for travel insurance.
This information will not only facilitate recommendations of preventive
vaccinations and/or chemoprophylaxis that are commensurate with exposure
risks and tailored to the proposed trip, but also provision of other important
preventive health advice (e.g. food and water precautions, avoidance of bites
from mosquitoes or other arthropods) and advice regarding management of
possible health conditions during travel.
Some overseas organisations, such as schools, colleges and universities, have
policies requiring evidence of vaccination and/or immunity against some
vaccine-preventable diseases, for example, measles and meningococcal disease.
These requirements should be taken into account while planning and scheduling
immunisation prior to departure.
Routinely recommended vaccines (not specifically related to travelling overseas)

All travellers should be up to date with current standard vaccination
recommendations. Consideration should also be given to any other vaccines
that may be relevant to the individuals health status or underlying medical
conditions, occupation or lifestyle (e.g. pneumococcal polysaccharide vaccine for
an elderly person or person otherwise recommended to have had pneumococcal
vaccine, hepatitis B vaccine for a first aid officer). The probability of exposure
to some of these diseases may be greater while travelling overseas, even to
developed countries (e.g. measles and mumps). For some itineraries, it may be
appropriate for some booster doses to be received sooner (i.e. before travel) than
at the routine recommended time (e.g. diphtheria-tetanus booster).
Selected vaccines based on travel itinerary, activities and likely risk of
disease exposure
A risk assessment approach should be adopted in recommending some selective
vaccines based on travel itineraries (travel vaccines). Potential risks of disease
exposure and protective benefits from vaccinations should be weighed against
potential adverse effects and both non-financial and financial costs arising from
vaccinations. Priority should be given to vaccines for diseases that are common
3.2 VACCINATION FOR

The vaccination needs for a traveller may be conveniently considered in

several categories.
and of significant impact (e.g. influenza and hepatitis A), and to those diseases
that, although less common, have severe potential adverse outcomes (e.g.
Japanese encephalitis and rabies). Booster doses should be considered where
appropriate (see Table 3.2.1). Because of the imminence of departure, sometimes
an accelerated schedule may be considered appropriate (e.g. for hepatitis B or
the combined hepatitis A/hepatitis B vaccine see the relevant disease-specific
chapters in Part 4). Note that, while immunity may be established sooner with
the accelerated schedule, an additional dose is required about a year later for
completion of the course to augment long-term protection. For children, the
lower age limits for recommendation of selected vaccines should be noted (see
Table 3.2.2).
Vaccines required by International Health Regulations or for entry into
specific countries
Currently, yellow fever vaccination is the only vaccination that may be required
by the International Health Regulations for travelling in certain situations, for
the purpose of individual protection if one is likely to be exposed and/or for
protection of vulnerable populations (in countries with relevant vectors) from
importation of the disease. Some countries, including Australia, may require
documented evidence of yellow fever vaccination as a condition of entry or exit.
Although there are exceptions, this would mostly be relevant for travellers who
originate from, or have travelled or made transit through, countries in Africa or
South America (see 4.23 Yellow fever and 3.2.6 Further information below). Current
requirements should be referred to when advising travellers regarding yellow fever
immunisation requirements.
The Ministry of Health of Saudi Arabia annually issues specific requirements
and recommendations for entry visas for travellers on pilgrimage to Mecca in
Saudi Arabia (Hajj and Umra). For pilgrims travelling directly from Australia,
only evidence of quadrivalent meningococcal vaccination is currently mandatory.
However, current requirements should be referred to when advising prospective
Hajj and Umra pilgrims (see 3.2.6 Further information below).
Vaccine administration and documentation

It is not unusual that multiple vaccines would be required before travelling.
The standard recommendations and precautions for administration of multiple
vaccines are applicable (see 2.2 Administration of vaccines).
Multiple clinic visits may be necessary when multiple vaccines and vaccines
that involve multiple doses are involved (e.g. rabies pre-exposure prophylaxis
or hepatitis B vaccine). Special attention should be paid to the appropriate
scheduling of these visits, taking into account dose interval precautions (e.g.
multiple live vaccines), requirement for pre-vaccination tests (e.g. tuberculin
skin test), and potential interference by some antimalarials if relevant (e.g. rabies
vaccine). Ideally, vaccination courses should be started early enough before
departure to allow for the period when most adverse events are expected to
occur and to allow sufficient time for adequate immunity to develop.
It is important to document travel vaccines appropriately, not only in the
clinics record but also in a suitable record that can be carried by the traveller.
It is recommended that the record also includes all the other routinely
recommended vaccines that the traveller has ever received. An International
Certificate of Vaccination or Prophylaxis (ICVP), issued by an authorised medical
practitioner in accordance with the International Health Regulations (2005), is
required for yellow fever vaccination.
3.2.4 Vaccines
Detailed information regarding each of the vaccines discussed below is provided
in each of the corresponding disease-specific chapters of this Handbook. This
section provides some general guidance in considering whether a particular
vaccine may be advisable for a traveller.

Diphtheria, tetanus and pertussis
Adult travellers should be adequately protected against tetanus before departure,

particularly if their risk of sustaining tetanus-prone wounds is high or there
could be delays in accessing health services where they can receive tetanus
toxoid boosters safely if required. Protection against pertussis should also be
offered at this opportunity (as dTpa) if no previous dose of dTpa has been given
(see 4.12 Pertussis). Before departure, adults should be given a booster dose of
dT, if more than 10 years have elapsed since the last dose, or dTpa if not given
previously. For high-risk trips, consider giving a booster of either dTpa or dT if
more than 5 years have elapsed (see 4.19 Tetanus).
Hepatitis B
Most Australian children born since 2000, and a high proportion of adolescents,
will have been vaccinated against hepatitis B under the NIP or jurisdictional
school-based vaccination programs. Long-term or frequent travellers to regions
3.2 VACCINATION FOR

All prospective travellers should have been vaccinated according to the

recommended vaccination schedule appropriate for the travellers age and
underlying health conditions. All children should be vaccinated according
to the NIP schedule. In exceptional circumstances, the NIP vaccines may be
administered at the minimum age rather than the recommended age (see 2.1.5
Catch-up, Table 2.1.5 Minimum acceptable age for the 1st dose of scheduled vaccines
in infants in special circumstances). Children vaccinated using the minimum age
rather than the recommended age may require extra vaccine doses to ensure
adequate protection. The minimum interval requirements between doses must
be observed (see 2.1.5 Catch-up, Table 2.1.7 Minimum acceptable dose intervals for
children <10 years of age).
of intermediate or high endemicity of hepatitis B, including Central and South

America, Africa, Asia or Oceania, are recommended to be vaccinated against
hepatitis B, due to the potential for inadvertent exposure to hepatitis B virus
through blood-borne or sexual routes, including unplanned medical or dental
procedures. A survey has shown that about half of Australian travellers who
spent at least 3 nights in Southeast or East Asia had participated in at least one
activity with a risk of acquiring hepatitis B.7 (See also 4.5 Hepatitis B.)
Influenza and pneumococcal disease
Older travellers (usually those aged 65 years) and those with any relevant
underlying medical or behavioural risk factors (see 4.7 Influenza and 4.13
Pneumococcal disease) should receive the seasonal influenza vaccine and/or
should have received the 23-valent pneumococcal polysaccharide vaccine. All
travellers should consider influenza vaccine, especially if travelling during the
influenza season of the destination region(s). The influenza vaccine is particularly
relevant if influenza epidemics are occurring at the travellers destination(s), and
for travellers in large tourist groups, especially those that include older persons,
or travelling on cruises, where they are likely to be in confined circumstances for
days to weeks (see 4.7 Influenza).
Measles, mumps, rubella and varicella
Most measles outbreaks in Australia now result from an infection imported by

inadequately vaccinated young travellers. Incidences of measles and mumps are
higher in some overseas countries, regions or communities, including developed
countries, than in Australia. Australians born during or since 1966 who have
not received 2 doses of measles-, mumps- and rubella-containing vaccines
should be vaccinated with the MMR vaccine before travelling (noting pregnancy
precautions) (see 4.9 Measles). Varicella vaccine should be offered to unvaccinated
travellers who have not had clinical disease, or where serology demonstrates
lack of immunity in those with an uncertain history of clinical disease (see 4.22
Varicella).
Poliomyelitis
All travellers should be age-appropriately immunised against polio (see 4.14

Poliomyelitis). If travelling to countries where wild poliovirus transmission still
occurs (i.e. Afghanistan, Pakistan, Nigeria and others where polio may have
been re-established or have been imported check recent updates), inactivated
poliomyelitis vaccine (IPV) should be offered to those who have not completed a
3-dose primary course of any polio vaccine, and a single booster dose should be
given to those who have previously completed the primary course. For an up-todate list of affected countries see www.polioeradication.org.
Selected vaccines based on travel itinerary, activities and likely risk of

disease exposure
Cholera
Cholera vaccination is rarely indicated for most travellers,8 as the risk of

acquiring cholera for travellers in general is very low, provided that general
precautions to avoid contaminated food and water are taken. The protective
efficacy against Vibrio cholerae O1 is high (>80%) among children aged 25
years for the initial 46 months after 3 doses, but wanes to become insignificant
afterwards. For those aged >5 years, protective efficacy is about 78% and 63% for
the 1st and 2nd year, respectively, and wanes to become insignificant beyond 2
years after vaccination.9 The vaccine does not protect against the V.cholerae O139
serogroup. It is only indicated for those travellers at considerable risk, such as
those working in humanitarian disaster situations. However, since cholera and
enterotoxigenic Escherichia coli (ETEC) share the same toxin, cholera vaccination
does afford some partial short-term protection against ETEC-caused travellers
diarrhoea. The effect lasts only about 3 months, and the overall reduction of
travellers diarrhoea risk would be less than 15%;10 however, there may be some
travellers who would benefit from improved protection against travellers
diarrhoea, including those with achlorhydria and those at increased risk of severe
or complicated diarrhoeal disease (see 4.1 Cholera).
Hepatitis A
Hepatitis A vaccine should be recommended to all travellers 1 year of age

travelling to moderately or highly endemic countries (including all developing
countries), except those who are likely to have acquired natural immunity
following previous infection (see 4.4 Hepatitis A). There is no longer any place
for the routine use of normal human immunoglobulin to prevent hepatitis A in
travellers (see 4.4 Hepatitis A).
The mosquito-borne Japanese encephalitis virus is endemic in many countries

in Asia and the Western Pacific region, including Papua New Guinea. High risk
of transmission occurs in rural irrigated paddy and pig-farming environments.
Vaccination is recommended for travellers spending a month or more in rural
areas of high risk in endemic regions and should be considered for shorter-term
travellers, particularly if travel is during the wet season or anticipated to be
repeated, and/or there is considerable outdoor activity and/or accommodation
is inadequately screened against mosquitoes. Vaccination is also recommended
for expatriates spending a year or more in Asia, even if much of the stay is in
urban areas (see 4.8 Japanese encephalitis).
3.2 VACCINATION FOR

Certification of cholera vaccination has been abandoned globally, and no

countries have official entry requirements for cholera vaccination.
Meningococcal disease
All children 12 months of age receive meningococcal C conjugate vaccine

(MenCCV) under the NIP.
Up-to-date epidemiological information should be sought to determine the need
for meningococcal vaccination in travellers. The quadrivalent meningococcal
vaccine (which includes serogroups A, C, W135 and Y antigens) is recommended
for those who intend travelling to parts of the world where epidemics of
meningococcal disease occur, in particular the meningitis belt of sub-Saharan
Africa.11 The Saudi Arabian authorities require that all pilgrims travelling to
Mecca (for the Hajj or Umra) have evidence of recent vaccination with the
quadrivalent meningococcal vaccine8 (see 3.2.6 Further information below). The
quadrivalent meningococcal conjugate vaccine (4vMenCV) should be used in
preference to the quadrivalent meningococcal polysaccharide vaccine (4vMenPV)
(see 4.10 Meningococcal disease). There is currently no vaccine available against
serogroup B meningococcal disease.
Rabies
Travellers to rabies-endemic regions should be advised of the risk of rabies

infection, and to avoid close contact with either wild, stray or domestic animals,
in particular dogs, cats, monkeys and bats. Travellers should also be aware of
the importance of appropriate immediate wound care of all animal bites and
scratches (see 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus)).
Recommendation for pre-travel (i.e. pre-exposure prophylaxis) rabies vaccination
(or, where indicated, booster doses) is based on an assessment of the likelihood
of contact and risk of exposure to potentially rabid animals, the access to
appropriate healthcare and availability of post-exposure prophylaxis, including
rabies immunoglobulin, should there be an at-risk exposure, and the timeliness
of such access after exposure. The previous recommendation for pre-exposure
prophylaxis based on duration of stay in rabies-endemic areas (i.e. for more
than a month) is arbitrary, and most Australian travellers who have required
post-exposure prophylaxis have undertaken shorter periods of travel. A lower
threshold for recommending rabies pre-exposure prophylaxis should be adopted
for children travelling to endemic areas (see 4.16 Rabies and other lyssaviruses
(including Australian bat lyssavirus)). Vaccination against rabies before travel
ensures that a safe and efficacious vaccine has been used and simplifies the
management of a subsequent exposure because fewer doses of vaccine are
needed. It also means that rabies immunoglobulin, which is often extremely
expensive, difficult or even impossible to obtain in many developing countries, is
not required, and reduces the urgency of post-exposure prophylaxis.
Tick-borne encephalitis
Tick-borne encephalitis (TBE) is caused by a tick-borne RNA flavivirus and

may involve the central nervous system. The disease is prevalent in parts of
temperate regions of central and northern Europe and across northern Asia.
Travellers are at particular risk when hiking or camping in forested areas in
endemic regions during the summer months. Safe and effective vaccines are
available. Vaccination is recommended only for individuals with a high risk
of exposure. Two inactivated TBE vaccine formulations (from Austria and
Germany) are available in Europe (based on the European subtype), and two
other formulations, based on the Far Eastern subtypes, are available in Russia.
There is limited evidence that suggests the Austrian and German vaccines induce
cross-protecting immunity against the Far Eastern and Siberian subtypes.12 While
the conventional schedule for completing the primary vaccination course takes
9 to 12 months, accelerated schedules are available (see 3.2.6 Further information
below). While no TBE vaccine is registered in Australia, a small stock of vaccine
may be available in Australia for use under the Special Access Scheme.
Tuberculosis
For travellers who would require the BCG vaccine, the following precautions
need to be considered when scheduling their vaccination visits:
The BCG vaccine should preferably be given at least 3 months prior to
entry into endemic areas.
Other live viral vaccines (e.g. MMR, varicella or yellow fever) should
be administered concurrently or with a minimum 4-week interval from
BCG vaccination.
A 2-step tuberculin skin test (Mantoux test), performed by trained and
accredited healthcare practitioners, is recommended prior to receiving the
BCG vaccine for all individuals except infants aged <6 months.
Reactivity to tuberculin may be depressed for as long as 4 weeks following
viral infections or live viral vaccines, particularly measles infection and
measles-containing vaccines.
Tuberculin skin tests and BCG vaccine are available from state/territory
tuberculosis services.
3.2 VACCINATION FOR

Vaccination with BCG vaccine is generally recommended for tuberculinnegative children <5 years of age who will be staying or living in countries
with a high prevalence of tuberculosis for an extended period. There is less
evidence of the benefit of vaccination in older children and adults, although
consideration should be given to vaccination of tuberculin-negative children
5 years but <16 years of age who may be living or travelling for long periods
in high-risk countries (defined as having an incidence >40 per 100 000
population) (see 4.20 Tuberculosis).
Typhoid
Typhoid vaccine may be recommended to travellers 2 years of age travelling

to endemic regions, including the Indian subcontinent, most Southeast Asian
countries and several South Pacific nations, including Papua New Guinea. This
advice is also relevant for those travelling (back) to endemic regions to visit
friends and relatives (VFR travel). Inactivated parenteral or live oral typhoid
vaccine formulations are available (see 4.21 Typhoid).
Yellow fever
The World Health Organization no longer routinely reports on yellow fever

infected areas. The yellow fever vaccine is now recommended for all travellers
aged 9 months to areas where there is evidence of persistent or periodic
yellow fever virus transmission, or when required by the country for entry (see
4.23 Yellow fever).3 Countries requiring yellow fever vaccination for entry have
legislation to do so in accordance with the International Health Regulations.
Country requirements are subject to change at any time. Updates can be found
at www.who.int/ith. To minimise the risk of yellow fever introduction, some
countries, including those without current disease transmission such as Australia,
may require proof of vaccination from travellers who have travelled to countries
with risk of transmission. See also the Australian Government Department of
Healths yellow fever fact sheet (www.health.gov.au/yellowfever).
The risk of being infected with the yellow fever virus, country entry
requirements, and individual factors like age, pregnancy and underlying
medical conditions must be taken into account when considering yellow fever
vaccination. Vaccination is generally not recommended when travelling to areas
where there is low potential for yellow fever virus exposure (i.e. no human
yellow fever cases ever reported and evidence to suggest only low levels of
yellow fever virus transmission in the past). However, vaccination might be
considered for a small subset of travellers to these areas who are at increased
risk of exposure to mosquitoes or unable to avoid mosquito bites.3 For people
aged 60 years, the risk of adverse events associated with the vaccine should be
weighed against the potential for disease exposure and benefit of yellow fever
vaccination, as this age group has an increased risk of severe adverse events after
primary yellow fever vaccination13 (see 4.23 Yellow fever).
Brand name
Dose (adults)
Route
Influenza (seasonal)
Hepatitis B
Diphtheria-tetanuspertussis-inactivated
poliomyelitis (dTpaIPV)
Boostrix
Diphtheria-tetanuspertussis (dTpa)
0.5 mL
1.0 mL
H-B-Vax II
Various
1.0 mL
0.5 mL
0.5 mL
0.5 mL
Engerix-B
Adacel Polio
or
Boostrix-IPV
Adacel
or
ADT Booster
Diphtheria-tetanus
(dT)
0, 1, 6 months
Single dose
IM or
intradermal,
depending on the
formulation
0, 7, 21 days and 12 months*
0, 1, 2, 12 months or
0, 1, 6 months or
A primary course is 3 doses

of dT-containing vaccine,
given a minimum of 4 weeks
apart; followed by booster
doses 10 and 20 years after.
Dosing intervals
IM
IM
IM
IM
IM
Vaccine (adults)
As different strains circulate from

year to year, annual vaccination
with the current formulation is
necessary.
A completed series probably gives

life-long immunity.
For persons undertaking high-risk

travel, consider giving a booster
dose of either dTpa or dT (as
appropriate) if more than 5 years
have elapsed since their last dose of
dT-containing vaccine.
Prior to travel, adults should receive

a booster dose of dT (or dTpa if not
given previously), if more than 10
years have elapsed since their last
dose of dT-containing vaccine.
Duration of immunity and/or

booster recommendations
Table 3.2.1: D
ose and routes of administration of commonly used vaccines in adult travellers (the lower age limit for the
adult dosage varies with individual vaccines please refer to the product information)
3.2 VACCINATION FOR

Brand name
Dose (adults)
Route
Varicella (chickenpox)
Poliomyelitis
Pneumococcal
Measles-mumpsrubella
Varivax
Refrigerated
or
Varilrix
0.5 mL
SC
0, 4 weeks if aged 14 years
If there is a lack of reliable

history of chickenpox or the
person is non-immune, and
has not been vaccinated in
childhood
A 2-dose schedule provides longlasting immunity.
See Diphtheria-tetanus-pertussis-inactivated poliomyelitis (dTpa-IPV) above and 4.14 Poliomyelitis.
A booster dose 10-yearly is

only necessary if travelling to a
poliomyelitis endemic country.
Recommendations vary according

to age, Indigenous status and
predisposing conditions see 4.13
Pneumococcal disease.
A 2-dose schedule provides longlasting immunity.
Combination
vaccines (dTpaIPV)
For unvaccinated adults,

3 doses with minimum
interval of 1 to 2 months
between doses
Single dose, for older

adults, and younger adults
with predisposing medical
conditions see 4.13
Australians born during

or since 1966 who do not
have documented evidence
of having received 2 doses
of measles-, mumps- and
rubella-containing vaccine
should receive at least 1
dose of MMR vaccine before
travel

0.5 mL
SC
IM
SC
SC/IM
Dosing intervals
IPOL
Pneumovax 23
or
0.5 mL
0.5 mL
M-M-R II
Prevenar 13
0.5 mL
Priorix
Vaccine (adults)
Brand name
Dose (adults)
Route
Dosing intervals
Meningococcal
ACW135Y
(quadrivalent
conjugate 4vMenCV)
Menactra
or
0.5 mL
0.5 mL
Imojev
Menveo
0.5 mL
1.0 mL (mixed
vaccine)
JEspect
Note: Only for use

in persons 16
years of age
Vivaxim
Hepatitis A/typhoid
combined
1.0 mL
Vaqta Adult
formulation
1.0 mL
1.0 mL
Havrix 1440
Twinrix (720/20)
0.5 mL
Avaxim
Hepatitis A/B
combined
Hepatitis A
IM
SC
IM
IM
IM
IM
IM
IM
A dose of monovalent hepatitis A

vaccine given 636 months later
probably gives life-long immunity.
The duration of protection against
typhoid is probably 3 years.
The need for, and timing of, a
booster dose has not yet been
determined.
determined.
determined. Where not otherwise
indicated 4vMenCV should be
given in preference to 4vMenPV.
0, 28 days
Single dose
Single dose

life-long immunity to both hepatitis
A and B.

life-long immunity.

Single dose
0, 7, 21 days and 12 months*
0, 1, 6 months or
0, 618 months
0, 612 months
0, 612 months
Selected vaccines based on travel itinerary, activities and likely risk of disease exposure
Vaccine (adults)
3.2 VACCINATION FOR

Brand name
Dose (adults)
Route
Dosing intervals
Stamaril
Typhim Vi
0.5 mL
0.5 mL
Typherix
or
A single oral
capsule per
dose
1.0 mL
Rabipur
Inactivated
Rabies Virus
Vaccine
Vivotif Oral
1.0 mL
0.5 mL
Mrieux
Inactivated
Rabies Vaccine
Menomune
or
Mencevax ACWY
IM/SC
IM
Oral
IM
IM/SC
SC
Single dose
Single dose
One capsule each on days

1, 3, 5 (3-dose course), and
preferably also day 7 (4-dose
course)
0, 7, 2128 days
0, 7, 2128 days
Single dose
A 4th capsule of oral typhoid vaccine on day 7 is preferred (see 4.21 Typhoid).
Vivaxim is registered for use in persons aged 16 years.
* This rapid schedule should be used only if there is very limited time before departure to endemic regions.
Yellow fever
Typhoid
Rabies (pre-exposure
prophylaxis)
Meningococcal
ACW135Y
(quadrivalent
polysaccharide
4vMenPV)
Selected vaccines based on travel itinerary, activities and likely risk of disease exposure
Vaccine (adults)
Give 10-yearly boosters if the

person is at ongoing risk.
Give 3-yearly boosters if the person

is at ongoing risk.
If the person is at ongoing risk,

repeat the course after 3 years if a
3-dose course was given initially;
repeat the course after 5 years if a
4-dose course was given initially.
Boosters are not recommended for

frequent travellers unless they are
at ongoing, high occupational risk
of exposure then either measure
rabies antibody titres (and boost if
titres are reported as inadequate) or
give a single booster dose 2-yearly.
Give 35-yearly boosters if the

person is at ongoing risk.
Where not otherwise indicated,

4vMenCV should be given in
preference to 4vMenPV.

3.2.5 Vaccinating the traveller with special risk factors

See 3.3 Groups with special vaccination requirements and the disease-specific
chapters in Part 4 for recommendations for travellers who are either pregnant or
immunocompromised.
Children should receive relevant travel vaccines, according to age-specific
dosage and schedules as shown in Table 3.2.2; further information relating to
administration is provided in the relevant disease-specific chapters in Part 4.
Particular effort should be made to encourage the families of recent migrants to
Australia to seek health advice before travelling to their country of origin to visit
relatives and friends.14
Table 3.2.2: Recommended lower age limits of travel vaccines for children*
Vaccine
Lower age limit
Dose/route
Dosing intervals
Avaxim
2 years
0.5 mL IM
2 doses: 0 and 612 months
Havrix Junior
2 years
0.5 mL IM
0.5 mL IM
Hepatitis A
Vaqta Paediatric/Adolescent 1 year

formulation
Hepatitis A/B combined
1 year
0.5 mL IM
3 doses: 0, 1 and 6 months
Twinrix (720/20)
1 year
1.0 mL IM
JEspect
1 year (to <3years) 0.25 mL IM
2 doses: 0 and 28 days
3 years
0.5 mL IM
2 doses: 0 and 28 days
1 year
0.5 mL SC
Single dose
Menveo
9 months
0.5 mL IM
Single dose
Menactra
9 months
0.5 mL IM
Single dose
Mencevax ACWY
2 years
0.5 mL SC
Single dose
Menomune
2 years
0.5 mL SC
Single dose
Imojev
Meningococcal ACW135Y
(quadrivalent conjugate
4vMenCV)
Meningococcal ACW135Y
(quadrivalent polysaccharide
4vMenPV)
3.2 VACCINATION FOR

Twinrix Junior (360/10)
Vaccine
Lower age limit
Dose/route
Rabies
Dosing intervals
Pre-exposure:
Mrieux Inactivated Rabies

Vaccine
No lower age limit
1.0 mL IM/
SC
3 doses: 0, 7, 2128 days
Rabipur Inactivated Rabies

Virus Vaccine
No lower age limit
1.0 mL IM
3 doses: 0, 7, 2128 days
Vivotif Oral
6 years
Oral capsule One capsule each on days

1, 3, 5 (3-dose course), and
preferably also day 7 (4-dose
course)
Typherix
2 years
0.5 mL IM
Single dose
Typhim Vi
2 years
0.5 mL IM
Single dose
9 months#
0.5 mL IM/
SC
Single dose
Typhoid
Yellow fever
Stamaril
* See also minimum ages in Table 2.1.5 Minimum acceptable age for the 1st dose of scheduled vaccines in
infants in special circumstances.
This schedule is not recommended if prompt protection against hepatitis B is required
(see 4.5 Hepatitis B).
JEspect is registered for use in persons aged 18 years, but can be administered to persons
aged 12 months in circumstances where an alternative is not available or contraindicated
(see 4.8 Japanese encephalitis).
4vMenCV is preferred over 4vMenPV (see 4.10 Meningococcal disease).
A 4th capsule of oral typhoid vaccine on day 7 is preferred (see 4.21 Typhoid).
# Yellow fever vaccine is contraindicated in infants <9 months of age. (Vaccination may be
considered in outbreak control situations for infants from 6 months of age.) (See 4.23 Yellow fever.)
3.2.6 Further information

International travellers health risks are changing constantly. Up-to-date
information and knowledge of the changing epidemiology and occurrence of
outbreaks of a variety of infectious and emerging diseases is essential. Useful
online information sources include:
the World Health Organization (WHO) for disease outbreak news
(www.who.int), and its Travel and health section (www.who.int/topics/
travel/en) for more specific advice on travel and health, including travel
vaccination recommendations
Travelers health section of the United States Centers for Disease Control and
Prevention (CDC) website (wwwnc.cdc.gov/travel)
Travel health and quarantine section of the Australian Government Department

of Health website (www.health.gov.au/internet/main/publishing.nsf/
Content/health-pubhlth-strateg-quaranti-index.htm)
Smartraveller the Australian Governments travel advisory and consular
information service, which provides up-to-date advice regarding health,
safety and other risks of specific destinations to Australian travellers (www.
smartraveller.gov.au).
Comprehensive technical advice on international travel and health, including
but not limited to vaccinations, is available in the latest editions of the WHO
publication International travel and health (available at www.who.int/ith/en) and
the US Centers for Disease Control and Prevention (CDC) publication Health
information for international travel (the Yellow book) (available at www.cdc.gov/
travel).
The Ministry of Health of Saudi Arabias requirements and recommendations for
travellers on pilgrimage to Mecca (Hajj and Umra) are published annually in the
Weekly Epidemiological Record of the WHO (www.who.int/wer).8
References
3.2 VACCINATION FOR

3.3 GROUPS WITH SPECIAL VACCINATION REQUIREMENTS

This chapter considers the use of vaccines in persons who have special
vaccination requirements, persons who may experience more frequent
adverse events following immunisation and persons who may have a
suboptimal response to vaccination. Recommendations for vaccination of
persons at occupational or lifestyle-associated risk are also included. Although
recommendations are discussed under each sub-heading in this chapter, it is
also important to refer to the relevant disease-specific chapters in Part 4 for
further information.
Administration of certain vaccines is a priority for some persons with
medical conditions that increase the risk of infectious diseases, even in the
absence of specific immune defects, for example, the use of influenza and
pneumococcal vaccines in individuals with an increased risk of complications
from these diseases. The presence of additional recommendations specific to
groups discussed in this section underpins the importance of pre-screening
those attending for immunisation and being certain to regularly review the
vaccination needs of those seeking medical attention for any reason.
3.3.1 Vaccination of persons who have had an adverse event

following immunisation
Adverse reactions after being given a vaccine (also known as vaccine side
effects) do sometimes occur. It is usually not possible to predict which
individuals may have a mild or a rare, serious reaction to a vaccine. However, by
following guidelines regarding when vaccines should and should not be used,
the risk of adverse effects can be minimised. The term adverse event following
immunisation (AEFI) refers to any untoward medical occurrence that follows
immunisation, whether expected or unexpected, and whether triggered by the
vaccine or only coincidentally occurring after receipt of a vaccine dose.1 For more
information on AEFI, see 2.3.2 Adverse events following immunisation.
Serious adverse events occur rarely after immunisation. Recognised rare
and serious AEFI are described in 2.3.2 Adverse events following immunisation.
Pre-vaccination screening should identify persons who have experienced an
AEFI and also identify persons with conditions that are precautions and/or
contraindications to vaccines (see Table 2.1.1 Pre-vaccination screening checklist).
The relevant disease-specific chapter(s) in Part 4 of this Handbook should be
consulted for each vaccine regarding contraindications and precautions that are
relevant. In general, persons who have had a non-serious adverse event can be
safely revaccinated by their usual immunisation service provider. Determining
whether revaccination should be provided after a serious event has occurred
following vaccination can be more challenging. At the individual patient
level, an assessment should be made as to whether the vaccine(s) was causally
related to the adverse event. This includes a thorough medical assessment,
including determining the need for, or availability of, specific tests to predict
whether the AEFI is likely to recur with subsequent doses. Persons who have
experienced a serious adverse event following immunisation (other than a
contraindication, such as anaphylaxis confirmed as triggered by a vaccine or one
of its components) can usually subsequently be vaccinated under close medical
supervision. However, further advice should be sought where appropriate,
by referral to a specialist clinic for the management of persons with special
vaccination requirements (including persons who have had a previous AEFI).
Information about specialist immunisation clinics, or the contact details for
paediatricians or medical specialists with experience in management of persons
with AEFI, are usually available from state and territory health authorities (see
authorities and communicable disease control) and from the Immunise Australia
website (www.immunise.health.gov.au).
Allergies
It is important that immunisation service providers assess each individual

for a history of allergies and previous reactions to vaccines prior to giving
any dose of vaccine. Depending on the allergy identified, there often may
not be a contraindication to vaccination. For example, a history of allergy to
antibiotics most commonly relates to -lactam or related antibiotics and is not a
contraindication to vaccines that contain neomycin, polymyxin B or gentamicin.
Previous reactions to neomycin that only involved the skin are not considered a
risk factor for a severe allergic reaction or anaphylaxis to vaccines manufactured
with neomycin because there are only trace amounts of this antibiotic in the final
product.3 Similarly, the measles and mumps components of measles-mumpsrubella (MMR) vaccine contain only a negligible quantity of egg ovalbumin
and do not contraindicate MMR vaccination of persons with egg allergy (even
anaphylaxis) (see Vaccination of persons with a known egg allergy below).4-7
It is important that persons who experience an allergic reaction associated with a
vaccine dose are fully investigated appropriately to ascertain the possible causal
3.3 GROUPS WITH SPECIAL

VACCINATION REQUIREMENTS
Vaccines rarely produce allergy or anaphylaxis (a rapid and life-threatening

form of allergic reaction). Overall, the risk of anaphylaxis after a single vaccine
dose has been estimated as less than 1 case per 1 million; however, this risk
varies depending on the vaccine type.2 Antibiotics, gelatin and egg proteins
are the components most often implicated in allergic reactions. Yeast has only
rarely been associated with vaccine-related allergic reaction. Persons allergic to
latex may be at risk from some vaccines. This is usually not from the vaccine
formulation itself, but from the presence of latex in the equipment used to
hold the vaccine, such as vaccine vial stoppers (bungs) and syringe plungers.
However, very few vaccine bungs contain natural latex. Before administering
the vaccine, consult the product information (PI) of each vaccine to check for the
presence of latex or, where not listed on the PI, contact the vaccine manufacturer
for specific details.
relationship to vaccination, and determine if, and under what circumstances,

repeat doses of vaccine can be provided. Specialist advice should be sought
where appropriate (see above).
Vaccination of persons with a known egg allergy

Influenza vaccines
A history of anaphylaxis or a severe allergic reaction to eggs has previously been

considered an absolute contraindication to influenza vaccination. However,
there have now been a number of studies indicating that the majority of persons
with egg allergy, including anaphylaxis, can be safely vaccinated with influenza
vaccines that contain less than 1g of ovalbumin per dose8-10(see 4.7 Influenza).
The majority of vaccine-associated anaphylaxis cases reported as likely due to
egg allergy occurred following administration of one of the older formulations
of influenza vaccine.9 Today, due to manufacturing changes, the quantity of
egg ovalbumin present in the majority of influenza vaccines used in Australia
is less than 1g of ovalbumin per dose.8 Note that the amount of residual egg
ovalbumin may vary from year to year due to manufacturing processes, vaccine
batches and country of origin. The PI of the vaccine to be given should be
checked for the vaccines ovalbumin content prior to vaccine administration.8,9,11,12
Given that there is still a small risk of anaphylaxis, it is essential that persons
with a history of a severe allergic reaction to eggs are vaccinated in facilities that
have staff who are able to recognise and treat anaphylaxis.8,9 Allergy testing (e.g.
skin testing) with influenza vaccine prior to administration is not recommended,
as there is poor correlation between test results and vaccine tolerance.8,9 Detailed
information on influenza vaccination of individuals with an allergy to eggs
can be found in the Australasian Society of Clinical Immunology and Allergy
(ASCIA) guidelines8 (available at www.allergy.org.au/health-professionals/
papers/influenza-vaccination-of-the-egg-allergic-individual).
Other vaccines
Vaccines used in Australia that contain traces of egg ovalbumin, in addition to

most influenza vaccines, are:
rabies vaccine, Rabipur (see 4.16 Rabies and other lyssaviruses (including
Australian bat lyssavirus))
yellow fever vaccine, Stamaril (see 4.23 Yellow fever)
Q fever vaccine, Q-Vax (see 4.15 Q fever).
Of these vaccines, yellow fever and Q fever vaccines contain a higher amount of
ovalbumin than is present in the currently available influenza vaccines and are
contraindicated in persons with known severe allergy to eggs. Persons with egg
allergy requiring vaccination with either yellow fever or Q fever vaccines should
seek specialist immunisation advice from state or territory health authorities
(see Appendix 1 Contact details for Australian, state and territory government health
authorities and communicable disease control).
For rabies vaccination, pre- or post-exposure vaccination should be undertaken
using the human diploid cell vaccine (HDCV; Mrieux Inactivated Rabies
Vaccine), and not using the purified chick embryo cell vaccine (PCECV; Rabipur
Inactivated Rabies Virus Vaccine) (see 4.16 Rabies and other lyssaviruses (including
Australian bat lyssavirus)).
Although measles and mumps (but not rubella or varicella) vaccine viruses are
grown in chick embryo tissue cultures, it is now recognised that measles- and
mumps-containing vaccines contain negligible amounts of egg ovalbumin
and can be safely administered to persons with a known egg allergy (see 4.9
Measles).4-7
3.3.2 Vaccination of women who are planning pregnancy,

pregnant or breastfeeding, and preterm infants
Women planning pregnancy
Refer to the relevant disease-specific chapters in Part 4 for more information

about vaccination requirements for these diseases.
It is also important that women of child-bearing age who present for
immunisation should be questioned regarding the possibility of pregnancy as
part of the routine pre-vaccination screening, to avoid inadvertent administration
of a vaccine(s) not recommended in pregnancy (see 2.1.4 Pre-vaccination
screening).
Pregnant women
Table 3.3.1 summarises the recommendations for vaccine use in pregnancy. More
detailed information is also provided under the Pregnancy and breastfeeding
sections of each disease-specific chapter in Part 4 of this Handbook.

The need for vaccination, particularly for hepatitis B, measles, mumps, rubella,
varicella, diphtheria, tetanus and pertussis, should be assessed as part of any
pre-conception health check. Where previous vaccination history or infection is
uncertain, relevant serological testing can be undertaken to ascertain immunity to
hepatitis B, measles, mumps and rubella. Routine serological testing for pertussis
and varicella does not provide a reliable measure of vaccine-induced immunity,
although varicella serology can indicate whether previous natural infection has
occurred (see 4.22 Varicella). Influenza vaccine is recommended for any person
who wishes to be protected against influenza and is recommended for women
planning pregnancy. Those with risk factors for pneumococcal disease, including
smokers and Aboriginal and Torres Strait Islander women, should be assessed
for pneumococcal vaccination. Women who receive live attenuated viral vaccines
should be advised against falling pregnant within 28 days of vaccination.
Seasonal influenza vaccine is the only vaccine routinely recommended for

pregnant women. dTpa vaccine can also be given in pregnancy, as an alternative
to providing it immediately post-partum. Vaccination with dTpa during
pregnancy will provide timely protection against pertussis in both the mother
and her newborn child.
Many other inactivated vaccines are not routinely recommended during
pregnancy on precautionary grounds; however, there is no convincing evidence
that pregnancy should be an absolute contraindication to vaccination with
these vaccines. There is some evidence that fever per se is teratogenic; however,
in clinical studies most inactivated vaccines are not associated with increased
rates of fever in adults (as compared with placebo).13,14 Recommendations
regarding vaccine use in pregnancy are made where the benefits of protection
from vaccination outweigh the risks. Eliminating the risk of exposure to vaccinepreventable diseases during pregnancy (e.g. by changing travel plans, avoiding
high-risk behaviours or occupational exposures) is both an alternative and
complementary strategy to vaccination.
Live attenuated viral vaccines are contraindicated in pregnant women because
of the hypothetical risk of harm should vaccine virus replication occur in the
fetus. If a live attenuated viral vaccine is inadvertently given to a pregnant
woman, or if a woman becomes pregnant within 28 days of vaccination, she
should be counselled about the potential for adverse effects, albeit extremely
unlikely, to the fetus (see also 4.18 Rubella and 4.22 Varicella). There is, however,
no indication to consider termination of a pregnancy if a live attenuated vaccine
has been inadvertently given. The live attenuated yellow fever vaccine is not
recommended in pregnant women; however, where travel to a yellow fever risk
country is unavoidable, the risks and benefits of yellow fever vaccination, and
other strategies to mitigate the risk of acquiring yellow fever, should be discussed
(see 4.23 Yellow fever).
Inadvertent receipt of a vaccine contraindicated in pregnancy can be reported
to the Therapeutic Goods Administration (TGA). For mechanisms for reporting
to the TGA, see 2.3.2 Adverse events following immunisation. Post-marketing
studies of pregnancy outcomes following vaccine administration are important
to understand the safety profile of vaccines in this setting. For this reason some
vaccine manufacturers also operate pregnancy registries, specific for their
products, that will accept reports of vaccines administered during pregnancy; for
example, see information on the varicella vaccine registry in 4.22 Varicella.
Recommended for all pregnant

women at any stage of pregnancy,
particularly those who will be in the
second or third trimester during the
influenza season.
Influenza vaccine
Recommendation
dTpa can be given to pregnant
women in the third trimester as an
alternative to post-partum dTpa (if
a dose of dTpa has not been given in
the previous 5 years).
Not routinely recommended
Inactivated bacterial vaccines
Diphtheria-, tetanus-, and pertussiscontaining vaccines (dTpa, dT)
Cholera (oral) vaccine
Vaccines not routinely recommended in pregnancy
Recommendation
Inactivated viral vaccines
Vaccines routinely recommended in pregnancy
There are limited data on the safety of oral cholera vaccine in

pregnancy.19
(See 4.12 Pertussis for more details.)15
Tetanus- and diphtheria-containing vaccines have been used

extensively in pregnant women, with no increased risk of congenital
abnormalities in fetuses of women who were vaccinated during
pregnancy.16-18
Vaccination in the third trimester is an acceptable alternative to postpartum vaccination, for pregnant women who have not been given a
dTpa dose within the previous 5 years.15 Receipt of dTpa in the third
trimester of pregnancy may be preferred when the risk of the mother
and/or infant acquiring pertussis is high, such as for pregnant women
in close contact with infants. Vaccination during pregnancy has the
advantage of achieving more timely and high pertussis antibody
responses in the mother and infant after birth, as compared with
vaccination given post-partum or prior to conception.
Comments
There is evidence from clinical trial data and observational studies

that there is no increased risk of congenital defects or adverse effects
in the fetuses of women who are vaccinated against influenza in
pregnancy. Influenza immunisation protects the mother, as pregnancy
increases her risk of severe influenza, and also protects her newborn
baby in the first few months after birth (see 4.7 Influenza).
Comments
Table 3.3.1: R
ecommendations for vaccination in pregnancy (see also disease-specific chapters in Part 4)

13-valent pneumococcal conjugate

vaccine (13vPCV)
Meningococcal polysaccharide vaccine

(4vMenPV)
Meningococcal conjugate vaccines

(MenCCV or 4vMenCV)
Haemophilus influenzae type b (Hib)

vaccine
Can be given to pregnant women

at increased risk of meningococcal
disease who have not been
vaccinated with 4vMenPV in the
past 3 years (e.g. with asplenia),
or as post-exposure prophylaxis
in household contacts/cases of
meningococcal serogroup A, W135
or Y

at increased risk of meningococcal
disease (e.g. with asplenia) or
as post-exposure prophylaxis
in household contacts/cases of
meningococcal serogroup A, C, W135
or Y

at increased risk of Hib disease (e.g.
with asplenia)
Recommendation
No data are available. Vaccination during pregnancy has not been

evaluated, although is unlikely to result in adverse effects.
Limited available data suggest that it is unlikely that use of

meningococcal polysaccharide vaccine in pregnant women has
any deleterious effects on pregnancy outcomes.23,24 Where clinically
indicated, meningococcal polysaccharide vaccine can be given to
pregnant women, although 4vMenCV is preferred.22
There are limited data on the safety of meningococcal conjugate

vaccines in pregnancy.21 Where clinically indicated, meningococcal
conjugate vaccine can be given to pregnant women.22
Limited available data suggest that it is unlikely that use of Hib

vaccine in pregnant women has any deleterious effects on pregnancy
outcomes.20
Comments
Limited data are available.

Hepatitis A vaccine should only be given to pregnant women who are
non-immune and at increased risk for hepatitis A.27

Can be given to susceptible pregnant
women travelling to areas of
moderate to high endemicity or
those who are at increased risk of
exposure through lifestyle factors,
or where severe outcomes may be
expected (e.g. pre-existing liver
disease)
Comments
Recommendation
No data are available.26 Vaccination during pregnancy has not been

directly evaluated, although is unlikely to result in adverse effects.
Safe use in pregnancy has not been established.
Hepatitis A vaccine

travelling to endemic countries
where water quality and sanitation
is poor
Women of child-bearing age with known risk factors for IPD

(including smokers) should be vaccinated before pregnancy, according
to recommendations (see 4.13 Pneumococcal disease).
23vPPV has been administered in pregnancy in the context of clinical

trials25 with no evidence of adverse effects; however, data are limited.
Where clinically indicated, 23vPPV can be given to pregnant women.
Comments
Typhoid Vi polysaccharide vaccine
Q fever vaccine
23-valent pneumococcal polysaccharide

vaccine (23vPPV)
Can be given to pregnant women at
the highest increased risk of invasive
pneumococcal disease (IPD) (e.g.
with asplenia, immunocompromise,
cerebrospinal fluid leak) who have
not received 23vPPV in the past
5 years (and provided they have not
received 2 previous doses)
Recommendation

Rabies vaccine
Poliomyelitis vaccine (IPV)
Can be given to pregnant women for

whom this vaccine would otherwise
be recommended (e.g. post-exposure
prophylaxis).

high risk of poliovirus exposure (e.g.
travel to endemic countries)
Pregnancy is never a contraindication to rabies vaccination in

situations where there is a significant risk of exposure (related to
occupation or travel), or where there has been a potential exposure to
rabies virus, Australian bat lyssavirus or another bat lyssavirus.34,35
Limited available data suggest that it is unlikely that the use of rabies
vaccine in pregnant women has any deleterious effects on pregnancy
outcomes.30-33
IPV should only be given to pregnant women when clearly indicated.
Limited available data suggest that it is unlikely that use of

inactivated poliomyelitis vaccine in pregnant women has any
deleterious effects on pregnancy outcomes.26
JE infection is associated with miscarriage, and women who are at

high risk of JE should be assessed for the need for vaccination. Where
the risk of JE disease is high, pregnant women should be vaccinated
using the inactivated vaccine, JEspect (not Imojev, which is a live
attenuated vaccine).29

high risk of acquiring JE
Hepatitis B vaccine should only be given to pregnant women who are

non-immune and at increased risk for hepatitis B.28
Can be given to susceptible pregnant

women for whom this vaccine
would otherwise be recommended,
for example, as post-exposure
prophylaxis in a non-immune
pregnant woman with a significant
exposure to a HBsAg-positive source
Japanese encephalitis (JE) vaccine

(JEspect)
Hepatitis B vaccine
Comments
Recommendation
Not recommended
Recommendation
Not recommended
Human papillomavirus (HPV) vaccine
Live attenuated viral vaccines
Yellow fever vaccine
Recommendation
Contraindicated
Contraindicated
Recommendation
Contraindicated
Live attenuated bacterial vaccines
BCG vaccine
Oral typhoid vaccine
Japanese encephalitis (JE) vaccine

(Imojev)
Vaccines contraindicated in pregnancy
Recommendation
Vaccines not recommended in pregnancy

Women of child-bearing age should avoid pregnancy for 28 days after

vaccination.
There is only a hypothetical risk. There are currently no data available

regarding the use of this vaccine in pregnant or breastfeeding women.
Comments
There are limited data available (animal studies), suggesting no

increased occurrence of fetal damage with oral live attenuated
vaccine.41 Inactivated typhoid Vi polysaccharide vaccine is preferred
(see above).
There is only a hypothetical risk. BCG vaccine has not been shown to
cause fetal damage.40
Comments
Pregnant women should be advised against going to the rural areas

of yellow fever endemic areas. However, where travel to an at-risk
country is unavoidable, such women should be vaccinated.37,38 Yellow
fever vaccine has been given to a large number of pregnant women
with no adverse outcomes.39
Comments
In the event of pregnancy, completion of a 3-dose course of

vaccination should be deferred until after delivery.
Although HPV vaccination is not recommended during pregnancy,

evidence from clinical trials and limited data from observational
studies where HPV vaccine was inadvertently administered during
pregnancy, indicate that there is no increased risk of adverse effects on
the fetus.36
Comments
Recommendation
Contraindicated
Contraindicated
Contraindicated
Contraindicated
Measles-mumps-rubella (MMR)
vaccine
or
Measles-mumps-rubella-varicella
(MMRV) vaccine
Rotavirus vaccine
Varicella vaccine
Zoster vaccine
Vaccines contraindicated in pregnancy
There is only a hypothetical risk. Women of child-bearing age are

unlikely to be eligible for vaccination, as zoster vaccine is registered
for use in persons 50 years of age. If women of child-bearing age
have inadvertently been vaccinated, they should avoid pregnancy for
28 days after vaccination.

vaccination.
There is only a hypothetical risk. Congenital varicella syndrome has

not been identified in women who have been inadvertently vaccinated
with varicella vaccine in early pregnancy.45
Rotavirus vaccines are not registered or recommended for use in

adolescents or adults.
It is recommended practice to test all pregnant women for immunity

to rubella, and to vaccinate susceptible women as soon as possible
after delivery and check their serological status post vaccination.

vaccination.
There is only a hypothetical risk. Despite concerns that live attenuated

rubella vaccine virus might cause congenital abnormalities, rubella
vaccine (either monovalent or as MMR) has been given to pregnant
women (usually inadvertently) without harm to the fetus.42,43 Even
though rubella vaccine virus can infect the fetus, even for vaccine
given in early pregnancy, there is no evidence that it causes congenital
rubella syndrome in infants born to susceptible mothers.44 Receipt
of rubella vaccination during pregnancy is not an indication for
termination.43
Comments
Pooled or hyperimmune
immunoglobulins
There is no known risk to the fetus from passive immunisation of
pregnant women with immunoglobulins.
Can be used post exposure in

susceptible pregnant women
exposed to: measles, hepatitis A,
hepatitis B, rabies, Australian bat
lyssavirus, or varicella viruses, or
tetanus
For more details, see Part 5 Passive immunisation and relevant diseasespecific chapters in Part 4.
Immunoglobulins for use as pre- or post-exposure prophylaxis

Contact between pregnant women and persons who have recently received live vaccines
Household contacts of pregnant women should be age-appropriately vaccinated.

It is safe to administer measles-, mumps-, rubella- and varicella-containing
vaccines, zoster vaccine and rotavirus vaccine to the contacts of pregnant
women. There is no risk of transmission of measles, mumps or rubella vaccine
viruses from vaccinated household contacts. There is an almost negligible risk
of transmission of varicella-zoster vaccine virus (from persons vaccinated with
varicella or zoster vaccines); however, vaccine recipients with a varicella-like
rash should be advised to cover the rash if in contact with a pregnant woman.
Although there is a very small possibility of transmission of the rotavirus vaccine
viruses to pregnant contacts, the benefit of immunising infants to protect against
rotavirus disease and, in turn, reduce the risk of rotavirus in household contacts,
far outweighs any theoretical risk (see 4.17 Rotavirus).
Use of immunosuppressive therapy during pregnancy
Certain immunosuppressive medications given for management of a medical

condition in a woman during pregnancy (e.g. biological disease modifying
anti-rheumatic drugs [bDMARDs]) may cross the placenta and be detectable
in the infant, particularly if given during the third trimester.46-48 In this setting,
administration of live attenuated vaccines in the first few months of the infants
life, particularly BCG vaccine, is not recommended.49 (See also 4.20 Tuberculosis.)
This is because of the risk that the infants immune response to vaccination may
be reduced and potentially associated with increased vaccine virus/bacteria
replication and related adverse effects. Although no specific time intervals
are indicated, withholding BCG vaccine until the infant is 6 months of age is
prudent.50 Although there is some theoretical concern that a risk also applies
to the administration of rotavirus vaccines, there are currently no data to
substantiate this.
Inactivated vaccines should be administered to these infants according to the
recommended schedule. However, immune responses may be suboptimal.
Additional inactivated vaccine doses may be required; expert advice should be
sought regarding this.
Breastfeeding and vaccination

Vaccination is rarely contraindicated in breastfeeding women. The rubella
vaccine virus may be secreted in human breast milk and there has been
documented transmission to breastfed infants. However, where infection has
occurred in an infant, the symptoms have been absent or mild.51-53 Infants born
to mothers who are hepatitis B surface antigen (HBsAg)-positive can also be
breastfed, provided the infant is appropriately immunised at birth. Although
studies have indicated the presence of hepatitis B virus (HBV) in the breast
milk of mothers with HBV infection, breastfeeding poses no additional risk of
virus transmission, compared with formula feeding, in vaccinated infants.54
Administration of yellow fever vaccine to breastfeeding women should be
avoided, except in situations where the risk of acquiring yellow fever is high,
and/or travel cannot be avoided or postponed.55,56 While extremely rare, there
have been several case reports of probable transmission of the yellow fever
vaccine virus via breast milk.55,56 For most vaccines, the immune response to
vaccination of infants in relationship to breastfeeding has been studied and taken
into account. In general, breastfeeding does not adversely affect immunisation,
and breastfeeding is not a contraindication to the administration of any vaccines
recommended in infants.
Preterm infants
Preterm (premature) infants are defined as those born at <37 weeks gestational
age. Prematurity, particularly extreme prematurity (<28 weeks gestational age)
can place children at increased risk of vaccine-preventable diseases.57-59 However,
despite their immunological immaturity, preterm infants generally respond
satisfactorily to vaccines.60-62 Provided they are medically stable and there are no
contraindications to vaccination, preterm infants should be vaccinated according
to the recommended schedule at the usual chronological age, without correction
for prematurity.63-65
The following recommendations are specific for preterm infants. The childs birth
weight, precise gestational age and the presence of a chronic medical condition(s)
need to be considered.
Pneumococcal vaccines
All preterm infants born at <28 weeks gestation are recommended to be given
4 doses of 13-valent pneumococcal conjugate vaccine, at 2, 4, 6 and 12 months
of age. A single booster dose of 23-valent pneumococcal polysaccharide vaccine
at 45 years of age is also recommended (see 4.13 Pneumococcal disease and Table
2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in
children with a medical condition(s) associated with an increased risk of IPD, presenting
at age <2 years). Children who were born at <28 weeks gestation but who do not
have a chronic medical condition(s) that places them at ongoing increased risk
of invasive pneumococcal disease (IPD) (see 4.13 Pneumococcal disease, List 4.13.1
Conditions associated with an increased risk of IPD in children and adults, by severity
of risk), and who have received the additional pneumococcal vaccine doses to
age 5 years recommended above, do not need further pneumococcal vaccine

Immunisation has been associated with an increased risk of apnoea in preterm

infants vaccinated in hospital, particularly those still requiring complex medical
care and/or with an existing history of apnoea. Although in this setting, apnoea
is generally self-limiting, measures to manage this anticipated AEFI should be
taken.66-68 Specifically, hospitalised preterm infants should be monitored for
apnoea or bradycardia for up to 48 hours post vaccination.68,69 If there is a history
of apnoea post vaccination, consideration should be given to administering
future immunisations under medical supervision.70,71 Vaccination has not been
associated with an increased risk of sudden infant death syndrome (SIDS).72,73
doses after age 5 years. However, all children and adults who have chronic lung
disease, or certain other chronic medical conditions, whether related to preterm
birth or not, should also receive additional pneumococcal vaccine doses up to and
beyond the age of 5 years (see 4.13 Pneumococcal disease).
Hepatitis B vaccine
Low-birth-weight preterm newborn infants do not respond as well to hepatitis

B-containing vaccines as full-term infants.69,74,75 Thus, for low-birth-weight
infants (<2000g) and/or infants born at <32 weeks gestation (irrespective of
weight), who are born to mothers who are HBsAg-negative, it is recommended
to give hepatitis B vaccine at birth, followed by 3 doses of a hepatitis
B-containing vaccine, at 2, 4 and 6 months of age, with a booster dose at
12 months of age. The booster dose can be administered without measuring
the antibody titre following the primary series. Alternatively, if an anti-HBs
titre is measured, this should be done a minimum of 1 month after the 6-month
dose, and if the anti-HBs titre is <10mIU/mL, a booster dose should be given
(see 4.5 Hepatitis B). Preterm infants born to HBsAg-positive mothers should be
given hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) after birth as
specified in 4.5 Hepatitis B.
Influenza vaccine
Preterm infants have a high rate of underlying medical conditions particularly

respiratory, cardiac or neurological disease that increase the risk of
complications from influenza.76 In accordance with the recommendations for
use of influenza vaccine, it is particularly important to assess preterm infants
for the presence of underlying conditions that make them eligible for influenza
vaccination. Vaccination should be provided annually from 6 months of age.
Two vaccine doses, at least 4 weeks apart, are required in the first year that
influenza vaccine is received (see 4.7 Influenza).
Rotavirus vaccine
Preterm infants, including medically stable hospitalised infants, can receive

the rotavirus vaccine at chronological age without correction for prematurity.
Strict upper age limits for vaccine administration apply and depend on which
rotavirus vaccine is administered (see 4.17 Rotavirus).
Hib vaccine
If a PRP-OMP Hib vaccine is used for primary immunisation of an extremely

preterm low-birth-weight infant (<28 weeks gestation and/or <1500g birth
weight), a total of 3 (not 2) primary doses of vaccine should be given. Thus, the
schedule should include 4 doses of a Hib-containing vaccine (either PRP-OMP or
PRP-T-containing), given at 2, 4, 6 months and a booster dose at 12 months of age
(see 4.3 Haemophilus influenzae type b).
3.3.3 Vaccination of immunocompromised persons

A person can be immunocompromised due to disease and/or medical
treatment. Vaccination of immunocompromised persons presents numerous
challenges. The immune protection attained from previous immunisation
may be diminished; the response to vaccines administered in the setting of
immunocompromise may be reduced, with additional booster vaccine doses
required; the risk of vaccine-preventable diseases and/or their complications
may be increased; and the risk of adverse events from live vaccines may be
increased. Degrees of immunocompromise vary from insignificant to profound,
and this, together with the risk of acquiring vaccine-preventable disease, should
be taken into account when considering a vaccination schedule.
Many vaccine-preventable diseases are associated with an increased risk of

morbidity and mortality in immunocompromised persons. Two important
examples are influenza and invasive pneumococcal disease (IPD). Annual
influenza vaccination should be given to all immunocompromised persons
6 months of age (see 4.7 Influenza). Immunocompromised persons may
also require additional doses of pneumococcal vaccines; the timing, number
of doses and type of vaccine(s) vary depending on age and the underlying
risk for IPD (see 4.13 Pneumococcal disease). These, and other specific vaccine
recommendations, are discussed in more detail below.
vaccine for the first time are recommended to receive 2 vaccine doses, at least
4 weeks apart, and 1 dose annually thereafter (see 4.7 Influenza). Where it is

When considering vaccination of persons on immunosuppressive therapy, it is

particularly important to consider a number of factors, including the biologic
target of the medication being used (mechanism and duration of effect on the
immune system) as well as the consequence of using combination therapies
(e.g. prednisolone and methotrexate), which can contribute to the nature,
extent and length of immunocompromise. It is also important to know the
anticipated duration of immunocompromise, whether due to therapy or the
underlying disease (see also Immunocompromise associated with corticosteroid
administration below). In some instances, additional booster doses of vaccines
may be required to optimise protection in immunocompromised persons
(e.g. pneumococcal vaccines at diagnosis of haematological malignancy).
To determine the need for booster doses, it may be useful to measure postvaccination antibody titres in selected groups in some circumstances, such as
for adults or children who have received haematopoietic stem cell transplants
(see Haematopoietic stem cell transplant recipients below). Reliable serological
testing is not readily available and/or validated to measure vaccine-induced
immunity for all vaccines, and, in addition, results should be interpreted using
standardised serological correlates. (See also 2.1.5 Catch-up, Use of serological
testing to guide catch-up vaccination.) Expert advice should be sought if
required.
known that a new influenza vaccine strain is circulating in the community to

which cross-protective immunity in the population is low (such as in the setting
of an influenza pandemic), it may be appropriate that immunocompromised
persons receive 2 doses of inactivated influenza vaccine, a minimum of 4 weeks
apart, to achieve an optimal immune response. For example, in the 20092010
H1N1 global influenza pandemic it was shown that seroconversion to influenza
vaccination in immunocompromised adolescents and adults was improved
following receipt of 2 vaccine doses.77 Further information and annual influenza
vaccine recommendations are available on the Immunise Australia website
(www.immunise.health.gov.au).
The recommendations in this section for the use of vaccines in
immunocompromised persons have been divided where applicable into
paediatric (018 years) and adult (19 years) recommendations. This distinction
has been made on the basis of scientific evidence, where available, and to assist in
vaccine delivery in paediatric and adult special risk settings.
Immunocompromise associated with corticosteroid administration

The dose and duration of therapy with corticosteroids determines the impact
on the immune system. In adults, daily doses of oral corticosteroids in excess of
60mg of prednisolone (or equivalent) for more than 1 week are associated with
significant immunocompromise. In children, doses in excess of either
2mg/kg per day for more than 1 week or 1mg/kg per day for more than
4 weeks are associated with significant immunocompromise. Live attenuated
vaccines are generally contraindicated in such persons (see also below). In
addition, for both children and adults, even lower doses may be associated with
some impairment of the immune response.78 It is also important, once treatment
with corticosteroids is ceased, to assess whether the person has other underlying
immunocompromising disease or is receiving other immunosuppressive therapy
that may influence decisions about whether vaccines, particularly live vaccines,
can be given.
For adults treated with systemic corticosteroids in excess of 60mg per day for
more than 1 week, live attenuated viral vaccines (such as MMR, MMRV, zoster,
varicella and yellow fever vaccines) should be postponed until at least 1 month
after treatment has stopped.
Children receiving >2mg/kg per day or 20mg per day in total of prednisolone
(or equivalent) for more than 1 week should not receive live attenuated vaccines
until after corticosteroid therapy has been discontinued for at least 1 month.
Children on daily doses of 2mg/kg per day of systemic corticosteroids for
less than 1 week, and those on lower doses of 1mg/kg per day or alternateday regimens for periods of up to 4 weeks, may be given live attenuated viral
vaccines. Some experts suggest withholding lower doses of steroids 2 to 3 weeks
prior to vaccination with live viral vaccines if this is possible.79,80
Use of live viral or live bacterial vaccines in immunocompromised persons

There is a risk that the administration of live vaccines to immunocompromised
persons may result in adverse events or vaccine-related disease due to
unchecked infection (replication) of the vaccine virus or bacteria. This is
particularly so for measles-, mumps-, rubella-81,82 and VZV-containing
(varicella and zoster) vaccines 83 and for bacille Calmette-Gurin (BCG)
vaccine.49,84 However, the risk of disease varies by vaccine and by individual.
Caution is required for vaccination in the setting of immunocompromise,
and in significantly immunocompromised persons most live vaccines are
contraindicated.
The following is a list of current recommendations for use of live vaccines in
immunocompromised persons.
Tuberculosis vaccine (BCG) is always contraindicated.
Rotavirus, MMR and varicella vaccines, but not the combined MMRV
vaccine, may be given to children and adults with HIV infection who are
asymptomatic or to those persons with an age-specific CD4+ count of 15%
(see HIV-infected persons below).
Zoster vaccine is not recommended for adults with AIDS or symptomatic
HIV infection. However, adults with asymptomatic HIV infection may be
considered for vaccination on a case-by-case basis after seeking appropriate
specialist advice (see 4.24 Zoster).
Immunocompetent persons who anticipate alteration of their immunity
because of their existing illness can be given zoster vaccine on a case-by-case
basis after seeking appropriate specialist advice (see 4.24 Zoster).
Immunocompromised travellers should not receive oral typhoid vaccines.
Use inactivated parenteral typhoid Vi polysaccharide vaccine instead (see
4.21 Typhoid).

Live vaccines, such as MMR- and VZV-containing (varicella and zoster)

vaccines, should not be given to persons with severe immunocompromise.
Severely immunocompromised persons include those who have active
leukaemia or lymphoma, generalised malignancy, aplastic anaemia,
graft-versus-host disease or congenital immunodeficiency. Others in
this category include persons who have received recent chemotherapy,
persons who have had solid organ or bone marrow transplants (within
2 years of transplantation) or transplant recipients who are still taking
immunosuppressive drugs, or others on highly immunosuppressive therapy,
including high-dose corticosteroids (see above). Dependent on their age,
persons infected with human immunodeficiency virus (HIV) with CD4+ cell
counts of <15%, history of an acquired immunodeficiency syndrome (AIDS)defining illness, or clinical manifestations of symptomatic HIV are considered
to have severe immunocompromise (see also Table 3.3.4).
Yellow fever vaccine is generally contraindicated in immunocompromised

travellers going to yellow fever endemic countries. The vaccine can, however,
be considered on a case-by-case basis, including in persons with HIV (see
4.23 Yellow fever).
If there is uncertainty around the level of immunocompromise and when vaccine
administration may be safe, this should be discussed with the treating physician
and expert advice should be sought (see also Immunocompromise associated
with corticosteroid administration above).
Household contacts of immunocompromised persons

To best protect immunocompromised persons, whether adults or children, their
household and other close contacts should be fully vaccinated according to
current recommendations. Annual influenza vaccination is recommended for
all household contacts (6 months of age) of immunocompromised persons.
Assessment of the need for household contacts of immunocompromised persons
to receive pertussis-containing and/or varicella vaccines is also very important
(see 4.12 Pertussis and 4.22 Varicella).85-87
The use of live attenuated viral vaccines in contacts of immunocompromised
persons (MMR, MMRV, varicella and rotavirus vaccines, where indicated) is
safe, and strongly recommended to reduce the likelihood of contacts infecting
the immunocompromised person. Persons 50 years of age who are household
contacts of an immunocompromised person are also recommended to receive
zoster vaccine. Although there is no risk of transmission of the MMR vaccine
viruses, and an almost negligible risk of transmission of varicella-zoster vaccine
virus (from varicella or zoster vaccine), there is a small risk of transmission of the
rotavirus vaccine virus. Hand washing and careful disposal of soiled nappies is
recommended to minimise transmission. Immunocompromised persons should
avoid contact with persons with varicella and herpes zoster, where possible. (See
also 4.9 Measles, 4.17 Rotavirus, 4.22 Varicella and 4.24 Zoster).
Oncology patients
Paediatric and adult patients undergoing cancer chemotherapy who have not completed a
primary vaccination schedule before diagnosis
Live vaccines, including BCG, MMR, zoster and varicella vaccines, are
contraindicated in cancer patients receiving immunosuppressive therapy and/or
who have poorly controlled malignant disease. These vaccines are recommended
to be administered to seronegative persons at least 3 months after completion
of chemotherapy, provided the underlying malignancy is in remission.88
Administration of live attenuated viral vaccines (MMR-containing or varicellacontaining vaccines) should be deferred if blood products or immunoglobulins
have been recently administered (see Table 3.3.6 Recommended intervals between
either immunoglobulins or blood products and MMR, MMRV or varicella vaccination).
Influenza vaccination is recommended annually in all cancer patients aged

6 months. All immunocompromised persons, irrespective of age, who receive
influenza vaccine for the first time are recommended to receive 2 vaccine doses,
at least 4 weeks apart, and 1 dose annually thereafter.
Persons receiving chemotherapy may receive inactivated vaccines (e.g. 13vPCV,
hepatitis B) according to a routine or catch-up vaccination schedule. The immune
response may be suboptimal, but the vaccines are safe to administer.
Vaccines should not be administered during times of severe neutropenia
(absolute neutrophil count <0.5x109/L), to avoid precipitating an acute febrile
episode.
Persons with underlying haematological malignancies (such as multiple
myeloma, Hodgkins lymphoma, non-Hodgkins lymphoma, chronic
lymphocytic leukaemia) are recommended to receive pneumococcal vaccination,
due to the increased risk of invasive pneumococcal disease (IPD).89 Newly
diagnosed children or adults who have not previously received a dose of 13vPCV
are recommended to receive at least one 13vPCV dose, depending on age, and
should subsequently receive 23vPPV. These vaccines should be administered
as early as possible after diagnosis, according to the persons age and previous
vaccination history.90-93 See 4.13 Pneumococcal disease for details.
Any deviations from these guidelines should be discussed with an oncologist.
The majority of the following vaccines may be administered without checking

antibody titres beforehand, and can be given at the same time.
The following schedule of booster vaccination is recommended if the person is
well and in remission 6 months after chemotherapy:
single dose of DTPa-containing vaccine if <10 years of age; use either dT or
reduced antigen content dTpa if 10 years of age
single dose of MMR, IPV, hepatitis B vaccines
single dose of 13vPCV (if previous age-appropriate dose(s) not received; see
4.13 Pneumococcal disease)
23vPPV dose(s) (following 13vPCV, and as per 4.13 Pneumococcal disease)
single dose of Hib vaccine (if either <5 years of age or if 5 years of age with
asplenia, see Table 3.3.5)
single dose of MenCCV (or 4vMenCV for persons with asplenia,
see Table 3.3.5)
4vHPV vaccine: if >9 years of age, single dose if previously completed a
primary course; 3-dose schedule if not previously received (schedule 0, 2
and 6 months) (see 4.6 Human papillomavirus)

Paediatric and adult patients with cancer who have completed cancer therapy and who
completed a primary vaccination schedule before diagnosis
varicella vaccine: persons who are seronegative to varicella-zoster virus

(VZV) should receive a 2-dose schedule of varicella vaccine, at least 6 months
after chemotherapy has ceased (see 4.22 Varicella).
Measles and rubella antibody status should be checked 6 to 8 weeks after
vaccination with MMR or MMRV vaccine. Persons who have not seroconverted
should receive a further dose.
Administration of live attenuated viral vaccines (MMR-containing or varicellacontaining vaccines) should be deferred if blood products or immunoglobulins
have been recently administered (see Table 3.3.6 Recommended intervals between
either immunoglobulins or blood products and MMR, MMRV or varicella vaccination).
Solid organ transplant recipients

For solid organ transplant (SOT) recipients, depending on the transplanted
organ, and to prevent rejection, variable doses of immunosuppressive agents
are required and may influence the effectiveness of vaccines. Where possible,
children undergoing solid organ transplantation should be vaccinated well
before transplantation. Inactivated vaccines can be administered safely after
transplantation, but are usually administered from 6 months after transplantation
to maximise the immune response.94,95 Live vaccines are contraindicated in
most post-transplantation protocols due to concerns of disseminated infection,
although data in this population are limited.95-97 Recommended vaccinations for
child and adult SOT recipients are given in Table 3.3.2.
Yes (8 weeks
after 13vPCV)
23-valent
pneumococcal
polysaccharide
vaccine
(23vPPV)
Yes
dTpa for those

10 years of age
DTPa-containing
vaccine for children
<10 years of age
Yes
Diphtheria, tetanus, pertussis
Hib vaccine
Yes (aged
6 weeks)
13-valent
pneumococcal
conjugate vaccine
(13vPCV)
Yes, provided
dTpa has not
been given in
the last 10 years
Not indicated
Yes (8 weeks
after 13vPCV)
Yes
Yes, if not
previously
vaccinated
Yes
Yes (8 weeks
after 13vPCV)
Yes (aged
6 weeks)
If possible, complete vaccination before

transplantation.
The primary schedule should be completed before

transplantation.
Not indicated
Yes, provided
dTpa has not
been given in the
last 10 years
See also catch-up tables for children and adults in

2.1.5 Catch-up.
For recipients 10 years of age, not previously

vaccinated, give the 1st dose as dTpa, followed by
2 doses of dT. If dT is unavailable, complete
vaccination course with dTpa.
For recipients <10 years of age, not previously

vaccinated, give all 3 doses as DTPa-containing
vaccine.
Recommendations depend on age. See 4.13

Pneumococcal disease and Table 2.1.11 Catch-up schedule
for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23)
in children with a medical condition(s) associated with an
increased risk of IPD, presenting at age <2 years.
Recommendations depend on age. See 4.13

Pneumococcal disease and Table 2.1.11 Catch-up schedule
for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23)
in children with a medical condition(s) associated with an
increased risk of IPD, presenting at age <2 years.
Comment
Yes (8 weeks
after 13vPCV)
Yes
Adult
(19 years)
Child
(018 years)
Child
(018 years)
Adult
(19 years)
Vaccines recommended after

transplantation, if not given
beforehand
Vaccines recommended before

transplantation
Streptococcus pneumoniae (pneumococcal disease)
Vaccine
Table 3.3.2: R
ecommendations for vaccinations for solid organ transplant (SOT) recipients96,98

Hepatitis A vaccine*
Hepatitis A
Hepatitis B vaccine
Hepatitis B
IPV
Poliomyelitis
Influenza vaccine
Influenza
Vaccine
Comment
Yes, depending
on serological
status
Yes (see
comments)
Yes
Yes
Adults who have received a routine course of polio

vaccination in childhood are recommended to receive
a booster every 10 years if they plan to travel to a
polio endemic area or have an occupational risk of
polio exposure (e.g. laboratory workers).
Recommended for all liver SOT recipients, or

transplant candidates or recipients with chronic liver
disease, or those chronically infected with either
hepatitis B or hepatitis C.
Accelerated schedules can be used (see Table 4.5.2

Accelerated hepatitis B vaccination schedules (for persons
with imminent risk of exposure)).
Yes, depending on Recommended for all seronegative SOT candidates.

serological status Immunogenicity is likely to be improved when
vaccination is administered before transplantation.
Yes (see
comments)
Yes, if
Yes, if
Yes, if
Yes, if
seronegative (see seronegative (see seronegative (see seronegative (see
comments)
comments)
comments)
comments)
Yes
Yes
Annual vaccination starting before transplantation for those 6 months of age. Two doses of influenza vaccine at least 4 weeks
apart are recommended for all SOT recipients receiving influenza vaccine for the first time. Influenza vaccine should be given
annually thereafter.
Adult
(19 years)
Child
(018 years)
Child
(018 years)
Adult
(19 years)

beforehand

transplantation
Yes
MMR vaccine
Yes
Measles, mumps and rubella
HPV vaccine
Yes, unless
2 previous
documented
doses
Yes
Yes, if 9 months Yes, if defined

of age with
risk factors (see
defined risk
comments)
factors (see
comments)
Quadrivalent
meningococcal
conjugate vaccine
(4vMenCV)*
Not indicated
Yes
Meningococcal C
conjugate vaccine
(MenCCV)
Contraindicated Contraindicated
The primary schedule should be completed before

transplantation provided the transplant candidate is
taking no immunosuppressive therapy and has no
underlying cellular immunodeficiency.
3-dose schedule of 4vHPV is recommended for those

aged >9 years. The routine schedule is 1st dose on day
0 (day of vaccination), 2 months, and 6 months (after
1st dose). Recommended in both females and males.
For more detail, see 4.6 Human papillomavirus.
Yes, if no
history of prior
immunisation
Yes, if no
history of prior
immunisation
If the 1st MenCCV dose is given before 12 months of

age, a 2nd dose should be given at least 8 weeks later.
Give 4vMenCV, if clinically indicated (see below),
once child is 12 months of age, and at least 8 weeks
has elapsed since receipt of last MenCCV dose.
4vMenCV as a 2-dose schedule is recommended as a
primary course of vaccination for those (9 months of
age) with complement component deficiencies (e.g.
C5-C9, properdin, Factor D, Factor H), functional
hyposplenism or anatomical asplenia (see Table
3.3.5 Recommendations for vaccination in persons with
functional or anatomical asplenia). Boosters of 4vMenCV
should be given every 5 years.
Not indicated
Comment
Yes, if 9 months Yes, if defined

of age with
risk factors (see
defined risk
comments)
factors (see
comments)
Yes
Adult
(19 years)
Child
(018 years)
Child
(018 years)
Adult
(19 years)

beforehand

transplantation
Neisseria meningitidis (meningococcal disease)
Vaccine

Yes, if nonimmune (see

comments)
Yes, if nonimmune (see

comments)
Contraindicated Contraindicated
Adult
(19 years)
Child
(018 years)
Child
(018 years)
Adult
(19 years)

beforehand

transplantation
The primary vaccination schedule should be

completed before transplantation, provided the
transplant candidate is taking no immunosuppressive
therapy and has no underlying cellular
immunodeficiency.
Confirm immunity with reliable history of varicella

disease and confident clinical diagnosis or serological
testing.
Comment
* Any transplant recipient who anticipates travelling may require additional vaccination, such as for hepatitis A
and meningococcal disease (see also 3.2 Vaccination for international travel).
Varicella vaccine
Varicella
Vaccine
Haematopoietic stem cell transplant recipients99,100

Haematopoietic stem cells are sourced from peripheral blood, bone marrow
or umbilical cord blood. Protective immunity to vaccine-preventable diseases
is partially or completely lost following either allogeneic or autologous stem
cell transplantation. Immunocompromise following allogeneic transplantation
is caused by a combination of the preparative chemotherapy given before
transplantation, graft-versus-host disease (GVHD), and immunosuppressive
therapy following transplantation. Persisting immunocompromise is common,
particularly in persons with chronic GVHD. Immunity is also impaired in
autologous HSCT recipients due to high-dose chemotherapy and radiotherapy,
but GVHD is not a concern as donor stem cells are derived from the transplant
recipient. In most cases, autologous HSCT recipients will recover their immunity
more quickly than allogeneic transplant recipients.
Separate vaccination schedules for autologous or allogeneic HSCT recipients
have not been supported in published guidelines because of limited data. For
practical purposes, the same schedule is recommended for these two groups,
regardless of donor source (peripheral blood, bone marrow or umbilical cord),
preparative chemotherapy (ablative or reduced intensity), or transplant type
(allogeneic or autologous).101,102
The immune response to vaccinations is usually poor during the first 6 months
after HSCT. Donor immunisation with hepatitis B, tetanus, Hib and
pneumococcal conjugate vaccines before stem cell harvesting has been shown to
elicit improved early antibody responses in HSCT recipients vaccinated in the
post-transplantation period.103-106 However, practical and ethical considerations
currently limit the use of donor immunisation.
Routine serological testing for several infectious agents and antibody levels
conferring protective immunity are poorly defined. For those vaccines that
are recommended for all HSCT recipients (tetanus, diphtheria, poliomyelitis,
influenza, pneumococcal, Hib), pre-vaccination testing is not recommended as
the response to a primary course of these vaccines is generally adequate. The
serological response to pneumococcal vaccine is less predictable. Pneumococcal
serology is only available in a few specialised laboratories and is not routinely
recommended. Serology before and approximately 4 to 6 weeks after vaccination
with the final dose of a hepatitis B vaccine course, and after MMR vaccine, is
recommended as antibody levels will determine the need for revaccination.102
Post-vaccination varicella serology using commercial assays is very insensitive
for vaccine-induced immunity (as compared with natural infection) and is not
recommended (see 4.22 Varicella).
A recommended schedule of vaccination is outlined in Table 3.3.3.

HSCT recipients with ongoing GVHD or remaining on immunosuppressive

therapy should not be given live vaccines. Chronic GVHD (cGVHD) is associated
with functional hyposplenism and therefore increases susceptibility to infections
with encapsulated organisms, especially Streptococcus pneumoniae. For persons
with cGVHD who remain on active immunosuppression, antibiotic prophylaxis
is recommended.99
Table 3.3.3: R
ecommendations for revaccination following haematopoietic
stem cell transplant (HSCT) in children and adults, irrespective of
previous immunisation history99,100,107-111
Vaccine
Months after HSCT

6
12
Comments
24
Streptococcus pneumoniae (pneumococcal disease)

13-valent
pneumococcal
conjugate
vaccine
(13vPCV)
Yes
Yes
Yes
Not needed
See 4.13 Pneumococcal disease
23-valent
pneumococcal
polysaccharide
vaccine
(23vPPV)
No
No
No
Yes (after
13vPCV)
See 4.13 Pneumococcal disease
Yes
Not needed
Yes
Not needed

Hib
Yes
Yes

DTPa-containing
vaccine for
children
<10 years of age
Yes
Yes
For recipients <10 years of age,

give all 3 doses as DTPa-containing
vaccine.
For recipients 10 years of age, give
the 1st dose as dTpa, followed by
2 doses of dT. If dT is unavailable,
complete vaccination course with
dTpa.
dTpa for those

10 years of age
Poliomyelitis
IPV
Yes
Yes
Yes
Not needed
A 3-dose course of inactivated

poliomyelitis vaccine is
recommended. This can be given
as DTPa-IPV or dTpa-IPV; see
above.
Yes
Yes
Yes
Not needed
A high-dose formulation (H-B-Vax

II dialysis formulation) is preferred.
Alternatively, give single strength
Hep B vaccine in each arm at each
dosing interval OR administer a
standard vaccination course, then
check HBsAb titres 48 weeks
following the last vaccine dose. If
titres are <10mIU/mL, repeat the
vaccination course.
Hepatitis B
Hepatitis B
vaccine
Influenza
Two doses of influenza vaccine at least 4 weeks apart are recommended for all HSCT recipients
receiving influenza vaccine for the first time, with the 1st dose given as early as 6 months after
transplant (see also in the introduction of 3.3.3 Vaccination of immunocompromised persons above),
then a single dose annually thereafter.
Vaccine
Months after HSCT

6
12
Comments
24
Neisseria meningitidis (meningococcal disease)

Meningococcal
C conjugate
vaccine
(MenCCV)
Yes
No
Yes
Not needed
If HSCT occurred prior to age

12 months, give up to 2 doses of
MenCCV, followed by 2 doses of
4vMenCV from 12 months of age
(see 4.10 Meningococcal disease).
Yes
Yes
Not
needed
Not needed
Two doses of 4vMenCV are

recommended for persons
12 months of age (see 4.10
Meningococcal disease).
(for those
<12 months
of age)
Quadrivalent
meningococcal
conjugate
vaccine
(4vMenCV)*
(for those
12 months
of age)
HPV vaccine
Individual recommendations for

HPV vaccination in those >9 years
of age should be determined by an
individual risk assessment (see 4.6
Human papillomavirus).
Measles, mumps and rubella

MMR vaccine
No
No
No
Yes, 1 or
2 doses
separated by
a minimum
interval of
4 weeks (see
comments)
Give only if the person is off

immunosuppressive therapy, with
no cGVHD and with reconstituted
cell-mediated immunity. Check
serology 4 weeks after 1st vaccine
dose. If there is no seroconversion,
repeat the dose.
No
No
No
Yes, 2 doses
separated by
a minimum
interval of
4 weeks (see
comments)
Give to a seronegative recipient

only if the person is off
immunosuppressive therapy, with
no cGVHD and with reconstituted
cell-mediated immunity.
Varicella
Varicella vaccine
* Any transplant recipient who anticipates travelling may require additional vaccination, such as
for meningococcal and hepatitis A disease (see also 3.2 Vaccination for international travel).

A 3-dose course
of 4vHPV is
recommended at
intervals of 0, 2 and
6 months. Specific
immunogenicity
data in this group are
not available; better
immune responses
may be expected
at >12 months post
transplantation when
a greater level of
immune reconstitution
has been achieved.
HIV-infected persons112
Vaccination schedules for HIV-infected persons should be determined by the
persons age, degree of immunocompromise (CD4+ count) and the risk of
infection (see Table 3.3.4 below). Children with perinatally acquired HIV differ
substantially from adults, as immunisation and first exposure to vaccine antigens
occurs after HIV infection, whereas in adults, most vaccines are inducing a
secondary boosted immune response. HIV-infected persons of any age whose
disease is well controlled on combination antiretroviral therapy (undetected or
low viral load with good preservation of CD4+ lymphocyte count) are likely to
respond satisfactorily to vaccines.
Table 3.3.4: C
ategories of immunocompromise in HIV-infected persons, based
on age-specific CD4+ counts and percentage of total lymphocytes113
Age
<12 months
15 years
6 years
Category
CD4+
per L
CD4+
per L
CD4+
per L
No evidence of
immunocompromise
1500
25
1000
25
500
25
Moderate
immunocompromise
7501499
1524
500999
1524
200499
1524
Severe
immunocompromise
<750
<15
<500
<15
<200
<15
HIV-infected persons should be vaccinated as described below.

Live attenuated vaccines
Rotavirus vaccines appear to be safe and immunogenic in HIV-infected

but clinically stable children,114,115 although data on their use are limited.
Vaccination can be given according to the routine schedule unless there is
severe immunocompromise. (See also 4.17 Rotavirus.)
MMR vaccine should be routinely administered to HIV-infected children
in a 2-dose schedule at 12 months and 18 months of age unless the child
has a CD4+ count of <750 per L.116-118 The serologic response is likely to
be greatly improved after the 2nd dose of MMR vaccine in HIV-infected
children,119,120 so consideration should be given to administering the 2nd
dose soon after the 1st dose (minimum interval between doses of 4 weeks)
to increase the likelihood of a serologic response to all three components.
This is particularly important if the child is travelling overseas or during
episodes of local measles virus transmission. Likewise, asymptomatic HIVinfected adults with a CD4+ count 200 per L who are seronegative to any
of the vaccine components should receive 1 or 2 doses of MMR vaccine,
depending on the number of vaccines received previously and evidence for

seroconversion. Administration of MMR vaccine does not have a significant
effect on the CD4+ count or viral load of HIV-infected adults.121 Measles may
cause severe disease in HIV-infected children, particularly those with a CD4+
count of <750 per L, in whom protection from vaccination may be reduced;
therefore, normal human immunoglobulin (NHIG) should be given as
post-exposure prophylaxis, regardless of vaccination status (see 4.9 Measles,
and Part 5 Passive immunisation).122 The combination MMRV vaccine is not
recommended for use in HIV-infected persons, due to a lack of data on its
use. (See also varicella text below.)
Varicella vaccine may be given to HIV-infected adults or children 12 months
of age who are asymptomatic, although data on efficacy and safety in HIVinfected persons is limited.123-125 Use of the monovalent varicella vaccine
(VV), given in 2 doses, at least 3 months apart, in children 12 months of age
with age-specific CD4+ count of 15% is recommended.126,127 The same 2-dose
VV strategy can be considered for HIV-infected adults who are varicellaseronegative and who have a CD4+ count of 200 per L.126 The combination
MMRV vaccine is not recommended for use in HIV-infected persons. (See
also 4.22 Varicella.)
Yellow fever vaccine can be administered to HIV-infected persons with CD4+

counts >200per L, who are at a recognised risk of exposure; however, this
should be discussed with the persons treating clinician.128 (See also 4.23
Yellow fever and 3.2 Vaccination for international travel.)
BCG vaccine should not be given to HIV-infected children or adults because
of the risk of disseminated BCG infection.129,130 (See also 4.20 Tuberculosis.)
Oral live attenuated typhoid vaccines should be avoided in HIV-infected
persons. Parenteral Vi polysaccharide typhoid vaccine should be used instead
(see 4.21 Typhoid).
Inactivated (non-live) vaccines
Diphtheria-tetanus-pertussis (DTPa/dTpa), Hib and IPV vaccines can be

given according to routine recommendations112,131 (see relevant diseasespecific chapters in Part 4).
The 4vHPV vaccine can be given to children (9 years of age) and adults with
HIV. It was safe and immunogenic in a small study of HIV1-infected men.132
HIV-infected persons should receive the routine course of 3 doses of 4vHPV
vaccine at times 0, 2 and 6 months. Vaccination is recommended for persons
in the age ranges for which the vaccine is registered (females aged 945 years

Zoster vaccine is not recommended for adults with AIDS or symptomatic

HIV infection. However, persons with asymptomatic HIV infection may
be considered for vaccination. Serological confirmation of previous VZV
infection must be obtained prior to vaccination. Zoster vaccine is only
registered for use in adults 50 years of age. (See also 4.24 Zoster.)
and males 926 years); use of HPV vaccine in males up to the age of 45 years
is unlikely to be associated with immunogenicity or adverse events that differ
from those observed in females. However, the benefit of HPV vaccination
is optimal when delivered to children or young adolescents prior to sexual
debut (see 4.6 Human papillomavirus).
Pneumococcal disease, both respiratory and invasive (IPD), is a frequent
cause of morbidity in HIV-infected children and adults (see List 4.13.1 in
4.13 Pneumococcal disease).133 Children should be vaccinated initially with
pneumococcal conjugate vaccine (13vPCV); the number of doses depends
on age at diagnosis and vaccination history (see Table 2.1.11 Catch-up
schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax 23) in children with
a medical condition(s) associated with an increased risk of IPD, presenting at age
<2 years). For children aged >5 years and adults, a single dose of 13vPCV
is recommended, followed by 23vPPV; repeat doses of 23vPPV are also
indicated. See 4.13 Pneumococcal disease for details.
Annual influenza vaccination is recommended in all HIV-infected
adults and children (6 months of age). In HIV-infected persons who are
immunocompromised and children <10 years of age, 2 doses, administered
a minimum of 4 weeks apart, are recommended the first time influenza
vaccine is given. HIV viral load may increase after influenza vaccination, but
CD4+ counts are unaffected and the benefits exceed the risk.134-137 (See also 4.7
Influenza.)
Hepatitis B is safe to use in HIV-infected persons, but the immunological
response may be diminished. Serological testing for evidence of previous
hepatitis B infection should be undertaken prior to commencing vaccination.
Limited studies in HIV1-positive adults have demonstrated an improved
and accelerated serological response to a vaccination schedule that consists
of 4 double doses, comprising two injections of the standard adult dose
(using Engerix-B) on each occasion, at times 0, 1, 2 and 6 months.138,139 HIVpositive children should receive 3 doses of hepatitis B vaccine using an adult
formulation (i.e. double the standard recommended dose for children).126,127
Antibody level should be measured at the completion of the vaccination
schedule; if the anti-HBs titre is <10mIU/mL, further doses are required (see
4.5 Hepatitis B).
Hepatitis A vaccines are immunogenic in most HIV-infected children,140 but are
only recommended for use in non-immune HIV-infected persons if they have
independent risk factors for acquisition of hepatitis A (see 4.4 Hepatitis A).
Parenteral Vi polysaccharide typhoid, inactivated Japanese encephalitis and
rabies vaccines are safe and can be used in HIV-infected persons, if indicated.
(See relevant disease-specific chapters in Part 4.)
Persons with functional or anatomical asplenia

Persons with an absent or dysfunctional spleen are at a life-long increased risk
of fulminant bacterial infection, most notably invasive pneumococcal disease
(IPD).89,141 Pneumococcal, meningococcal, Hib and influenza vaccination are
particularly recommended for all persons with asplenia, whether functional
or anatomical (such as splenectomy). Other vaccinations should be up to
date. Vaccines should be provided according to the persons age and previous
immunisation history, and immunisation status should be reviewed regularly.142
Specific vaccine recommendations for persons with asplenia are discussed below
and shown in Table 3.3.5.
In persons undergoing an elective splenectomy, vaccination should be completed,
where possible, 2 weeks before the scheduled operation date. In an unplanned
splenectomy, vaccination should commence approximately 1 week after the
splenectomy has occurred.143
Pneumococcal vaccination
Additional doses of pneumococcal vaccine are recommended for persons with

asplenia, depending on their age and previous immunisation history, as shown
in Table 3.3.5. Detailed information is provided in 4.13 Pneumococcal disease and
in Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV (Pneumovax
23) in children with a medical condition(s) associated with an increased risk of IPD,
presenting at age <2 years in 2.1.5 Catch-up.
A single dose of 13vPCV is recommended for asplenic older children and adults
who have not previously received any previous 13vPCV dose.146 This should
precede 23vPPV doses when possible. However, if 1 or more doses of 23vPPV have
previously been given, 13vPCV should be given at the next available opportunity,
and at least 1 year after the last 23vPPV dose. Subsequent doses of 23vPPV are
recommended, with a maximum of 3 doses in adulthood (age 18 years). Agespecific recommendations are discussed in 4.13 Pneumococcal disease.
Meningococcal vaccination
In infants aged <12 months, MenCCV is recommended: those <6 months of age
at diagnosis require 2 doses, given at least 8 weeks apart, and those 611 months
of age at diagnosis are recommended to receive 1 dose.

Children with splenic dysfunction should also be given antibiotic prophylaxis to

prevent bacterial infection, until at least 5 years of age.144,145 All asplenic persons
and/or their parents/carers should also be educated about the importance
of early investigation and treatment of febrile illnesses, including the use of
emergency antibiotics. Asplenic persons are recommended to wear a medical
alert. Vaccination cannot provide protection against all bacterial infections,
or even all pneumococcal serotypes that cause IPD, hence it is particularly
important that persons with asplenia are informed of the life-long increased risk
of severe bacterial infection, even if they have been appropriately vaccinated.
4vMenCV is recommended from 12 months of age, instead of the routine NIPscheduled MenCCV vaccination; a 2nd dose of 4vMenCV should be given at
least 8 weeks later. (See also 4.10 Meningococcal disease.) For adults and children
who are >12 months of age at diagnosis, 2 doses of 4vMenCV are recommended,
a minimum of 8 weeks apart. Subsequent booster doses of 4vMenCV are
recommended at 5-yearly intervals thereafter.
Hib vaccination
A single dose of Hib vaccine is recommended for asplenic persons who were not
vaccinated in infancy or who are incompletely vaccinated (see 4.3 Haemophilus
influenzae type b and Table 2.1.8 Catch-up schedule for Hib vaccination for children
<5 years of age in 2.1.5 Catch-up). Subsequent booster doses of Hib vaccine are not
required. Persons who have received all scheduled doses of Hib vaccine do not
require a booster dose before or after splenectomy.147
Influenza vaccination
Annual influenza vaccine is recommended in all persons from 6 months

of age (see 4.7 Influenza), particularly those who are immunocompromised.
Influenza infection can be complicated by secondary bacterial infections,
such as IPD. The influenza vaccine dose is dependent on previous influenza
vaccination history and age. (See also Table 4.7.1 Recommended doses of influenza
vaccine in 4.7 Influenza).
Table 3.3.5: R
ecommendations for vaccination in persons with functional or
anatomical asplenia
Age
Recommendations
Pneumococcal vaccines
6 weeks to <2 years
Give a 3-dose primary course of 13vPCV, with an additional

dose of 13vPCV at age 12 months.
See Table 4.13.1 and Table 2.1.11 for catch-up schedules.
2 to 5 years
If the primary course of PCV is incomplete or if the

recommended 13vPCV dose at age 12 months was not
received, give 1 or 2 doses of 13vPCV as per Table 4.13.2.
Give a single dose of 23vPPV at age 45 years.*
>5 to <18 years
If a 13vPCVdose has not previously been given, give a

single dose of 13vPCV, preferably prior to 23vPPV.*
If a dose of 23vPPV was received at age 45 years, give
another dose of 23vPPV 5 years later (at age 910 years).
If asplenia is newly diagnosed, give 2 doses of 23vPPV,
5 years apart (after 13vPCV; see above).
If a 13vPCV dose has not previously been given, give a
single dose of 13vPCV, preferably prior to 23vPPV.*
There is a maximum limit of 3 doses of 23vPPV during
adulthood (age 18 years). Give the 1st adult dose at
diagnosis (after 13vPCV: see above), or at least 5 years after
the last 23vPPV dose, whichever is later.
Meningococcal vaccines
6 weeks to <6
months
Give 2 doses of MenCCV, 8 weeks apart; then 2 doses of

4vMenCV, commencing at age 12 months (see below).
6 to 11 months
Give a single dose of MenCCV, then 2 doses of 4vMenCV,

commencing at age 12 months (see below).
12 months
Give 2 doses of 4vMenCV, 8 weeks apart.

Give a 4vMenCV dose every 5 years thereafter.

18 years
Age
Recommendations
Haemophilus influenzae type b (Hib) vaccine

6 weeks<5 years
Give the recommended course of Hib-containing vaccine,

or catch-up vaccination, according to Table 2.1.8 Catch-up
schedule for Hib vaccination for children <5 years of age.
Additional/repeat doses are not required.
5 years
If a Hib vaccine dose has not previously been given, or if the

primary course of Hib vaccine is incomplete, give a single
dose of Hib-containing vaccine.
If Hib vaccination is complete (as per children <5 years
above), additional/repeat doses are not required.
Influenza vaccine
6 months<3 years
Give 2 doses (0.25mL each), 1 month apart, in the first year

of vaccination.
Give 1 dose (0.25mL) in subsequent years.
39 years
Give 2 doses (0.5 mL each), 1 month apart, in the first year of

vaccination.
Give 1 dose (0.5 mL) in subsequent years.
>9 years
Give 1 dose.
* Whenever possible, 13vPCV dose(s) should precede the recommended 23vPPV dose(s). If
13vPCV follows 23vPPV, a minimum interval of 12 months between 13vPCV and the last
previous 23vPPV dose is recommended. The recommended minimum interval between a
13vPCV dose and a subsequent 23vPPV dose is 2 months. Also note that the recommended
minimum interval between any two 23vPPV doses is 5 years.
If asplenia is diagnosed at age 65 years (age 50 years for Indigenous adults), only a single
revaccination dose of 23vPPV is recommended.
The minimum interval between 4vMenCV and any previous MenCCV dose is 8 weeks.
Influenza vaccination is required annually. Two doses of influenza vaccine are not required
in the first year influenza vaccine is given, unless the asplenic person also has another
immunocompromising condition such as post SOT or HSCT.
In children >9 years and adults the dose of influenza vaccine is 0.5mL, if using intramuscular
vaccine. If aged >18 years, intradermal vaccination (Intanza: 0.1mL dose), may also be used (see
4.7 Influenza).
Persons with autoimmune diseases and other chronic conditions

Persons with autoimmune conditions, such as systemic lupus erythematosus
(SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS), are at higher
risk of infections, including vaccine-preventable diseases, with the associated
potential morbidity and mortality from infection. They are also at risk of
infection due to treatment with immunosuppressive agents such as bDMARDs
and targeted biological therapies.148 Some diseases can be reactivated during
therapy, so screening for infections such as hepatitis B and tuberculosis should be
undertaken prior to vaccination.149,150
Overall, theoretical concerns that vaccines exacerbate or cause autoimmune
diseases such as rheumatoid arthritis, type 1 diabetes and multiple sclerosis
have not been substantiated, with sporadic case reports not verified by larger
epidemiological studies.151-154 However, persons with a history of Guillain-Barr
syndrome (GBS) have an increased likelihood in general of developing GBS
again, and the chance of them coincidentally developing the syndrome following
influenza vaccination may be higher than in persons with no history of GBS.
A small increased risk of GBS was associated historically with one influenza
vaccine in the United States in 1976, but, since then, close surveillance has shown
that GBS has occurred at a very low rate of up to 1 in 1 million doses of influenza
vaccine, if at all.155
Hypopituitarism is not a contraindication to vaccination if the person is only

receiving physiological corticosteroid replacement, as this is not considered
immunosuppressive. If the person has been unwell and is on high-dose
corticosteroids for more than 1 week, the use of live attenuated vaccines should
be delayed for a minimum of 1 month.
Persons with metabolic diseases should be vaccinated using the routine schedule,
as vaccinations are generally considered safe in these persons.161 Influenza and
pneumococcal vaccines are recommended for those with metabolic disease. Any
individual concerns should be discussed with the treating metabolic physician.

In persons with autoimmune diseases and other chronic conditions,

there is potential for reduced immunogenicity of vaccines, due to both
immunosuppressive therapies and the underlying disease.156-158 The duration
of immunocompromise may be prolonged and caution must be taken when
considering live vaccines. Inactivated vaccines are recommended, to optimise
protection despite the potential for reduced immunogenicity in some people.
Clinical and laboratory measures of disease activity, and the choice, duration
and dose of immunosuppressive therapies, do not always predict who will
respond poorly to vaccination.157,159,160 In some instances, due to ongoing risk
of disease, additional vaccine doses may be required, such as pneumococcal
vaccine. Inactivated vaccines such as HPV and dTpa can be administered to
immunocompromised persons. Annual influenza vaccine is also important in
this population and should be administered annually (2 doses in the first year,
1 annually thereafter).
3.3.4 Vaccination of recent recipients of normal human

immunoglobulin and other blood products
The immune response to live parenteral viral vaccines (with the exception
of yellow fever and zoster vaccine) may be inhibited by normal human
immunoglobulin (NHIG). The interval recommended is dependent on the type
and half-life of the immunoglobulin administered (see Table 3.3.6 Recommended
intervals between either immunoglobulins or blood products and MMR, MMRV or
varicella vaccination).
Rotavirus vaccine may be administered at any time before or after, or
concurrently with, any blood product, including antibody-containing products,
following the routinely recommended schedule for rotavirus vaccine among
infants who are eligible for vaccination (see 4.17 Rotavirus). Minimal data are
available on the impact of blood products on the immune response to the vaccine
in these infants. Completing the full rotavirus vaccine series will optimise
protection.162
Zoster vaccine can be given at any time before or after administration of
immunoglobulin, or any antibody-containing blood product, because those
for whom it is registered (persons 50 years of age) are assumed to have had
a previous VZV infection and, therefore, already have serum antibody levels
comparable to those found in blood products (see 4.24 Zoster).
In persons with agammaglobulinaemia who are receiving monthly NHIG,
the use of live vaccines is not recommended as the immune response may be
inhibited. In addition, these people will have sufficient circulating antibody
(e.g. measles, varicella) from the NHIG to protect them in the case of exposure.
Inactivated vaccines are recommended as per the routine schedule; the response
may be suboptimal, but these vaccines are safe to administer.
Persons, who have received a blood transfusion, including mass blood
transfusions, do not require any past vaccinations to be repeated. However,
following the receipt of any blood product, including plasma or platelets, an
interval of 3 to 11 months should elapse, dependent on the blood product
transfused, before vaccination with an MMR, MMRV or varicella vaccine (see
Table 3.3.6 Recommended intervals between either immunoglobulins or blood products
and MMR, MMRV or varicella vaccination). An interval is suggested because there
may be low levels of antibodies present in the blood product that may impair the
immune response to the live vaccine.
Table 3.3.6: Recommended intervals between either immunoglobulins or blood

products and measles-mumps-rubella (MMR), measles-mumpsrubella-varicella (MMRV) or varicella vaccination*163
Immunoglobulin/blood product
Route
Dose
Interval
(months)
IU or mL
Estimated
mg IgG/kg
Negligible
Blood transfusion:

Washed RBCs
IV
10 mL/kg
RBCs, adenine-saline added
IV
10 mL/kg
10
Packed RBCs
IV
10 mL/kg
2060
Whole blood
IV
10 mL/kg
80100
Cytomegalovirus immunoglobulin
IV
3 mL/kg
150
HBIG as hepatitis B prophylaxis
IM
100 IU
400 IU
10
NHIG (intravenous) for ITP treatment
IV
400
NHIG (intravenous) for ITP treatment
IV
1000
10
NHIG (intravenous) for ITP or

Kawasaki disease treatment
IV
16002000
11
NHIG as hepatitis A prophylaxis
IM
(max. dose 15 mL)
Standard
IM
0.2 mL/kg
Immunocompromised
IM
0.5 mL/kg
Plasma or platelet products
IV
10 mL/kg
HRIG as rabies prophylaxis
IM
20 IU/kg
Replacement (or therapy) of immune

deficiencies (as NHIG [intravenous],
various doses)
IV
Rh (D) IG (anti-D)
IM
TIG (IM use) for tetanus prophylaxis
IM
ZIG as varicella prophylaxis
IM
5
6
160
22
300400
0
250 IU (given
within 24 hours
of injury)
500 IU (>24 hours
after injury)
200 IU (010 kg)
400 IU (1130 kg)
600 IU (>30 kg)
10
20
5
* Zoster vaccine can be given at any time before or after administration of immunoglobulin or any
antibody-containing blood product.

NHIG as measles prophylaxis:
0.5 mL (<25 kg)

1.0 mL (2550 kg)
2.0 mL (>50 kg)
3.3.5 Vaccination of persons with bleeding disorders

Persons who are receiving anticoagulant therapy may develop haematomas in
IM injection sites. The length of anticoagulant therapy should be clarified and
immunisation delayed if therapy is going to be of short-term duration. Unless
warfarin or low molecular weight heparin (LMWH) doses are known to be
stable, persons receiving anticoagulants should have appropriate levels checked
before vaccine administration, if possible. Intramuscular injections should be
deferred if the INR is >3.0 (warfarin) or the anti-Xa (LMWH) level 4 hours post
dose is >0.5 Units/mL.
If a person has haemophilia and is receiving clotting factor replacement or similar
therapy, IM vaccine administration should be conducted as soon as possible after
the medication is received.163 The site should not be rubbed post administration,
but firm pressure applied for approximately 510 minutes. Vaccine recipients
and/or carers should be informed about the possibility of haematoma formation.
Ice and immobilisation may be used in the case of a small haematoma. The
subcutaneous route could be considered as an alternative in a person with
haemophilia or on anticoagulant therapy; however, the intramuscular route is
preferred if that is the usual recommended mode of vaccine administration
seek expert advice. If a vaccine is administered subcutaneously, there may be
diminished immune response (e.g. requirement to check anti-HBs antibodies)
and additional vaccine doses may be required.164,165
3.3.6 Vaccination before or after anaesthesia/surgery

Recent or imminent surgery is not a contraindication to vaccinations, and
recent vaccination is not a contraindication to surgery (see 2.1.4 Pre-vaccination
screening). There are no randomised controlled trials providing evidence of
adverse outcomes with anaesthesia and surgery in recently vaccinated children.
It is possible that the systemic effects from recent vaccination, such as fever and
malaise, may cause confusion in the post-operative period. As the evidence
is limited, it is possible to administer vaccines as per the routine schedule,
or electively during a procedure for a person in a special risk group, if the
appropriate vaccine delivery safety mechanisms are in place.166
If elective surgery and anaesthesia are to be postponed, some guidelines
recommend postponing for 1 week after inactive vaccination and for 3 weeks
after live attenuated viral vaccination in children. Routine vaccination may be
deferred for 1 week after surgery.167
A person who receives any blood products during surgery will need to be
informed of the need to delay some vaccinations (see Table 3.3.6 Recommended
intervals between either immunoglobulins or blood products and MMR, MMRV or
varicella vaccination).
3.3.7 Vaccination of persons at occupational risk

Certain occupations, particularly those associated with healthcare, are associated
with an increased risk of some vaccine-preventable diseases.168,169 Furthermore,
some infected workers, particularly healthcare workers and those working in
early childhood education and care, may transmit infections such as influenza,
rubella, measles, mumps, varicella and pertussis to susceptible contacts, with
the potential for serious health outcomes. Many infectious diseases, measles in
particular, are highly infectious several days before symptoms become apparent.
Healthcare workers employed within the public health system should check
local state or territory healthcare worker immunisation requirements and the
necessary documentation required (see Appendix 1 Contact details for Australian,
state and territory government health authorities and communicable disease control).
Where workers are at significant occupational risk of acquiring a vaccinepreventable disease, the employer should implement a comprehensive
occupational vaccination program, which includes a vaccination policy, current
staff vaccination records, provision of information about the relevant vaccinepreventable diseases, and the management of vaccine refusal (e.g. reducing
the risk of a healthcare worker transmitting disease to vulnerable persons).
Employers should take all reasonable steps to encourage non-immune workers to
be vaccinated.
Standard precautions should be adopted where there is risk of occupational

exposure to blood and body fluids. Preventive measures include the appropriate
handling and disposal of sharps, the donning of gloves when handling body
fluids, and the use of goggles/face shields when splashes are likely.
If a non-immune person is exposed to a vaccine-preventable disease, postexposure prophylaxis should be administered where indicated (see relevant
disease-specific chapters in Part 4, and Part 5 Passive immunisation).

Current recommended vaccinations for persons at risk of occupationally acquired

vaccine-preventable diseases are listed in Table 3.3.7. In addition to the vaccines
specific to a persons occupation and work-related activities recommended here,
all adults should be up to date with routinely recommended vaccines, such as
dT-containing and MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.)
Table 3.3.7: R
ecommended vaccinations for persons at increased risk of certain
occupationally acquired vaccine-preventable diseases*
Occupation
Vaccine
Healthcare workers (HCW)

All HCW
Includes all workers and students directly involved in
patient care or the handling of human tissue, blood or
body fluids
Hepatitis B
Influenza
MMR (if non-immune)
Pertussis (dTpa)
Varicella (if non-immune)
HCW who work in remote Indigenous communities

or with Indigenous children in NT, Qld, SA and
WA, and other specified healthcare workers in some
jurisdictions
Vaccines listed for All

HCW, plus hepatitis A
HCW who may be at high risk of exposure to drugresistant cases of tuberculosis (dependent on state or
territory guidelines)
Vaccines listed for All

HCW, plus consider BCG
Persons who work with children

All persons working with children, including:
staff and students working in early childhood

education and care
correctional staff working where infants/
children cohabitate with mothers
Influenza
MMR (if non-immune)
Pertussis (dTpa)
school teachers (including student teachers)

outside school hours carers
child counselling services workers
youth services workers
Staff working in early childhood education and care
Vaccines listed for Persons

who work with children,
plus hepatitis A
Carers
Carers of persons with developmental disabilities
Hepatitis A
Hepatitis B
Influenza
Staff of nursing homes and long-term care facilities for

persons of any age
Influenza
MMR (if non-immune)
Occupation
Vaccine
Providers of home care to persons at risk of high

influenza morbidity
Influenza
Emergency and essential service workers

Hepatitis B
Influenza
Tetanus (dT or dTpa)
Armed forces personnel
Hepatitis B
Influenza
MMR (if non-immune)
Other vaccines relevant to
deployment
Staff of correctional facilities
Hepatitis B
Influenza
MMR (if non-immune)
Staff of detention and immigration centres
Hepatitis B
Influenza
MMR (if non-immune)
Laboratory personnel
Laboratory personnel handling veterinary specimens
or working with Q fever organism (Coxiella burnetii)
Q fever
Laboratory personnel handling either bat tissues or

lyssaviruses (including rabies virus and Australian bat
lyssavirus)
Rabies
Laboratory personnel routinely working with these

organisms:
Bacillus anthracis
Vaccinia poxviruses
Poliomyelitis virus
Salmonella enterica subspecies enterica
serovar Typhi (S.Typhi)
Yellow fever virus
Neisseria meningitidis
Japanese encephalitis virus
Anthrax
Smallpox
Poliomyelitis (IPV)
Typhoid
Yellow fever
Quadrivalent
meningococcal conjugate
vaccine (4vMenCV)

Police and emergency workers
Occupation
Vaccine
Persons who work with specific communities

Workers who live with, or make frequent visits to,
Hepatitis A
remote Indigenous communities in NT, Qld, SA and WA
Workers assigned to the outer Torres Strait Islands for
a total of 30 days or more during the wet season
Persons who work with animals

Veterinarians, veterinary students, veterinary nurses#
Influenza
Q fever
Rabies
Agricultural college staff and students (aged >15

years) exposed to high-risk animals#
Q fever
Abattoir workers and contract workers in abattoirs

(excluding pig abattoirs)
Livestock transporters
Sheep shearers and cattle, sheep and dairy farmers
Those culling or processing kangaroos or camels
Tanning and hide workers
Goat farmers
Livestock saleyard workers
Those handling animal products of conception
Q fever
Wildlife and zoo workers who have contact with atrisk animals, including kangaroos and bandicoots
Q fever
Persons who come into regular contact with bats

(both flying foxes and microbats), bat handlers, bat
scientists, wildlife officers, zoo curators
Rabies
Poultry workers and others handling poultry,

including those who may be involved in culling
during an outbreak of avian influenza, and swine
industry workers
Influenza
Other persons exposed to human tissue, blood, body fluids or sewage

Embalmers
Hepatitis B
Workers who perform skin penetration procedures

(e.g. tattooists, body-piercers)
Hepatitis B
Funeral workers and other workers who have regular

contact with human tissue, blood or body fluids and/
or used needles or syringes
Hepatitis B
Plumbers or other workers in regular contact with

untreated sewage
Hepatitis A
* Work activities, rather than job title, should be considered on an individual basis to ensure an
appropriate level of protection is afforded to each worker. In addition to providing protection
against certain vaccine-preventable diseases that persons in these occupations may be at

increased risk of acquiring, vaccination may also reduce the risk of transmission of diseases to
others with whom these persons are in contact.
In addition to the vaccines specific to a persons occupation and work-related activities
recommended here, all adults should be up to date with routinely recommended vaccines, such
as dT-containing and MMR vaccines (see also Table 2.1.12 in 2.1.5 Catch-up).
All adults born during or since 1966 should have evidence of either receiving 2 doses of MMR
vaccine or having immunity to measles, mumps and rubella. Adults born before 1966 are
considered to be immune due to extensive measles, mumps and rubella circulating widely in
the community during this period of time (see 4.9 Measles).
Carers of infants <6 months of age should be vaccinated against pertussis using dTpa
(see 4.12 Pertussis).
Persons with a repeated risk of exposure to, or working with large quantities or
concentrations of, Bacillus anthracis or Vaccinia cultures. For information regarding anthrax or
smallpox vaccination, contact the Office of Health Protection in the Australian Government
Department of Health, Canberra.
# Vaccines required in these occupations may depend on the animals with which the person
comes in contact.
3.3.8 Vaccination of migrants to Australia
Immunisation records, where available for refugees, are likely to have been given
to the nominated head of the household at the refugee camp health centre. The
Australian Government Department of Immigration and Citizenship (DIAC)
may in some circumstances be able to provide further information regarding
vaccine(s) administered to refugees before entering Australia, usually by
accessing an electronic health manifest. The World Health Organization website
(www.who.int/countries/en) lists immunisation schedules for most countries
and may provide some information regarding vaccine schedules.
If there is a valid record of vaccination from overseas, the history of previous
doses should be taken into account when planning a catch-up vaccination
schedule. However, some doses may be invalid, as the interval between doses
may be too short. This is often the case with oral poliomyelitis vaccines and
tetanus vaccines.
If a migrant/refugee has no valid documentation of vaccination, the standard
catch-up schedule should be commenced. Serological testing to determine the
need for specific vaccinations is not recommended in the absence of documented
vaccination.

Vaccination status is not routinely assessed in children and adults entering

Australia as refugees or migrants.170 Refugees or migrants may be incompletely
vaccinated according to the Australian schedule or have incomplete records of
vaccination.171 Most states and territories provide migrant/refugee immunisation
through hospital outpatient departments. Some clinics have also linked
families with local general practitioners who are of a similar ethnic and cultural
background to ensure ongoing follow-up and referral where required. In
addition, some local councils also provide a similar service.
If a child is 12 months of age, the 1st doses of DTPa, hepatitis B, IPV, MMR,
MenCCV, 13vPCV and Hib vaccines can be given at the same visit. For details,
see 2.1.5 Catch-up.
Migrant/refugee adults also need to be targeted for vaccination, especially
against rubella, using MMR vaccine. This is particularly important for women
of child-bearing age. Some refugees aged between 9 months and 54 years may
have been offered MMR as part of a pre-departure screening, but may require a
subsequent dose on arrival in Australia.170 It is important to take into account any
live attenuated viral vaccines that may have been administered as part of a predeparture screening, such as measles-containing vaccines or yellow fever vaccine
(especially in those persons arriving from central and northern African nations).
It is important to allow a minimum 4-week interval before administering any
other live attenuated viral vaccines.
All vaccines administered to children <7 years of age should be reported to the
Australian Childhood Immunisation Register (ACIR), including vaccinations
documented pre-arrival and those for children not enrolled with Medicare. ACIR
History Statements can be issued after documented overseas vaccination(s) have
been recorded on the ACIR. In addition, vaccinations provided to adolescents
via school-based programs are recorded by state/territory health authorities and
HPV vaccines should be recorded on the National HPV Vaccination Program
Register (NHVPR, or the HPV register) (see 2.3.4 Immunisation registers). It is
particularly important to ensure that families are provided with a written record
of all vaccines administered, and that all sources of vaccination records are
checked prior to vaccination, as multiple immunisation providers may have been
consulted after arrival.170,171
3.3.9 Vaccination of inmates of correctional facilities

Inmates of correctional facilities are at risk of acquiring influenza, hepatitis A and
hepatitis B, and should be vaccinated against these infections (see 4.4 Hepatitis A,
4.5 Hepatitis B and 4.7 Influenza).172-174 In addition, inmates of correctional facilities
should be up to date with routinely recommended vaccines for adults, such as
dT-containing and MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.)
3.3.10 Vaccination of men who have sex with men

Men who have sex with men are at risk of acquiring hepatitis A and hepatitis B,
and should be vaccinated against these infections (see 4.4 Hepatitis A and 4.5
Hepatitis B). Human papillomavirus vaccine may also be indicated (see 4.6
Human papillomavirus). In addition, men who have sex with men should be up to
date with routinely recommended vaccines for adults, such as dT-containing and
MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.)
3.3.11 Vaccination of persons who inject drugs

Persons who inject drugs are at risk of acquiring hepatitis A and hepatitis B,
and should be vaccinated against these infections (see 4.4 Hepatitis A and
4.5 Hepatitis B). In addition, persons who inject drugs should be up to date
with routinely recommended vaccines for adults, such as dT-containing and
MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.)
3.3.12 Vaccination of sex industry workers

Sex industry workers are at risk of acquiring hepatitis A and hepatitis B,
and should be vaccinated against these infections (see 4.4 Hepatitis A and
4.5 Hepatitis B). Human papillomavirus vaccine may also be indicated
(see 4.6 Human papillomavirus). In addition, sex industry workers should be
up to date with routinely recommended vaccines for adults, such as dTcontaining and MMR vaccines. (See also Table 2.1.12 in 2.1.5 Catch-up.)
References

PART 4 VACCINE-PREVENTABLE DISEASES

4.1 CHOLERA
4.1.1 Bacteriology
Vibrio cholerae is a motile, curved Gram-negative bacillus. Differences in the
O antigens have led to the description of more than 150 serogroups, only two
of which have been found to cause cholera. Cholera is caused by enterotoxinproducing V.cholerae of serogroups O1 and O139 (sometimes referred to as
the Bengal strain). Serogroup O1 includes two biotypes (classical and El Tor),
each of which includes organisms of Inaba, Ogawa and Hikojima serotypes.
The ability of V.cholerae to persist in water is determined by the temperature,
pH, salinity and availability of nutrients; it can survive under unfavourable
conditions in a viable dormant state.1 Transmission predominantly occurs when
people ingest faecally contaminated food or water.
4.1.2 Clinical features

Cholera is an acute bacterial infection that is generally characterised by the
sudden onset of painless, profuse, watery diarrhoea. In rare situations more than
half the severe cases will die. Mild cases also occur, as does subclinical infection.1
The cholera toxin does not produce intestinal inflammation. The cholera toxin
induces secretion of increased amounts of electrolytes into the intestinal lumen,
resulting in mild to severe dehydration and, in some cases, metabolic acidosis.
4.1.3 Epidemiology
The disease is usually transmitted via food and water contaminated with human
excreta. Seafood such as shellfish obtained from contaminated waters have
also been responsible for outbreaks.1 Cholera is a substantial health burden in
developing countries and is considered to be endemic in Africa, Asia, South
America and Central America.2 Cholera epidemics are common in circumstances
where food and water supplies can become contaminated, such as after natural
disasters and civil unrest.2 Cases of cholera in Australia (about 2 to 6 cases a
year) almost always occur in individuals who have been infected in endemic
areas overseas.3 However, the overall risk of cholera to travellers with access to
a safe water source and hygienic food preparation is considered to be low, even
when visiting countries where cholera is endemic. The risk of infection has been
estimated at 0.2 cases per 100 000 travellers from western countries, and the risk
of severe disease is considerably lower,4 although under-detection and underreporting of cholera among travellers is likely.2,4,5
In 1977, a locally acquired case led to the discovery of V.cholerae in some rivers
of the Queensland coast.6 Because of this, health workers should be aware that
sporadic cases of cholera may, on rare occasions, follow contact with estuarine
4.1.4 Vaccines
Dukoral CSL Limited and Crucell Sweden AB (inactivated wholecell V.cholerae O1, in combination with a recombinant cholera toxin
B subunit [rCTB]). Each 3.0mL liquid vaccine dose vial contains heat
and formalin-inactivated Inaba, Ogawa, classic and El Tor strains of
V.cholerae O1, 31.25x109 vibrios of each, combined with 1.0mg rCTB.
The buffer consists of a sachet of effervescent granules of anhydrous
sodium carbonate, sodium bicarbonate, anhydrous citric acid, sodium
citrate, saccharin sodium and raspberry flavour. This formulation
does not contain aspartame.
Trials of the oral cholera vaccine that contained inactivated whole-cell V.cholerae
O1 combined with rCTB have been performed mainly in Bangladesh and Peru.8-14
The large randomised controlled trial in Bangladesh included over 120000
children (aged 215 years) and women (aged >15 years), with up to 5 years
follow-up. About 13000 children and 8000 women received 3 doses of the study
vaccine. When cholera cases in all age groups were aggregated, the protective
efficacy of this vaccine (in a 3-dose regimen with inactivated Escherichiacoli as
control) was 85%, 6 months after the 3rd dose. The protective efficacy decreased
to 62% after 1 year, and to 57% after 2 years.8,10 On long-term follow-up (up to
5 years) no significant protective efficacy was observed beyond 2 years.8,14 The
efficacy of the vaccine was lower and waned more rapidly in children aged
25 years.14 In this age group, while the efficacy was 100% during the first
46 months after vaccination, it became non-significant in the latter half of the
1st year of follow-up (during a cholera epidemic), resulting in an overall efficacy
of 38% after 1 year; efficacy after 2 years was comparable. In contrast, for those
aged >5 years, the efficacy estimates were 76%, 78% and 63%, respectively, at
these three time points.8,9,14 The protective efficacy of the vaccine, over a 3-year
follow-up period, was not significantly different among those who received a
total of 2 doses versus those who received 3 doses (including all ages).8,9
A randomised controlled trial in Peru among military recruits aged 1645 years
found a vaccine efficacy of 86% against symptomatic cholera after 2 vaccine
doses.13 Another Peruvian household study showed an overall efficacy of 61%
PART 4 VACCINE-PREVENTABLE DISEASES 177
4.1 Cholera
waters. All cases of cholera reported since the commencement of the National
Notifiable Diseases Surveillance System in 1991 have been acquired outside
Australia, except for 1 case of laboratory-acquired cholera in 1996 and 3 cases in
2006.3,7 The 3 cases in 2006, reported in Sydney, were linked and associated with
consumption of raw imported whitebait.7 These patients had no history of recent
travel to known cholera-endemic areas.7
among 265-year olds,12 after a booster dose given 10 months after a 2-dose
primary series.12 A field effectiveness case-control study in Mozambique, during
a mass oral cholera vaccination program in an endemic population aged
2 years, found that 1 or more doses of the inactivated oral cholera vaccine was
78% protective (16 months after the 1st dose). The per-protocol effectiveness of
2 doses was 84% (0.54.5 months after the 2nd dose).15
There is structural similarity and immunologic cross-reactivity between the
cholera toxin and the heat-labile toxin of E. coli, which is often associated with
travellers diarrhoea. Therefore, it had been suggested that the rCTB-containing
vaccine may also provide protection against heat-labile toxin producing
enterotoxigenic E.coli (LT-ETEC). A study in short-term Finnish tourists16
showed that the inactivated oral cholera vaccine also provided a 60% reduction
in diarrhoea caused by LT-ETEC. A study in Bangladesh, an endemic area,
showed 67% protection against LT-ETEC for 3 months only.17 It can be expected
that the inactivated vaccine will reduce the proportion of travellers diarrhoea
that is caused by LT-ETEC. Approximately 30 to 40% of travellers to developing
countries contract travellers diarrhoea, with an average of 20% of cases caused
by LT-ETEC; hence, the 60% efficacy of the oral inactivated vaccine against
LT-ETEC could be expected to prevent up to 15% of travellers diarrhoea.18-20
However, in Australia this vaccine is only registered for the prevention of
cholera.
To date, there is no vaccine marketed in Australia to protect against infection
with V.cholerae O139. An oral killed whole-cell bivalent cholera vaccine (against
both serogroups O1 and O139) has been evaluated in Vietnam.21,22 More recently,
in India, an interim analysis of a cluster-randomised controlled trial reported a
protective efficacy of 67% against V.cholerae O1 after 2 years. Specific efficacy
against V.cholerae 0139 could not be assessed in this study, as cholera episodes
caused by this serogroup were not detected.23
4.1.5 Transport, storage and handling

Transport according to National vaccine storage guidelines: Strive for 5.24 Store at
+2C to +8C. Do not freeze. Protect from light.
Because the person to be vaccinated will be responsible for looking after the
vaccine following purchase, details of how it should be transported (from
pharmacy to home) and stored in the refrigerator (at home) must be carefully
explained.
4.1.6 Dosage and administration

Dukoral is an oral vaccine.
Food and drink should be avoided for 1 hour before and 1 hour after
administration of the inactivated cholera vaccine, as the vaccine is acid labile.
Children aged 26 years
Dukoral is administered orally. After dissolving the buffer granules in 150mL

of water, half the solution is then poured away and the entire contents of the
vaccine vial are mixed with the remaining 75mL for administration.
Adults and children aged >6 years

Two doses are required, given a minimum of 1 week and up to 6 weeks apart. If
the 2nd dose is not administered within 6 weeks, re-start the vaccination course.
Dukoral is administered orally. After dissolving the buffer granules in 150mL
of water, the contents of the vaccine vial are then added to the solution for
administration.
Co-administration with other vaccines

The inactivated oral cholera vaccine can be given with, or at any time before or
after, other travel vaccines, such as yellow fever or parenteral Vi polysaccharide
typhoid vaccines.
However, there should be an interval of at least 8 hours between the
administration of the inactivated oral cholera vaccine and oral live attenuated
typhoid vaccine (see 4.1.10 Precautions below).
4.1.7 Recommendations
Vaccination against cholera is not an official requirement for entry into any
foreign country.
Routine cholera vaccination is not recommended as the risk to travellers is
very low, despite the endemicity of cholera in some countries often visited by
Australians. Careful and sensible selection of food and water is of far greater
importance to the traveller than cholera vaccination.
Cholera vaccination should be considered for travellers at increased risk of
acquiring diarrhoeal disease, such as those with achlorhydria, and for travellers
at increased risk of severe or complicated diarrhoeal disease, such as those
with poorly controlled or otherwise complicated diabetes, inflammatory bowel
disease, HIV/AIDS or other conditions resulting in immunocompromise, or
significant cardiovascular disease.
Cholera vaccination should also be considered for travellers with considerable
risk of exposure to, or acquiring, cholera, such as humanitarian disaster workers
deployed to regions with endemic or epidemic cholera.
Dukoral is not registered for use in children aged <2 years and is not
recommended for use in this age group.
4.1 Cholera
Three doses are required, given a minimum of 1 week and up to 6 weeks apart.
If an interval of more than 6 weeks occurs between any of the doses, re-start the
vaccination course.
Booster doses
Booster doses are recommended for those who are at ongoing risk of exposure to
cholera.
Children aged 26 years who are at ongoing risk should receive a single booster
dose 6 months after completion of the primary course. If the interval between
primary immunisation and the booster dose is more than 6 months, primary
immunisation must be repeated.
Adults and children aged >6 years who are at ongoing risk should receive a
single booster dose up to 2 years after completion of the primary course. If the
interval between primary immunisation and the booster dose is more than
2 years, primary immunisation must be repeated.
4.1.8 Pregnancy and breastfeeding

Cholera vaccine is not routinely recommended for pregnant or breastfeeding
women.
There is limited information on the use of inactivated oral cholera vaccines
during pregnancy and breastfeeding.25
Refer to 3.3 Groups with special vaccination requirements, Table 3.3.1
Recommendations for vaccination in pregnancy for more information.
4.1.9 Contraindications
The only absolute contraindications to cholera vaccine are:
anaphylaxis following a previous dose of the vaccine
anaphylaxis following any vaccine component.
4.1.10 Precautions
Postpone administration of cholera vaccine during either an acute febrile illness
or acute gastrointestinal illness with persistent diarrhoea or vomiting, until
recovered.
Although the vaccine is not contraindicated in people who are
immunocompromised, including those with HIV infection, data on effectiveness
in this population are limited.
There should be an interval of at least 8 hours between the administration of the
inactivated oral cholera vaccine and oral live attenuated typhoid vaccine, as the
buffer in the cholera vaccine may affect the transit of the capsules of oral typhoid
vaccine through the gastrointestinal tract.
4.1.11 Adverse events
4.1.12 Public health management of cholera

Cholera is a notifiable and quarantinable disease in all states and territories
in Australia.
Further instructions about the public health management of cholera,
including management of cases of cholera and their contacts, should be
obtained from state/territory public health authorities (see Appendix 1
Contact details for Australian, state and territory government health authorities and
4.1.13 Variations from product information

The production information for Dukoral states that a booster dose is
recommended for adults 2 years after the completion of the primary vaccine
course if there is an ongoing risk of cholera. The ATAGI recommends that a
booster dose is also recommended 2 years after the completion of the vaccine
course for children >6 years of age if there is an ongoing risk of cholera.
References
4.1 Cholera
The inactivated oral cholera vaccine has a good safety profile, with similar
rates of adverse events reported among vaccine and placebo clinical trial
participants.12,16,25 Mild abdominal pain, discomfort and diarrhoea were reported
in post-marketing surveillance at a frequency of 0.11%.26
4.2 DIPHTHERIA
4.2.1 Bacteriology
Diphtheria is an acute illness caused by toxigenic strains of Corynebacterium
diphtheriae, a Gram-positive, non-sporing, non-capsulate bacillus. The exotoxin
produced by C.diphtheriae acts locally on the mucous membranes of the
respiratory tract or, less commonly, on damaged skin, to produce an adherent
pseudomembrane. Systemically, the toxin acts on cells of the myocardium,
nervous system and adrenals.

The incubation period is 2 to 5 days. The disease is communicable for up to
4 weeks, but carriers may shed organisms for longer. Spread is by aerosol
transmission or by direct contact with skin lesions or articles soiled by infected
persons. The disease can involve almost any mucous membrane. Pharyngeal
diphtheria, by far the commonest form of disease in the unimmunised, is
characterised by an inflammatory exudate that forms a greyish or green
membrane in the upper respiratory tract, which can cause acute severe
respiratory obstruction. Life-threatening complications from diphtheria toxin
include myocarditis and neuritis (usually affecting motor nerves). The casefatality rate in the last three decades has been reported as up to 16%.1 Diphtheria
antitoxin, which neutralises unbound toxin, was first used in the 1890s. Together
with antibiotics, antitoxin is the mainstay of treatment for diphtheria, but this
may not always be successful. The first death from diphtheria in Australia for
over 20 years occurred in 2011 in an unvaccinated person.2 Effective protection
against diphtheria is only achieved by active immunisation with diphtheria
toxoid-containing vaccines.1,3
4.2.3 Epidemiology
In the early 1900s, diphtheria caused more deaths in Australia than any other
infectious disease, but increasing use of diphtheria vaccines since World War II
has led to its virtual disappearance.4 The current epidemiology of diphtheria
in Australia is similar to that in other developed countries. Almost all recent
cases in the United Kingdom and the United States have been associated with
imported infections.5 In Australia, there have been two imported infections
identified, one case in 2001 and one imported infection in 2011, resulting in
two additional cases, including one death.2,6 The 2011 fatal case of pharyngeal
diphtheria occurred in an unvaccinated person infected by a friend who acquired
diphtheria in a less developed country.2
4.2.4 Vaccines
The acronym DTPa, using capital letters, signifies child formulations of

diphtheria, tetanus and acellular pertussis-containing vaccines. The acronym
dTpa is used for formulations that contain substantially lesser amounts
of diphtheria toxoid and pertussis antigens than child (DTPa-containing)
formulations; dTpa vaccines are usually used in adolescents and adults.
Diphtheria vaccination stimulates the production of antitoxin, which protects
against the toxin produced by the organism. The immunogen is prepared by
treating a cell-free preparation of toxin with formaldehyde, thereby converting it
into the innocuous diphtheria toxoid. Diphtheria toxoid is usually adsorbed onto
an adjuvant, either aluminium phosphate or aluminium hydroxide, to increase
its immunogenicity. Antigens from Bordetella pertussis, in combination vaccines,
also act as an effective adjuvant.
The circulating levels of antitoxin required for protection from diphtheria are
well described. Antitoxin levels of <0.01IU/mL are poorly protective, 0.01
to 0.1IU/mL are usually protective, and titres of >0.1IU/mL are associated
with more certain and prolonged protection.7 Complete immunisation induces
protective levels of antitoxin lasting throughout childhood, but, by middle age,
at least 50% of persons not vaccinated since childhood have levels <0.1IU/
mL.8-10 This has been confirmed in Australia by a national serosurvey.11 Single
low doses of toxoid in previously immunised adults induce protective levels
within 6 weeks.12
Formulations for children aged <10 years

Infanrix hexa GlaxoSmithKline (DTPa-hepB-IPV-Hib; diphtheriatetanus-acellular pertussis-hepatitis B-inactivated poliovirusHaemophilus influenzae type b). The vaccine consists of both a 0.5mL
pre-filled syringe containing 30IU diphtheria toxoid, 40IU tetanus
toxoid, 25g pertussis toxoid (PT), 25g filamentous haemagglutinin
(FHA), 8g pertactin (PRN), 10g recombinant HBsAg, 40 D-antigen
units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units
type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett), adsorbed
onto aluminium hydroxide/phosphate; traces of formaldehyde,
polysorbate 80, polysorbate 20, polymyxin and neomycin; and a
vial containing a lyophilised pellet of 10g purified Hib capsular
polysaccharide (PRP) conjugated to 2040g tetanus toxoid. May
contain yeast proteins.
4.2 DIPHTHERIA
Diphtheria toxoid is available in Australia only in combination with tetanus and

other antigens.
Infanrix IPV GlaxoSmithKline (DTPa-IPV; diphtheria-tetanusacellular pertussis-inactivated poliovirus). Each 0.5mL pre-filled
syringe contains 30IU diphtheria toxoid, 40IU tetanus toxoid,
25g PT, 25g FHA, 8g PRN, 40 D-antigen units inactivated
poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1)
and 32 D-antigen units type 3 (Saukett), adsorbed onto aluminium
hydroxide; traces of formaldehyde, polysorbate 80, polymyxin and
neomycin.
Pediacel Sanofi Pasteur Pty Ltd (DTPa-IPV-Hib; diphtheria-tetanusacellular pertussis-inactivated poliovirus-Haemophilus influenzae type
b). Each 0.5mL monodose vial contains 30IU diphtheria toxoid,
40IU tetanus toxoid, 20g PT, 20g FHA, 3g PRN, 5g pertussis
fimbriae (FIM) 2+3, 40 D-antigen units inactivated poliovirus type
1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen
units type 3 (Saukett), 10g Hib capsular polysaccharide conjugated
to 20g tetanus protein; 1.5mg aluminium phosphate; 50ng
bovine serum albumin; phenoxyethanol as preservative; traces of
formaldehyde, glutaraldehyde, polysorbate 80, polymyxin, neomycin
and streptomycin.
Quadracel Sanofi Pasteur Pty Ltd (DTPa-IPV; diphtheria-tetanusacellular pertussis-inactivated poliovirus). Each 0.5mL monodose vial
contains 30IU diphtheria toxoid, 40IU tetanus toxoid, 20g PT,
20g FHA, 3g PRN, 5g FIM 2+3, 40 D-antigen units inactivated
poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and
32 D-antigen units type 3 (Saukett); 1.5mg aluminium phosphate;
50ng bovine serum albumin; phenoxyethanol as preservative; traces
of formaldehyde, glutaraldehyde, polysorbate 80, polymyxin and
neomycin.
Tripacel Sanofi Pasteur Pty Ltd (DTPa; diphtheria-tetanus-acellular
pertussis). Each 0.5mL monodose vial contains 30IU diphtheria
toxoid, 40IU tetanus toxoid, 10g PT, 5g FHA, 3g PRN, 5g
FIM 2+3; 1.5mg aluminium phosphate; 3.4mg phenoxyethanol.
Reduced antigen formulations for adults, adolescents and

children aged 10 years
ADT Booster CSL Limited/Statens Serum Institut (dT; diphtheriatetanus). Each 0.5mL monodose vial or pre-filled syringe contains
2IU diphtheria toxoid and 20IU tetanus toxoid, adsorbed onto
0.5mg aluminium as aluminium hydroxide.
Adacel Polio Sanofi Pasteur Pty Ltd (dTpa-IPV; diphtheria-tetanusacellular pertussis-inactivated poliovirus). Each 0.5mL monodose vial
or pre-filled syringe contains 2IU diphtheria toxoid, 20IU tetanus
toxoid, 2.5g PT, 5g FHA, 3g PRN, 5g FIM 2+3, 40 D-antigen
units inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type
2 (MEF-1) and 32 D-antigen units type 3 (Saukett); 0.33mg aluminium
as aluminium phosphate; phenoxyethanol as preservative; traces of
and streptomycin.
Boostrix GlaxoSmithKline (dTpa; diphtheria-tetanus-acellular
pertussis). Each 0.5 mL monodose vial or pre-filled syringe contains
2IU diphtheria toxoid, 20IU tetanus toxoid, 8g PT, 8g
FHA, 2.5g PRN, adsorbed onto 0.5mg aluminium as aluminium
hydroxide/phosphate; traces of formaldehyde, polysorbate 80 and
glycine.
Boostrix-IPV GlaxoSmithKline (dTpa-IPV; diphtheria-tetanusacellular pertussis-inactivated poliovirus). Each 0.5mL pre-filled
syringe contains 2IU diphtheria toxoid, 20IU tetanus toxoid, 8g
PT, 8g FHA, 2.5g PRN, 40 D-antigen units inactivated poliovirus
type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and 32 D-antigen
units type 3 (Saukett), adsorbed onto 0.5mg aluminium as aluminium
hydroxide/phosphate; traces of formaldehyde, polysorbate 80,
polymyxin and neomycin.

Infanrix hexa must be reconstituted by adding the entire contents of the syringe
to the vial and shaking until the pellet is completely dissolved. Reconstituted
vaccine should be used as soon as practicable. If storage is necessary, hold at
room temperature for not more than 8 hours.
4.2 DIPHTHERIA
Adacel Sanofi Pasteur Pty Ltd (dTpa; diphtheria-tetanus-acellular

toxoid, 20IU tetanus toxoid, 2.5g PT, 5g FHA, 3g PRN,
5g FIM 2+3; 0.33mg aluminium as aluminium phosphate;
phenoxyethanol as preservative; traces of formaldehyde and
glutaraldehyde.

The dose of all diphtheria-containing vaccines is 0.5mL, to be given by
IM injection.
Do not mix DTPa- or dTpa-containing vaccines or dT vaccine with any other
vaccine in the same syringe, unless specifically registered for use in this way.
Infants and children
Diphtheria toxoid is given in combination with tetanus toxoid and acellular
pertussis as DTPa vaccine. The recommended 3-dose primary schedule is at 2,
4 and 6 months of age. The 1st dose can be given as early as 6 weeks of age, due
to the high morbidity and occasional mortality associated with pertussis in very
young infants. If the 1st dose is given at 6 weeks of age, the next scheduled doses
should still be given at 4 months and 6 months of age (see 4.12 Pertussis).
A booster dose of diphtheria-containing vaccine, usually provided as DTPaIPV, is recommended at 4 years of age, but can be given as early as 3.5 years.
For this booster dose, all brands of DTPa-containing vaccines are considered
interchangeable.
Where required, DTPa-containing vaccines can be given for catch-up for either
the primary doses or booster dose in children aged <10 years (see 2.1.5 Catch-up).
Older children and adolescents

A 2nd booster dose is recommended for adolescents between 10 and 17 years of
age, using the reduced antigen content dTpa. The optimal age for administering
this dose is 1113 years, due to waning immunity (particularly the pertussis
antibody responses) following the 1st booster dose recommended at 4 years
of age. (See also 4.12 Pertussis.) This 2nd booster dose of diphtheria-containing
vaccine is essential for maintaining immunity to diphtheria (and tetanus and
pertussis) into adulthood.
It is recommended to use the reduced antigen content dTpa for booster doses.
However, when necessary, dT can also be used for the booster dose or, if
necessary, for the primary dT course, in persons aged 10 years (see 4.2.12
Variations from product information below).
For details on the management of children and adolescents who require catch-up
vaccination for diphtheria, see 2.1.5 Catch-up.
Adults
Booster vaccination
All adults who reach the age of 50 years without having received a booster
dose of dT in the previous 10 years should receive a further diphtheria booster
dose. This should be given as dTpa, to also provide protection against pertussis
(see 4.12 Pertussis). This stimulates further production of circulating diphtheria
For persons undertaking high-risk travel, consider giving a booster dose of either
dTpa or dT (as appropriate) if more than 5 years have elapsed since the last dose
of a dT-containing vaccine.
Primary vaccination
Persons who have not received any diphtheria vaccines are also likely to
have missed tetanus vaccination. Therefore, 3 doses of dT should be given at
minimum intervals of 4 weeks, followed by booster doses at 10 and 20 years after
the primary course. One of these 3 doses (preferably the 1st) should be given as
dTpa, to also provide additional protection against pertussis. In the event that
dT vaccine is not available, dTpa can be used for all primary doses. However,
this is not recommended routinely because there are no data on the safety,
immunogenicity or efficacy of dTpa in multiple doses for primary vaccination.
For additional information on adults with no history of a primary course of dT
vaccine requiring catch-up, see 2.1.5 Catch-up.

Although dT or dTpa vaccines are not routinely recommended for pregnant
women, they can be given under certain circumstances, such as for management
of a tetanus-prone wound (see 4.19 Tetanus) or to prevent pertussis in pregnant
women and their newborns (see 4.12 Pertussis).14
dT or dTpa vaccines can be given to breastfeeding women.
The only absolute contraindications to diphtheria-containing vaccines are:
anaphylaxis following a previous dose of any diphtheria-containing vaccine

Mild discomfort or pain at the injection site persisting for up to a few days is
common. Uncommon general adverse events following dT vaccine include
headache, lethargy, malaise, myalgia and fever. Anaphylaxis, urticaria and
peripheral neuropathy occur very rarely. Brachial neuritis (inflammation of a
4.2 DIPHTHERIA
antibodies at an age when waning of diphtheria and tetanus immunity is

commencing in the Australian population.11 Diphtheria can be a significant risk
for travellers to some countries (particularly Southeast Asia, New Guinea, the
states of the former Soviet Union, Baltic countries or eastern European countries).
Travellers to countries where health services are difficult to access should be
adequately protected against diphtheria before departure. They should receive a
booster dose of dT (or dTpa if not given previously) if more than 10 years have
elapsed since the last dose of dT-containing vaccine.
nerve in the arm, causing weakness or numbness) has been described following
the administration of tetanus toxoid-containing vaccines, with an estimated
excess risk of approximately 0.51 in 100 000 doses in adults.15,16 For specific
adverse events following combination vaccines containing both diphtheria and
pertussis antigens, see 4.12 Pertussis.
4.2.11 Public health management of diphtheria

Diphtheria is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of diphtheria,
including management of cases of diphtheria and their contacts, should
be obtained from state/territory public health authorities (see Appendix 1
Confirmed or suspected diphtheria is of considerable public health importance
and should be notified immediately to state/territory public health authorities.
In general, contacts of a proven or presumptive diphtheria case will require
vaccination (either primary or booster, depending on vaccination status), and
appropriate prophylactic antibiotics17 (see 4.12 Pertussis).
Advice should be sought with respect to diphtheria antitoxin access and
dosage, and special arrangements made if hypersensitivity is suspected; this
can be coordinated through the relevant state/territory health authority (see
authorities and communicable disease control and Part 5 Passive immunisation).

The product information for Infanrix hexa states that this vaccine is indicated
for primary immunisation of infants from the age of 6 weeks. The ATAGI
recommends that this vaccine may also be used for catch-up of the primary
schedule in children <10 years of age.
The product information for Infanrix IPV states that this vaccine is indicated
for use in a 3-dose primary schedule for immunisation of infants from the
age of 6 weeks and as a single booster dose for children 6 years of age who
have previously been vaccinated against diphtheria, tetanus, pertussis and
poliomyelitis. In addition, the ATAGI recommends that this product may
also be used for catch-up of the primary schedule or as a booster in children
<10 years of age.
The product information for Quadracel states that this vaccine is indicated for
use in a 3-dose primary schedule from the age of 2 months to 12 months and
may also be used as a booster dose for children from 15 months to 6 years of age
who have previously been vaccinated against diphtheria, tetanus, pertussis and
poliomyelitis. The ATAGI recommends that, when appropriate, this product may
also be used for either catch-up of the primary schedule or as a booster dose in
children aged <10 years. The ATAGI also recommends that the primary schedule
may be commenced at 6 weeks of age, if required.
The product information for Pediacel states that this vaccine is indicated for
primary immunisation of infants from the age of 6 weeks and may also be used
as a booster dose for children from 15 to 20 months of age who have previously
been vaccinated against diphtheria, tetanus, pertussis, poliomyelitis and
Haemophilus influenzae type b. The ATAGI recommends that, when appropriate,
this product may also be used for either catch-up of the primary schedule or as a
booster dose in children aged <10 years.
The product information for ADT Booster states that this vaccine is indicated
for use as a booster dose only in children aged 5 years and adults who have
previously received at least 3 doses of diphtheria and tetanus vaccines. The
ATAGI recommends instead that, where a dT vaccine is required, ADT Booster
can be used, including for primary immunisation against diphtheria and tetanus
(for any person 10 years of age).
The product information for Adacel and Boostrix (reduced antigen content
dTpa) states that these vaccines are indicated for booster doses only. The ATAGI
recommends instead that, when a 3-dose primary course of diphtheria/tetanus
toxoids is given to an adolescent/adult, dTpa should replace the 1st dose of dT,
with 2 subsequent doses of dT. If dT is not available, dTpa can be used for all 3
primary doses, but this is not routinely recommended.
The product information for Adacel and Boostrix states that there is no
recommendation regarding the timing and frequency of booster doses against
pertussis in adults; however, the ATAGI recommends that pregnant or postpartum women can receive a booster dose every 5 years and that other adults in
contact with infants and/or at increased risk from pertussis can receive a booster
dose every 10 years.
The product information for Boostrix, Boostrix-IPV and Adacel states that
dTpa-containing vaccine should not be given within 5 years of a tetanus
toxoid-containing vaccine. The product information for Adacel Polio states that
dTpa-containing vaccine should not be given within 3 years of a tetanus toxoidcontaining vaccine. The ATAGI recommends instead that, if protection against
pertussis is required, dTpa-containing vaccines can be administered at any time
following receipt of a dT-containing vaccine.
4.2 DIPHTHERIA
The product information for Tripacel states that this vaccine is indicated for use
in a 3-dose primary schedule from the age of 2 months to 12 months and may
also be used as a booster dose for children from 15 months to 8 years of age who
have previously been vaccinated against diphtheria, tetanus and pertussis. The
ATAGI recommends that, when appropriate, this product may also be used for
either catch-up of the primary schedule or as a booster dose in children aged
<10 years. The ATAGI also recommends that the primary schedule may be
commenced at 6 weeks of age, if required.
The product information for Boostrix, Boostrix-IPV, Infanrix hexa and

Infanrix IPV states that these vaccines are contraindicated in children with
encephalopathy of unknown aetiology or with neurologic complications
occurring within 7 days following a vaccine dose. The ATAGI recommends
instead that the only contraindication is a history of anaphylaxis to a previous
dose or to any of the vaccine components.
References
4.3 HAEMOPHILUS INFLUENZAE TYPE B

Haemophilus influenzae is a Gram-negative coccobacillus that is a normal part
of upper respiratory tract flora. It can be isolated in two forms: capsular and
non-capsular. Strains isolated from respiratory tract specimens, such as sputum
and middle ear or sinus fluid, usually do not have a capsule, and are known
as non-typeable Haemophilus influenzae (NTHi). Six capsular types (a to f) have
been described and, before the introduction of vaccination against Haemophilus
influenzae type b (Hib), almost all H.influenzae isolates from sterile sites (blood,
cerebrospinal fluid, joint or pleural fluid) were of the b capsular type.1
Before Hib immunisation, invasive disease caused by Hib rarely occurred
after the age of 5 years. This was because the prevalence of antibody to Hib
progressively increased from the age of 2 years, thought to be related to exposure
to Hib (or cross-reacting organisms) colonising the nasopharynx or other sites.
Children <2 years of age are usually unable to mount an antibody response to the
type b capsular polysaccharide, even after invasive disease.2

Clinical categories of invasive disease caused by Hib include meningitis,
epiglottitis and a range of other infections such as septic arthritis, cellulitis and
pneumonia.3 Hib is rarely isolated from the blood without a focal infection such
as the above being evident or developing subsequently. The classical clinical
signs of meningitis neck stiffness and photophobia are often not detected in
infants, who present with drowsiness, poor feeding and high fever. Epiglottitis
(inflammation of the epiglottis) presents with respiratory obstruction, associated
with soft stridor and often drooling in a pale, febrile, anxious child who remains
upright to maximise his or her airway. Meningitis and epiglottitis are almost
invariably fatal without appropriate treatment. The case-fatality rate for Hib
meningitis in developed countries is at least 3% even with treatment, and 15 to
30% of survivors have permanent neurological sequelae.1 There are no specific
clinical features of any of the focal infections due to Hib that enable them
to be differentiated from those due to other organisms. However, before the
introduction of Hib vaccines, epiglottitis was due to Hib in over 95% of cases.4
Non-typeable Haemophilus influenzae strains may occasionally cause invasive
disease, but are a common cause of otitis media in children and bronchitis in
adults.2 Hib vaccines are not effective in preventing NTHi infections.
4.3.3 Epidemiology
Since Hib vaccines were included in the routine vaccination schedule in 1993,
there has been a reduction of more than 95% in notified cases of Hib disease.
In 1992 alone, 549 Hib cases were reported; in contrast, during the 2 years
from January 2006 to December 2007, a total of 39 Hib infections were notified
in Australia, giving an average annual notification rate of 0.09 per 100 000
4.3 HAEMOPHILUS
INFLUENZAE TYPE B
4.3.1 Bacteriology
population.5-7 The reduction in the incidence of Hib disease following routine

vaccination has been particularly marked in Indigenous children, although
absolute rates remain substantially higher than those in the non-Indigenous
population.8-10 Similar impressive reductions in Hib disease have been seen in
other countries with routine childhood vaccination.11,12 Since Hib disease has
become relatively rare, cases of epiglottitis can no longer be assumed to be due
to H.influenzae type b and, moreover, even when H.influenzae is isolated from
a normally sterile site, it may not be type b. Thus, laboratory confirmation of
H.influenzae infection and serotype should always be sought before vaccination
failure is assumed.13,14
4.3.4 Vaccines
Four types of conjugate Hib vaccines have been developed, each containing the
Hib capsular polysaccharide polyribosylribitol phosphate (PRP) conjugated to a
different carrier protein. Of these, PRP-OMP (conjugated to the outer membrane
protein of Neisseria meningitidis), PRP-T (conjugated to tetanus toxoid) and
HbOC (conjugated to a mutant diphtheria toxoid) elicit antibody responses
associated with protection of children against Hib. The fourth vaccine type,
PRP-D (conjugated to diphtheria toxoid), was less immunogenic and found to be
poorly protective in high-risk populations, such as Indigenous children.15 PRP-T
has subsequently been included in a number of combination vaccines, including
DTPa-hepB-IPV-Hib and Hib-MenCCV.
In Australia, the differing epidemiology of invasive Hib disease by ethnicity
and region has determined the recommendations for Hib vaccine choice (see 3.1
Vaccination for Aboriginal and Torres Strait Islander people). There have been four
distinct eras of implementation of the Hib vaccination program for Australian
children, which are described in detail elsewhere.10
Some Hib combination vaccines containing acellular pertussis are known to
produce lower Hib antibody responses than similar formulations containing
whole-cell pertussis.16 When administered according to the United Kingdoms
schedule as 3 primary doses at 2, 3 and 4 months of age without a booster, their
use has been associated with an increased risk of vaccine failure.17 In other
European countries that routinely give a 4th dose around the time of the 1st
birthday, as Australia does, no loss of effectiveness has been observed.18,19
Monovalent Hib vaccines

Act-HIB Sanofi Pasteur Pty Ltd (PRP-T). Lyophilised powder
in a monodose vial with a pre-filled diluent syringe. Each 0.5mL
reconstituted dose contains 10g Hib capsular polysaccharide
(polyribosyl-ribitol-phosphate [PRP]) conjugated to 1830g
tetanus protein.
Liquid PedvaxHIB CSL Limited/Merck & Co Inc (PRP-OMP). Each

0.5mL monodose vial contains 7.5g Hib capsular polysaccharide
(PRP) conjugated to 125g Neisseria meningitidis outer membrane
protein (OMP) complex; 225g aluminium as aluminium hydroxide;
35g borax.
Combination vaccines that contain Hib

Infanrix hexa GlaxoSmithKline (DTPa-hepB-IPV-Hib; diphtheriatetanus-acellular pertussis-hepatitis B-inactivated poliovirusHaemophilus influenzae type b [PRP-T]). The vaccine consists of both
a 0.5mL pre-filled syringe containing 30IU diphtheria toxoid,
40IU tetanus toxoid, 25g pertussis toxoid (PT), 25g filamentous
haemagglutinin (FHA), 8g pertactin (PRN), 10g recombinant
HBsAg, 40 D-antigen units inactivated poliovirus type 1 (Mahoney),
8 D-antigen units type 2 (MEF-1) and 32 D-antigen units type 3
(Saukett), adsorbed onto aluminium hydroxide/phosphate; traces
of formaldehyde, polysorbate 80, polysorbate 20, polymyxin and
neomycin; and a vial containing a lyophilised pellet of 10g purified
Hib capsular polysaccharide (PRP) conjugated to 2040g tetanus
toxoid. May contain yeast proteins.
Menitorix GlaxoSmithKline (Hib-MenCCV; Haemophilus influenzae
type b [PRP-T]-meningococcal serogroup Ctetanus toxoid conjugate).
Lyophilised powder in a monodose vial with a pre-filled diluent
syringe. Each 0.5mL reconstituted dose contains 5g Hib capsular
polysaccharide (PRP) conjugated to 12.5g tetanus toxoid, and 5g
Neisseria meningitidis serogroup C polysaccharide conjugated to 5g
tetanus toxoid; traces of trometamol and sucrose.
b [PRP-T]). Each 0.5mL monodose vial contains 30IU diphtheria
pertussis fimbriae (FIM) 2+3, 40 D-antigen units inactivated poliovirus
type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1) and
32 D-antigen units type 3 (Saukett), 10g Hib capsular polysaccharide
(PRP) conjugated to 20g tetanus protein; 1.5mg aluminium
phosphate; 50ng bovine serum albumin; phenoxyethanol as
preservative; traces of formaldehyde, glutaraldehyde, polysorbate 80,
polymyxin, neomycin and streptomycin.
4.3 HAEMOPHILUS
INFLUENZAE TYPE B
Hiberix GlaxoSmithKline (PRP-T). Lyophilised pellet in a monodose

vial with separate diluent. Each 0.5mL reconstituted dose contains
10g Hib capsular polysaccharide (PRP) conjugated to 30g tetanus
toxoid; lactose.

Act-HIB must be reconstituted by adding the entire contents of the diluent syringe
to the vial and shaking until the powder is completely dissolved. Reconstituted
vaccine must be used immediately.
Hiberix must be reconstituted by adding the entire contents of the diluent container
+2C to +8C for not more than 24 hours.
Menitorix must be reconstituted by adding the entire contents of the diluent
syringe to the vial and shaking until the powder is completely dissolved.
Reconstituted vaccine should be used as soon as practicable. If storage is
necessary, hold at +2C to +8C for not more than 24 hours.

The dose of all Hib-containing vaccines is 0.5mL to be given by IM injection.

All Hib-containing vaccines may be administered in separate sites on the same
day as any of the other childhood vaccines such as pneumococcal conjugate,
meningococcal serogroup C conjugate (MenCCV), hepatitis B, DTPa-containing
and inactivated poliomyelitis vaccine (IPV) (or IPV-containing) vaccines.
No or minimal immunologic interference has been observed when children are
vaccinated with pneumococcal conjugate vaccines (7vPCV Prevenar; 13vPCV
Prevenar 13; or 10vPCV Synflorix) and PRP-T-containing hexavalent vaccine
(Infanrix hexa) at the same immunisation visit.21-24
Interchangeability of Hib vaccines

Where possible, the same brand of Hib-containing vaccine should be used for
all primary doses. If different Hib-containing vaccines (i.e. PRP-OMP and PRP-T
vaccines) are used in the primary series, then 3 doses (of any Hib-containing
vaccine) are required at 2, 4 and 6 months of age, with a booster of a Hibcontaining vaccine at 12 months of age. For booster doses and in children
>15 months of age, regardless of previous Hib vaccinations, a single dose of any
Hib-containing vaccine is sufficient for protection.
Infants
The 1st dose of a Hib-containing vaccine can be given as early as 6 weeks of age.
If the 1st dose is given at 6 weeks of age, the next scheduled doses should still be
given at 4 months and 6 months of age.
Booster doses
A single booster dose of Hib vaccine is recommended at 12 months of age
(see Infants above). This booster dose can be administered using either the
monovalent Hib vaccine or, where meningococcal serogroup C vaccination is
also scheduled, the combined Hib-meningococcal serogroup C conjugate vaccine
(Hib-MenCCV).
Children aged >15 months and up to 59 months of age at presentation who
have not received a primary course of a Hib or Hib-containing vaccine will only
require 1 dose of vaccine as catch-up, irrespective of the number of previous
doses administered. There should be a minimum 2-month interval between their
last dose and the catch-up dose. Catch-up for Hib vaccination for children up to
59 months of age is outlined in Table 2.1.8 Catch-up schedule for Hib vaccination for
children <5 years of age in 2.1.5 Catch-up.
Preterm infants
Preterm infants can be immunised according to their chronological age, without
correction for prematurity (see 3.3.2 Vaccination of women who are planning
pregnancy, pregnant or breastfeeding, and preterm infants). For PRP-T-containing Hib
vaccines, including Infanrix hexa, no change in the usual schedule is required.
Preterm infants have been shown to produce good antibody responses to all the
antigens in Infanrix hexa following administration at 2, 4 and 6 months of age,
although the responses to hepatitis B and Hib are not quite as high as in full-term
infants.25
If a PRP-OMP-containing Hib vaccine is used for the primary doses in an
extremely preterm and/or low-birth-weight baby (<28 weeks gestation or
<1500g birth weight), an additional dose should be given at 6 months of age; that
is, doses should be given at 2, 4, 6 and 12 months of age.
Persons with functional or anatomical asplenia

Hib is an uncommon cause of post-splenectomy sepsis in adults and children.
A single dose of Hib vaccine is recommended for persons with functional
or anatomical asplenia who were not fully vaccinated in early childhood
4.3 HAEMOPHILUS
INFLUENZAE TYPE B
A Hib-containing vaccine is recommended for all infants from 2 months of age.

PRP-T-containing Hib vaccines require 3 primary doses, at 2, 4 and 6 months of
age, followed by a booster dose at 12 months of age. Immunisation using PRPOMP-containing Hib vaccine only requires 2 primary doses, at ages 2 and
4 months, followed by a booster at 12 months of age.
according to the recommendations above and Table 2.1.8 Catch-up schedule for
Hib vaccination for children <5 years of age. If vaccination is required, the dose
should, where possible, be given 2 weeks before a planned splenectomy or
at approximately 1 week following an emergency splenectomy. Subsequent
booster doses of Hib vaccine are not required.26 For all recommendations
for persons with functional or anatomical asplenia, see 3.3.3 Vaccination of
immunocompromised persons, Table 3.3.5 Recommendations for vaccination in persons
with functional or anatomical asplenia.
Allogeneic and autologous haematopoietic stem cell transplant recipients

Allogeneic and autologous haematopoietic stem cell transplant (HSCT) recipients
should also be given Hib vaccine post transplant. Three doses of Hib conjugate
vaccine should be administered to HSCT recipients at 6, 8 and 12 months
after transplant. See 3.3.3 Vaccination of immunocompromised persons, Table 3.3.3
Recommendations for revaccination following HSCT in children and adults, irrespective
of previous immunisation history.

Hib vaccine is not routinely recommended for pregnant or breastfeeding women.
However, for women who have functional or anatomical asplenia refer to
Persons with functional or anatomical asplenia above.
The only absolute contraindications to Hib-containing vaccines are:
anaphylaxis following a previous dose of any Hib-containing vaccine

Swelling and redness at the injection site after the 1st dose are common and have
been reported in up to 5% of vaccinated children. Fever in up to 2% has also been
reported. These adverse events usually appear within 3 to 4 hours of vaccination
and resolve completely within 24 hours. The incidence of these adverse events
declines with subsequent doses, so it is recommended that the course of
vaccination be completed regardless.
4.3.11 Public health management of invasive Hib disease
Further instructions about the public health management of Hib, including

management of cases of invasive Hib disease and their contacts, should

The product information for Infanrix hexa states that these vaccines are
contraindicated in children with encephalopathy of unknown aetiology or with
neurologic complications occurring within 7 days following a vaccine dose.
The ATAGI recommends instead that the only contraindication is a history of
anaphylaxis to a previous dose or to any of the vaccine components.
The product information for Act-HIB, Hiberix and Liquid PedvaxHIB states that
these vaccines are indicated for use in children aged 2 months to 5 years. The
ATAGI also recommends administration of Hib vaccine to older people with
asplenia or following either allogeneic or autologous haematopoietic stem cell
transplantation.
References
4.3 HAEMOPHILUS
INFLUENZAE TYPE B
Haemophilus influenzae type b is a notifiable disease in all states and territories

in Australia.
4.4 HEPATITIS A
4.4.1 Virology
Hepatitis A is an acute infection of the liver caused by the hepatitis A virus
(HAV), a picornavirus (a small single-stranded RNA virus).1 The virus survives
well in the environment outside of the human host. It persists on hands for
several hours and in food kept at room temperature for considerably longer, and
is relatively resistant to heat and freezing.

Hepatitis A is an infection of humans; there is no animal reservoir.1 HAV is
predominantly transmitted by the faecaloral route. The infecting dose is
unknown, but it is presumed to be low. The incubation period of hepatitis A is 15
to 50 days, with a mean of about 28 days.2 HAV is excreted in faeces for up to 2
weeks before the onset of illness and for at least 1 week afterwards.1
In young children, HAV usually causes either an asymptomatic infection or a
very mild illness without jaundice; adults are more likely to have symptomatic
infection (over 70%).2 Patients with symptomatic illness typically have a 4- to
10-day prodrome of systemic (fever, malaise, weakness and anorexia) and
gastrointestinal (nausea and vomiting) symptoms. Dark urine is usually the first
specific manifestation of acute hepatitis A infection, followed a day or two later
by jaundice and pale faeces.2 The prodromal symptoms tend to wane with the
onset of jaundice, although the anorexia and malaise may persist; pruritus and
localised hepatic discomfort or pain may follow.1 The duration of illness varies,
but most patients feel better and have normal, or near normal, liver function
tests within a month of the onset of illness.3 Complications of hepatitis A are
uncommon but include, on rare occasions, fulminant hepatitis.4 The case-fatality
rate of hepatitis A increases with age.2 Hepatitis A does not cause chronic liver
disease. Relapse has been found in up to 10% of cases, but recovery is universal.
HAV does not cause chronic infection and immunity after infection is life-long.2
Diagnosis of hepatitis A is made by detecting anti-HAV IgM in serum during the
acute illness. Anti-HAV IgM is invariably present by the time the patient presents
and persists for 3 to 6 months after the acute illness.1 Serum anti-HAV IgG alone
indicates past infection (or possibly immunisation) and therefore immunity; it
probably persists for life.1
4.4.3 Epidemiology
Hepatitis A was a considerable public health problem in Australia in the 1990s.
During this time, numerous outbreaks occurred in child day-care centres and
preschools,5 Indigenous communities,6 communities of men who have sex with
men,7 schools and residential facilities for the disabled,8 and communities of
persons who inject drugs.7 A very large outbreak of hepatitis A, associated with
the consumption of raw oysters, occurred in New South Wales in 1997 and there
was a large outbreak associated with semidried tomatoes during 2009.9,10
4.4.4 Vaccines
Monovalent hepatitis A vaccines
Avaxim Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis
A virus [GBM strain]). Each 0.5mL pre-filled syringe contains 160
antigen units of hepatitis A virus (HAV) antigens inactivated by
formaldehyde; 0.3mg aluminium as aluminium hydroxide; 2.5L
phenoxyethanol; 12.5g formaldehyde; traces of neomycin and
bovine serum albumin.
Havrix Junior GlaxoSmithKline (formaldehyde-inactivated
hepatitis A virus [HM175 strain]). Each 0.5mL monodose vial or
pre-filled syringe contains 720 ELISA units of HAV antigens; 0.25mg
aluminium as aluminium hydroxide; traces of formaldehyde,
neomycin and polysorbate 20.
Havrix 1440 GlaxoSmithKline (formaldehyde-inactivated
hepatitis A virus [HM175 strain]). Each 1.0mL monodose vial or
pre-filled syringe contains 1440 ELISA units of HAV antigens; 0.5
mg aluminium as aluminium hydroxide; traces of formaldehyde,
neomycin and polysorbate 20.
4.4 HEPATITIS A
In recent years, hepatitis A notifications and hospitalisations have been low with
a downward trend.11 This has been accompanied by an increasing proportion of
cases related to travel to countries where hepatitis A is endemic.12-14 Advocacy
for hepatitis A vaccination of travellers and those at increased risk because of
lifestyle or occupation remains a priority, as does the hepatitis A vaccination
program for Aboriginal and Torres Strait Islander children. Established
initially in north Queensland in 1999 for Indigenous children aged 18 months,6
the hepatitis A vaccination program was expanded in 2005 to include all
Indigenous children aged 2 years in the Northern Territory, Queensland, South
Australia and Western Australia, contributing substantially to the decline in
notifications.15,16 In north Queensland, most Indigenous children >2 years of
age have now been immunised against hepatitis A. However, it is important to
note that Indigenous children remain at considerably greater risk not only of
acquiring hepatitis A, but also for being hospitalised with the infection than
non-Indigenous children.11,17 This is particularly true for Indigenous children
residing in other regions of Queensland, the Northern Territory, South Australia
and Western Australia. (See also 3.1 Vaccination for Aboriginal and Torres Strait
Islander people.)
Vaqta Paediatric/Adolescent formulation CSL Limited/Merck & Co

Inc (formaldehyde-inactivated hepatitis A virus [CR326F strain]). Each
0.5mL monodose vial or pre-filled syringe contains approximately
25units (U) of hepatitis A virus protein; 0.225mg aluminium as
aluminium hydroxide; 35g borax; traces of formaldehyde, neomycin
and bovine serum albumin.
Vaqta Adult formulation CSL Limited/Merck & Co Inc
(formaldehyde-inactivated hepatitis A virus [CR326F strain]). Each
1.0mL monodose vial or pre-filled syringe contains approximately
50U of hepatitis A virus protein; 0.45mg aluminium as aluminium
hydroxide; 70g borax; traces of formaldehyde, neomycin and bovine
serum albumin.
Combination vaccines that contain hepatitis A

Twinrix Junior (360/10) GlaxoSmithKline (formaldehyde-inactivated
hepatitis A virus [HM175 strain] and recombinant hepatitis B vaccine).
Each 0.5mL monodose vial or pre-filled syringe contains 360 ELISA
units of HAV antigens, 10g recombinant DNA hepatitis B surface
antigen protein; 0.225mg aluminium as aluminium phosphate/
hydroxide; traces of formaldehyde, neomycin, trometamol and
polysorbate 20. May contain yeast proteins.
Twinrix (720/20) GlaxoSmithKline (formaldehyde-inactivated
Vivaxim Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis A
virus [GBM strain] and typhoid Vi capsular polysaccharide). Supplied
in a dual-chamber syringe which enables the two vaccines to be mixed
just before administration. Each 1.0mL dose of mixed vaccine contains
160 ELISA units of inactivated hepatitis A virus antigens, 25g purified
typhoid Vi capsular polysaccharide strain Ty2; 0.3mg aluminium as
aluminium hydroxide; 2.5L phenoxyethanol; 12.5g formaldehyde;
traces of neomycin, bovine serum albumin and polysorbate 80.
Inactivated hepatitis A vaccines induce HAV antibodies (anti-HAV) at titres

many-fold greater than are provided by the recommended dose of normal
human immunoglobulin. Although the vaccines are highly immunogenic (see
below), antibody titres are usually below the detection limits of the routinely
available commercial tests for anti-HAV.1 Therefore, serological testing to assess
immunity after vaccination against hepatitis A is neither necessary nor appropriate.
Likewise, it is also inappropriate to undertake testing if an individual cannot
recall if he/she has been vaccinated against hepatitis A in the past; if no
vaccination records are available, vaccination should be advised. However,
certain groups of people should be screened for natural immunity to hepatitis A
to avoid unnecessary vaccination: those born before 1950; those who spent their
early childhood in endemic areas; and those with an unexplained previous
episode of hepatitis or jaundice. In addition, it is necessary to test for other causes
of hepatitis, in particular hepatitis B, in those with unexplained jaundice.
Hepatitis A vaccines are highly immunogenic in both children and adults,
with virtually universal seroconversion 4 weeks after vaccination.1,18,19 Two
randomised clinical trials conducted in the early 1990s showed that the
vaccines have a very high protective efficacy, approaching 100%.20,21 This
finding is supported by the apparent eradication of hepatitis A from Indigenous
communities in north Queensland and the Northern Territory since the
introduction of the vaccination program in those regions.6,16
The duration of immunity, and therefore protection, following vaccination is
not certain. However, vaccine-induced anti-HAV probably persists for many
years. There is no current evidence that booster doses are required; in healthy
individuals, it is quite possible that they will never be required.22

Transport according to National vaccine storage guidelines: Strive for 5.23
Store at +2C to +8C. Do not freeze.

Inactivated hepatitis A vaccines are to be given by IM injection.
The recommended doses and schedules are shown in Table 4.4.1.
4.4 HEPATITIS A
Inactivated hepatitis A vaccines are prepared from HAV harvested from

human diploid cell cultures, which are then purified by ultrafiltration and
chromatography, inactivated by formaldehyde, and adsorbed onto aluminium
hydroxide adjuvant. Although the vaccines are prepared from differing strains of
HAV, there is only one known serotype; immunity induced by a particular strain
probably provides protection against all strains.1
Avaxim
160 ELISA U
0.5
1st dose: day 0 (day of vaccination)

2nd dose: 6 to 12 months after 1st dose
Havrix
Junior
2<16
720 ELISA U
0.5

Havrix
1440
16
1440 ELISA U
1.0

1<18
25 U
0.5

18
50 U
1.0

Dose
(HAV
antigen)
Number
of doses
Vaccination
schedule
Volume
per dose
(mL)
Vaccine
Age of
vaccine
recipient
(years)
Table 4.4.1: R
ecommended doses and schedules for use of inactivated hepatitis
A and hepatitis A combination vaccines*
Monovalent hepatitis A vaccines
Vaqta
Paediatric/
Adolescent
Vaqta
Adult
Combination hepatitis A/hepatitis B vaccines

Twinrix
Junior
(360/10)
1<16
360 ELISA U
0.5

2nd dose: 1 month after 1st dose
3rd dose: 6 months after 1st dose
Twinrix
(720/20)
1<16
720 ELISA U
1.0

Twinrix
(720/20)
16
720 ELISA U
1.0

Twinrix
(720/20)
16
720 ELISA U
1.0

2nd dose: 7 days after 1st dose
3rd dose: 21 days after 1st dose
4th dose: 12 months after 1st dose
Note: This accelerated schedule is not
suitable for all circumstances.
1.0
1st dose: single dose of Vivaxim (mixed

vaccine) on day 0 (day of vaccination)
Combination hepatitis A/typhoid vaccine

Vivaxim
16
160 ELISA U
(+ 1
monovalent
hepatitis
A vaccine)
2nd dose: for long-term protection

against hepatitis A, a 2nd dose
of hepatitis A-containing vaccine
(monovalent hepatitis A vaccine)
should be given between 6 and 36
months after the dose of Vivaxim
* For more information on combination hepatitis A/hepatitis B vaccines and schedules, see also
4.5 Hepatitis B.
This schedule should not be used for persons who require prompt protection against hepatitis B,
for example, if there is close contact with a person known to be chronically infected with
hepatitis B.
This accelerated schedule should be used only if there is very limited time before departure to
either moderately or highly endemic regions (see also 4.5 Hepatitis B, Accelerated schedules).
Combination hepatitis A/hepatitis B vaccines can be administered

simultaneously with, or at any time before or after, all other vaccines relevant
to international travel.
The combination hepatitis A/typhoid vaccine can be administered
to international travel.
Interchangeability of hepatitis A vaccines

Although the manufacturers use slightly different production methods and
quantify the HAV antigen content in their respective vaccines differently, the
hepatitis A vaccines of the different manufacturers used in equivalent schedules
in Table 4.4.1 can be considered interchangeable, when given in a 2-dose course.
As there is only one brand of combination hepatitis A/hepatitis B vaccine,
interchangeability is not relevant. (See also Recommendations for the use of
combination hepatitis A/hepatitis B vaccines in 4.4.7 Recommendations below.)
Hepatitis A vaccination is recommended for persons with an increased risk
of acquiring hepatitis A and/or who are at increased risk of severe disease.
Serological testing for immunity to hepatitis A from previous infection is
not usually required prior to vaccination, but may be indicated in some
circumstances (see Serological testing for hepatitis A immunity from infection
and/or vaccination below).
When vaccination against both hepatitis A and hepatitis B (or hepatitis A and
typhoid) is indicated, combination vaccines may be used, as described below.
Recommendations for hepatitis A vaccine

Hepatitis A vaccination is recommended for the following groups:
Aboriginal and Torres Strait Islander children residing in the Northern Territory, Queensland,
South Australia and Western Australia
Two doses of hepatitis A vaccine are required for Aboriginal and Torres Strait
Islander children living in these jurisdictions, due to the increased risk for
hepatitis A in this population (see 4.4.3 Epidemiology above). Vaccination for
these children should commence in the 2nd year of life, with the 1st dose given
between 12 and 18 months of age, and the 2nd dose given between 18 and 24
months of age. The recommended interval between doses is 6 months (see
Table 4.4.1). State/territory health authorities should be contacted about local
hepatitis A vaccination schedules, including catch-up.
4.4 HEPATITIS A
Hepatitis A vaccines are inactivated vaccines and can be administered either

to international travel.24
Travellers (1 year of age) to hepatitis A endemic areas
Travellers to (1 year of age), and expatriates living in, moderately to highly

endemic areas for hepatitis A should receive hepatitis A vaccine.25 A single dose
of a monovalent hepatitis A vaccine provides protective levels of anti-HAV for at
least a year;1 a 2nd dose is recommended 6 to 12 months following the 1st dose,
to increase the duration of protection (see Table 4.4.1).
Persons whose occupation puts them at increased risk of acquiring hepatitis A
Persons whose occupation puts them at increased risk of acquiring hepatitis A

include: persons who live or work in rural and remote Indigenous communities
and/or persons who regularly provide care for Aboriginal and Torres Strait
Islander children in the Northern Territory, Queensland, South Australia and
Western Australia; staff working in early childhood education and care; carers
of persons with developmental disabilities; and plumbers or sewage workers.
See also 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended
vaccinations for persons at increased risk of certain occupationally acquired vaccinepreventable diseases.
Persons whose lifestyle puts them at increased risk of acquiring hepatitis A
Persons who engage in anal intercourse, men who have sex with men, persons
who inject drugs (including inmates of correctional facilities) and sex industry
workers are at increased risk of acquiring hepatitis A.26 See also 3.3 Groups with
special vaccination requirements.
Persons with developmental disabilities
Vaccination is recommended for persons with developmental disabilities, and

susceptible carers, who attend both residential and non-residential facilities for
persons with developmental disabilities. Although conditions/measures to limit
the likelihood of hepatitis A transmission in such facilities have improved in
recent decades, outbreaks of hepatitis A can occur in these settings.26
Persons with chronic liver disease, liver solid organ transplant recipients and/or those chronically
infected with either hepatitis B or hepatitis C viruses
Hepatitis A vaccination is recommended for persons with chronic liver disease

of any aetiology.2,26 Those with chronic liver disease of mild to moderate severity
mount a satisfactory immune response following vaccination, but those with
end-stage liver disease do not respond as well, and liver transplant recipients
may not respond at all.27,28 Nevertheless, all those with chronic liver disease who
are non-immune to hepatitis A should be vaccinated, preferably as early in the
course of the disease as possible.
Vaccination is recommended for persons with chronic hepatitis C and hepatitis B
infection because of the high case-fatality rate among these persons if they
acquire hepatitis A.2
Recommendations for the use of combination hepatitis A/hepatitis B vaccines
Persons in whom combination hepatitis A/hepatitis B vaccines may be suitable

for use include:
travellers to, and expatriates living in, moderately to highly endemic areas
(for hepatitis A and B)

The combination hepatitis A/hepatitis B vaccine is recommended in a 3-dose

schedule, administered prior to travel. Twinrix (720/20) can be administered
according to a rapid schedule if there is limited time before departure.29 This
consists of a single dose on each of days 0, 7 and 21, followed by a 4th dose
12 months after the 1st dose. It is important that a 4th dose be given to ensure
longer-term protection (see Table 4.4.1).
persons whose lifestyle puts them at increased risk of hepatitis A and

hepatitis B (sexually active men who have sex with men, sex industry
workers, persons who inject drugs and inmates of correctional facilities)
persons who attend or work at residential or non-residential facilities for
people with developmental disabilities
persons with occupational risks of exposure to both hepatitis A and hepatitis B
persons with chronic liver disease and/or hepatitis C
solid organ transplant liver recipients or solid organ transplant recipients
who have chronic liver disease (see Table 3.3.2 Recommendations for
vaccinations for solid organ transplant (SOT) recipients).
See Recommendations for hepatitis A vaccine above and 4.5 Hepatitis B for more
details. See also 3.3 Groups with special vaccination requirements.
Recommendations for the use of combination hepatitis A/typhoid vaccine

The combination hepatitis A/typhoid vaccine (see Table 4.4.1) is recommended
as an option for all persons 16 years of age who intend travelling to developing
countries where there is an increased risk of acquiring hepatitis A and typhoid
4.4 HEPATITIS A
Combination hepatitis A/hepatitis B vaccines should be considered for

susceptible persons in whom both hepatitis A and hepatitis B vaccines are
recommended. Vaccination is usually provided in a 3-dose schedule (see Table
4.4.1). Twinrix (720/20) can be administered in a 2-dose regimen in persons 1 to
<16 years of age (see Table 4.4.1); however, this regimen should not be used in
those who require prompt protection against hepatitis B, for example, if there is
close contact with a person known to be chronically infected with hepatitis B.
If a combination hepatitis A/hepatitis B vaccine is not available, monovalent
hepatitis A and hepatitis B vaccines can be administered simultaneously (in
separate syringes at separate sites) (see Interchangeability of hepatitis A
vaccines above). The use of schedules mixing combination hepatitis A/
hepatitis B vaccines with the respective monovalent vaccines is not routinely
recommended.
fever. This combination is particularly useful for those already immunised

against hepatitis B.
To provide longer-term protection against hepatitis A, a single dose of a
monovalent adult formulation hepatitis A vaccine administered between 6 and
36 months after the single dose of combination hepatitis A/typhoid vaccine
is required (see Table 4.4.1). If there is a continued risk of typhoid infection, a
booster dose of parenteral typhoid Vi polysaccharide vaccine is required
3 years after the single dose of combination hepatitis A/typhoid vaccine. The
combination hepatitis A/typhoid vaccine may be used as a booster vaccine
for hepatitis A if a person received a previous dose of a monovalent adult
formulation hepatitis A vaccine; this should be given at a minimum interval of
6 months after the 1st dose of hepatitis A vaccine.
Serological testing for hepatitis A immunity from infection and/or vaccination

Serological testing for immunity to hepatitis A is not recommended before
routine administration of hepatitis A vaccine to those in most of the categories
above, for example, Aboriginal and Torres Strait Islander children or travellers.
However, previous infection with hepatitis A is more likely to have occurred in
persons born before 1950, those who spent their early childhood in an endemic
area, and those with an unexplained previous episode of hepatitis or jaundice.
In such persons, testing for total hepatitis A antibodies or anti-HAV IgG may be
indicated, and, if positive, indicates immunity to hepatitis A. Such persons do not
need hepatitis A vaccination.
Serological testing following vaccination is not routinely required.

Hepatitis A vaccine is not routinely recommended for pregnant or breastfeeding
women, but can be given where vaccination is considered necessary (see 4.4.7
Recommendations above).
The only absolute contraindications to hepatitis A vaccines are:
anaphylaxis following a previous dose of any hepatitis A vaccine
Combination vaccines containing the hepatitis B component are contraindicated
in persons with a history of anaphylaxis to yeast.
Hepatitis A vaccines do not affect liver enzyme levels. They can be safely given
to persons with HIV infection, and do not adversely affect either the HIV load or
CD4+ cell count.30
4.4.11 Public health management of hepatitis A

Hepatitis A is a notifiable disease in all states and territories in Australia. Detailed
information regarding the management of hepatitis A cases and contacts can be
found in the national guidelines for control of hepatitis A31 (www.health.gov.au/
cdnasongs).
Further instructions can also be obtained from state/territory public health
authorities (see Appendix 1 Contact details for Australian, state and territory
Post-exposure prophylaxis using hepatitis A vaccine or normal human
immunoglobulin (NHIG) can be used to prevent secondary cases in close
contacts of hepatitis A cases. However, vaccination is recommended in preference
to NHIG for use in post-exposure prophylaxis in persons 12 months of age who
are immunocompetent (see Part 5 Passive immunisation).31

None.
References
4.4 HEPATITIS A
The most common adverse events following administration of hepatitis A

vaccines are mild local events of a short duration, probably caused by the
aluminium hydroxide adjuvant. About 15% of adults report headache and
approximately 5% report malaise or fatigue following vaccination.26 Up to 20% of
children who receive either Havrix or Vaqta experience soreness at the injection
site. In both adults and children, systemic adverse events such as headache and
fever are much less common than local adverse events.26
4.5 HEPATITIS B
4.5.1 Virology
Hepatitis B virus (HBV) contains circular, partially double-stranded DNA. The
outer surface of the virus is glycolipid, which contains the hepatitis B surface
antigen (HBsAg). Other important antigenic components are the hepatitis B core
antigen (HBcAg) and hepatitis B e antigen (HBeAg). HBcAg is not detectable
in serum, but can be detected in liver tissue in persons with acute or chronic
hepatitis B infection. HBeAg, and antibodies against HBeAg (anti-HBe) or the
HBcAg (anti-HBc), are serological markers of HBV infection. Antibodies against
HBsAg (anti-HBs) indicate immunity, which may result from either natural
infection or immunisation (in which case there would not be any markers of HBV
infection). Persistence of HBsAg denotes infectivity, which is greater if HBeAg
and/or HBV DNA are also positive.1 Occult hepatitis B infection is characterised
by the presence of HBV DNA in the liver (with or without detectable HBV DNA
in the serum) and negative HBsAg.2

In approximately 30 to 50% of adults, infection causes symptomatic acute
hepatitis, but in neonates and young children, particularly those <1 year of age,
initial infection is usually asymptomatic.3,4 The incubation period is usually 45 to
180 days and the period of communicability extends from several weeks before
the onset of acute illness usually to the end of the period of acute illness. Acute
illness is clinically indistinguishable from other forms of hepatitis, and symptoms
include fever, jaundice, malaise, anorexia, nausea and vomiting, abdominal
pain (especially in the right upper quadrant), myalgia, and the passage of darkcoloured urine and light-coloured stools. Jaundice may be preceded by an acute
febrile illness with arthralgia or arthritis and rash, most typical of hepatitis B.
During recovery, malaise and fatigue may persist for many weeks. Fulminant
hepatitis occurs in up to 1% of acute cases.1,5
Following acute infection, approximately 1 to 10% of persons infected in
adulthood,4,6 but up to 90% of those infected in early infancy,6 become chronically
infected with hepatitis B. Persons chronically infected with HBV are identified
by the long-term presence (longer than 6 months) of circulating HBsAg.1,5
Those with occult infection may reactivate HBV infection if they become
immunocompromised.
Persons with chronic HBV infection are capable of transmitting the disease,
including mother-to-child peripartum transmission, though they often remain
asymptomatic and may not be aware that they are infected. Most of the serious
complications associated with hepatitis B occur in the context of chronic HBV
infection, which is associated in up to 25% of cases with premature mortality due
to cirrhosis and/or hepatocellular carcinoma.1
4.5.3 Epidemiology
Chronic infection and its sequelae, including cirrhosis and hepatocellular

carcinoma, contribute to the majority of HBV disease burden in Australia. In
recent decades, the burden from such disease has been increasing, concurrent
with the increasing number of immigrants from regions of high HBV
prevalence.11 Aboriginal and Torres Strait Islander people, and migrants born
in Asia and Pacific islands, North Africa, Middle Eastern and Mediterranean
countries, have a significantly increased prevalence of chronic HBV infection
compared with the rest of the Australian-born population.12,13 First-generation
immigrants of culturally and linguistically diverse background, who are
mostly from countries of high HBV endemicity, usually retain the prevalence
of chronic HBV infection of their country of origin. Other population groups
with an increased prevalence of markers of HBV infection include patients with
HIV infection, persons who used injected drugs between 1980 and 1990, and
household contacts of someone diagnosed with hepatitis between 1980 and
1990.13 Notification of chronic HBV infection depends on levels of hepatitis B
testing and reporting, and a substantial proportion of persons with chronic HBV
infection remain undiagnosed. It has been estimated by mathematical modelling
that, in 2010, about 170 000 people were living with HBV infection in Australia,
with about 335 deaths due to HBV infection in that year.14
Newly acquired cases of HBV infection in Australia mostly occur in young
adults, through injecting drug use, skin penetration procedures or sexual
contact.15 Between 2006 and 2010, the notification rate of newly acquired
hepatitis B in Australia ranged from 1.0 to 1.4 per 100 000 population.
Since 2001, the rate of diagnosis of newly acquired infections has declined
substantially among people aged 1529 years and has remained relatively stable
among people aged 30 years.14-16 However, some new HBV infections are
asymptomatic and may go undetected.
Similar to chronic infection, higher rates of notified cases of newly acquired
hepatitis B, or hospitalisation due to acute hepatitis B, have been reported
among Aboriginal and Torres Strait Islander people compared with the general
Australian population.17,18 In one United States study, adults with diabetes
mellitus had a greater chance of developing acute hepatitis B disease than
4.5 HEPATITIS B
The prevalence of chronic HBV infection differs in different parts of the world,
and may be quite variable within countries. The prevalence of chronic HBV
infection varies from less than 0.5% among Caucasians in the United States,
northern Europe and Australia, 1 to 5% in the Mediterranean countries, parts
of eastern Europe, Africa, Central and South America, up to greater than 10%
in many sub-Saharan African, East and Southeast Asian and Pacific island
populations.7-10 In regions of moderate to high prevalence of HBsAg (where 2%
of the population is HBsAg-positive), infections are mainly acquired perinatally
or in early childhood.1
the general population;19 however, there are no published Australian studies

examining this.
Transmission of HBV may result from inoculation through broken or penetrated
skin, or by mucosal contact with blood or other body fluids (mainly vaginal
fluids and semen) from an infectious person. There are four major routes of
HBV transmission:
perinatal transmission from infected mother to neonate (vertical
transmission), usually occurring at or around the time of birth
parenteral or mucosal exposure to infected blood and other bodily fluids;
common scenarios include:
sharing of contaminated equipment that penetrates the skin, such as
needles (among persons who inject drugs), tattoo equipment, bodypiercing equipment, acupuncture equipment and razor blades
needle-stick injury, for example, in a healthcare setting
contact between infective body fluids and mucous membranes
sexual contact (including vaginal or anal intercourse, although the latter is
associated with a higher risk)
non-sexual contact with an infected person (horizontal transmission),
including household transmission, for example, child-to-child transmission
through contact between open sores or wounds.
In Australia, screening of blood and organ donors using nucleic acid
amplification testing has virtually eliminated the risk of transmission of
hepatitis B through blood transfusion and organ transplants.20,21 Saliva may
contain levels of virus that are likely to be infective only if inoculated directly
into tissue (ocular or mucous membranes). The risk of transmission by
inadvertent inoculation by other means, such as by toothbrush, razor etc., or
through close personal contact in households in which one or more infected
persons reside, is low but not negligible.22-29
The strategy for prevention of hepatitis B through immunisation in Australia
commenced in the early 1980s, with vaccination programs targeting individuals
with increased risk of HBV exposure, including infants at particular
risk of infection at birth. Universal infant vaccination commenced in the
Northern Territory in 1990. A universal hepatitis B vaccination program was
recommended for infants and adolescents in 1996. The adolescent program
commenced in some states and territories in 1997 and the universal infant
program, which includes a dose given at birth, began nationally in 2000. The
adolescent program will continue until those immunised for hepatitis B in the
infant program reach adolescence.
4.5.4 Vaccines
Engerix-B GlaxoSmithKline (recombinant DNA hepatitis B vaccine).

Adult formulation Each 1.0mL monodose vial or pre-filled syringe
contains 20g recombinant hepatitis B surface antigen (HBsAg)
protein, adsorbed onto 0.5mg aluminium as aluminium hydroxide.
Paediatric formulation Each 0.5mL monodose vial or pre-filled
syringe contains 10g HBsAg protein, adsorbed onto 0.25mg
aluminium as aluminium hydroxide.
Both formulations may contain yeast proteins.
H-B-Vax II CSL Limited/Merck & Co Inc (recombinant DNA
hepatitis B vaccine). Adult formulation Each 1.0mL monodose
vial or pre-filled syringe contains 10g recombinant HBsAg protein,
adsorbed onto 0.5mg aluminium hydroxide. Paediatric formulation
Each 0.5mL monodose vial or pre-filled syringe contains 5g
recombinant HBsAg protein, adsorbed onto 0.25mg aluminium
hydroxide. Dialysis formulation Each 1.0mL monodose vial
contains 40g recombinant HBsAg protein, adsorbed onto 0.5mg
aluminium hydroxide.
All formulations may contain yeast proteins.
Combination vaccines that contain hepatitis B

toxoid, 25g pertussis toxoid, 25g filamentous haemagglutinin,
8g pertactin, 10g recombinant HBsAg, 40 D-antigen units
inactivated poliovirus type 1 (Mahoney), 8 D-antigen units type
2 (MEF-1) and 32 D-antigen units type 3 (Saukett), adsorbed
Twinrix Junior (360/10) GlaxoSmithKline (formaldehyde-inactivated
4.5 HEPATITIS B
Monovalent hepatitis B vaccines

Twinrix (720/20) GlaxoSmithKline (formaldehyde-inactivated
Hepatitis B vaccines are prepared using recombinant technology. After

purification, the HBsAg protein is adsorbed onto elemental aluminium (as
hydroxide and/or phosphate). Hepatitis B vaccines may contain up to 1% yeast
proteins (but no yeast DNA).
The Engerix-B and the H-B-Vax II vaccines are manufactured by different
processes, and the HBsAg content of an equivalent dose of these 2 vaccines is
different. Studies of hepatitis B vaccines have been conducted using different
schedules and intervals for different age groups. Acceptable schedules are shown
in Table 4.5.1 and are described below.
The standard 3-dose schedule and variations

Neonates, children and young adults aged <20 years
The Australian infant schedule consists of a dose of monovalent hepatitis B

vaccine given at birth, followed by 3 doses of a hepatitis B-containing
combination vaccine, given at 2, 4 and 6 months of age (see Infants and young
children in 4.5.7 Recommendations below). If an infant did not receive the
birth dose within the 1st 7 days of life, catch-up of that dose is not necessary.
Such infants then only require 3 doses of a hepatitis B-containing combination
vaccine, given at 2, 4 and 6 months of age. For infants, the final dose of the
primary course should not be administered before reaching 24 weeks of age.30
This schedule (of birth dose, followed by hepatitis B-containing vaccine at 2,
4, and 6 months of age) has been shown to be equally immunogenic when
compared with giving monovalent hepatitis B vaccine in a 3-dose schedule at
birth, 12 months and 618 months of age; this hepatitis B vaccine schedule is
often used overseas.31-33 Children born overseas who have received hepatitis B
vaccine in this 3-dose schedule can also be considered to have completed the
primary vaccination course.
Adults aged 20 years
For adults, monovalent hepatitis B vaccine adult formulation (1.0mL) is given

in a 3-dose schedule at times 0, 1 and 6 months (see Table 4.5.1). There is some
flexibility regarding the interval between the doses. The proportion of vaccine
recipients attaining a seroprotective anti-HBs antibody level (10mIU/mL),
generally measured at 12 months post vaccination, is comparable between
adults who received their 3rd dose at 46 months after the 1st dose and those
who received their 3rd dose 6 months or more after the 1st.36 Increasing the
interval between the 1st and 2nd doses has little effect on the final antibody
level attained, but a longer interval between the 2nd and 3rd doses is associated
with a higher final antibody level.37-39 However, for those who may be exposed
to hepatitis B, delaying the 3rd dose may increase the risk of acquiring HBV
infection. No published studies support an interval of less than 4 months
between the 1st and the 3rd doses in a 3-dose schedule.
Thus, for a shortened 3-dose schedule to attain comparable antibody levels
to the standard 3-dose schedule, all three of the following minimum interval
requirements must be satisfied:
the minimum interval between the 1st and 2nd doses is 1 month,
the minimum interval between the 2nd and 3rd doses is 2 months, and
the minimum interval between the 1st and 3rd doses is 4 months (or 16 weeks).
That is, either a 0, 1, 4 month or a 0, 2, 4 month interval schedule is an acceptable
3-dose schedule for adults.40
Note that the interval between the 1st and 3rd doses has been shortened to
less than 4 months in studies of 4-dose accelerated schedules, with the aim to
achieve a higher seroprotective antibody level sooner. However, as antibody
levels are substantially lower after 3 accelerated doses than after the standard
3-dose schedule,39 a 4th dose is required (see Accelerated schedules below and
Table 4.5.1).
The standard 3-dose schedule induces protective levels of neutralising
antibody against hepatitis B virus in more than 90% of adults. The frequency
4.5 HEPATITIS B
For older children and young adults aged <20 years (who have not received
hepatitis B vaccination earlier in life) a 3-dose schedule of the paediatric
formulation (0.5mL) of monovalent hepatitis B vaccine can be used (at times 0,
1 and 6 months), as per Table 4.5.1. Immunogenicity studies suggest there can be
some flexibility of the vaccination schedule intervals for monovalent hepatitis B
vaccines. The use of longer time intervals between doses does not impair the
immunogenicity of hepatitis B vaccine, especially in adolescents and young
children.34,35 For children, aged 1 year, the minimum interval between the 1st
and 3rd doses of a 3-dose primary schedule is 4 months. A shortened 3-dose
schedule provided at either 0, 1, 4 months or 0, 2, 4 months is acceptable for
children and adolescents aged <20 years.30 (See also 2.1.5 Catch-up.)
of seroconversion increases progressively from approximately 35% after the 1st

dose to more than 90% after the 3rd dose. There is evidence of immunity in most
vaccine recipients after administration of 2 doses of a 3-dose schedule. However,
the 3rd dose is necessary to increase the percentage of responders and to provide
long-term protection.
Alternative 2-dose schedule for adolescents

Several studies have demonstrated that adolescents 1115 years of age who
receive 2 doses of adult formulation monovalent hepatitis B vaccine 4 to
6 months apart develop similar protective antibody levels to those vaccinated
using paediatric formulations in the standard 3-dose schedule.41-43
Using a 2-dose schedule for the 1115 years age group may improve
compliance and will provide comparable immunogenicity to that of a 3-dose
paediatric schedule. Adolescents (1115 years of age) can be vaccinated with
the adult formulation of either H-B-Vax II or Engerix-B in a 2-dose schedule
(see Table 4.5.1).
Table 4.5.1: R
ecommended schedules for use of monovalent hepatitis B and
hepatitis B combination vaccines
Volume per
dose (mL)
Number of
doses
Recommended schedule
intervals*
10 g
(Engerix-B)
or
5 g
(H-B-Vax II)
0.5
Birth (if not given at birth, may

be given up to 7 days of age)
10 g
0.5
1st dose: 2 months of age

2nd dose: 4 months of age
(2 months after 1st dose)
3rd dose: 6 months of age
(2 months after 2nd dose)
Dose
(HBsAg
protein)
Age of
vaccine
recipient
Vaccine
Recommended infant schedule

Engerix-B (paediatric
formulation)
or
H-B-Vax II (paediatric
formulation)
birth
Combination hepatitis
B-containing vaccine 2, 4 and 6
months
(e.g. Infanrix hexa
DTPa-hepB-IPV-Hib)
Monovalent hepatitis B vaccines standard 3-dose schedule

Engerix-B (paediatric
formulation)
<20 years
10 g
0.5
1st dose: day 0 (day of

vaccination)
Engerix-B (adult
formulation)
20 years
20 g
1.0

vaccination)
H-B-Vax II (paediatric
formulation)
<20 years
5 g
0.5

vaccination)
Number of
doses
Volume per
dose (mL)
Dose
(HBsAg
protein)
intervals*
Monovalent hepatitis B vaccines standard 3-dose schedule

H-B-Vax II (adult
formulation)
20 years
10 g
1.0

vaccination)
H-B-Vax II (dialysis
formulation)
20 years
40 g
1.0

vaccination)
Monovalent hepatitis B vaccines 2-dose schedule ONLY for adolescents aged 1115 years
Engerix-B (adult
formulation)
1115
years
20 g
1.0

vaccination)
2nd dose: 6 months after 1st
dose
H-B-Vax II (adult
formulation)
1115
years
10 g
1.0

vaccination)
2nd dose: between 4 and 6
months after 1st dose
Combination hepatitis A/hepatitis B vaccines

Twinrix (720/20)
1<16
years
20 g
1.0

vaccination)
2nd dose: between 6 and 12
months after 1st dose (2-dose
schedule)
Twinrix Junior
(360/10)
1<16
years
10 g
0.5

vaccination)
16 years
20 g
1.0

vaccination)
Twinrix (720/20)
* For minimum intervals, see text above.

In these schedules, the day 0 dose refers to the day when the 1st dose is given (i.e. day 0 of the
vaccination course), not the age of the recipient. For infant vaccination, where the 1st dose is a
birth dose it is indicated as so.
The final dose of the primary course should not be administered before reaching 24 weeks of age.
This schedule should not be used for those who require prompt protection against hepatitis B, for
example, if there is close contact with a person known to be chronically infected with hepatitis B.
Accelerated schedules
Engerix-B (monovalent hepatitis B vaccine, paediatric and adult) and Twinrix
(720/20) (combination hepatitis A/hepatitis B vaccine) are also registered for
use in accelerated schedules, which consist of 4 doses in total (see Table 4.5.2).
Accelerated schedules result in a high proportion of adolescents and adults
attaining a seroprotective anti-HBs antibody level (10mIU/mL) in the early
4.5 HEPATITIS B
Age of
vaccine
recipient
Vaccine
months following commencement of the schedule. However, multiple studies

have consistently shown that antibody levels are substantially lower at month 7,
after 3 accelerated doses, than after the standard 3-dose schedule (0, 1, 6 months).39
Also, some studies, in particular among persons who inject drugs and/or inmates
of correctional facilities, have shown a lower proportion of subjects attaining the
seroprotective antibody level after 3 doses of an accelerated schedule than after
the standard 3-dose schedule.39,44,45 After the 4th dose of an accelerated schedule,
administered at 12 months, anti-HBs antibody levels are higher or comparable
to those after a standard 3-dose schedule. Hence, it is important for long-term
protection that a 4th dose be administered at 12 months to complete an
accelerated schedule.
Accelerated schedules should only be used for those persons with an imminent
risk of exposure, such as those intending to travel to hepatitis B endemic areas
with a very limited time before departure. As higher seroprotective rates after the
3rd dose of an accelerated 4-dose schedule are seen after the 0, 1, 2, 12 months
schedule than after the 0, 7, 21 days, 12 months schedule, it is recommended that
the latter schedule only be used in exceptional circumstances.
Engerix-B
(paediatric
formulation)
Number
of doses
Volume
(mL)
Dose
(HBsAg
protein)
Vaccine
Age of
vaccine
recipient
(years)
Table 4.5.2: A
ccelerated hepatitis B vaccination schedules (for persons with
imminent risk of exposure)
minimum interval

<20
10 g
0.5

Engerix-B
(adult
formulation)
20
20 g
1.0

or
Twinrix
(720/20)
16
20 g
1.0

Combination hepatitis A/hepatitis B vaccine schedules
The use of mixed vaccine schedules using both the combination hepatitis A/
hepatitis B vaccine and monovalent hepatitis B vaccines is not routinely
recommended. Generally, use of the same brand of vaccine is recommended. (See
also Interchangeability of hepatitis B vaccines in 4.5.6 Dosage and administration
below.)

+2C to +8C. Do not freeze.

The schedules for hepatitis B vaccines and for combination hepatitis A/
hepatitis B vaccines are shown in Table 4.5.1. For combination hepatitis A/
hepatitis B vaccines, see also 4.4 Hepatitis A.
The dose of Engerix-B and H-B-Vax II (paediatric formulations) and Twinrix
Junior (360/10) is 0.5mL, to be given by IM injection.
The dose of Engerix-B and H-B-Vax II (adult formulations) and Twinrix (720/20)
is 1.0mL, to be given by IM injection.
The dose of Infanrix hexa is 0.5mL, to be given by IM injection.
Hepatitis B and combination hepatitis A/hepatitis B vaccines can generally be
co-administered simultaneously with, or at any time before or after, all other
vaccines.
Interchangeability of hepatitis B vaccines

The Engerix-B and H-B-Vax II vaccines are manufactured by different processes,
and the HBsAg content of an equivalent dose is different. Although switching
of vaccine brands is not recommended, in cases where the brand of vaccine used
for previous doses is not known, another age-appropriate equivalent dose
brand (see Table 4.5.1) may be used. For example, a study in healthy neonates
demonstrated comparable high levels of immunogenicity between two different
4.5 HEPATITIS B
The schedules for combination hepatitis A/hepatitis B vaccines are shown in

Table 4.5.1 (and 4.4 Hepatitis A). Three-dose schedules for adults and children
aged <16 years are acceptable; however, a 2-dose schedule in children 115 years
of age, using Twinrix (720/20), also results in protective antibody levels for both
hepatitis A and hepatitis B. An accelerated schedule for combination hepatitis A/
hepatitis B vaccine in those aged 16 years is shown in Table 4.5.2. The
appropriate use of accelerated schedules is discussed above.
mixed regimens that used two monovalent hepatitis B vaccines from different
manufacturers.47 As there is only one brand of combination hepatitis A/
hepatitis B vaccine, interchangeability is not relevant. (See also Combination
hepatitis A/hepatitis B vaccine schedules in 4.5.4 Vaccines above.)
Infants and young children
The recommended hepatitis B vaccine schedule for infants from birth is shown in
Table 4.5.1. A birth dose of monovalent paediatric formulation hepatitis B vaccine
is recommended for all newborn infants. Following this birth dose, 3 doses of a
hepatitis-B-containing combination vaccine (usually provided as DTPa-hepBIPV-Hib) are recommended for all children, at 2, 4 and 6 months of age. Thus, a
total of 4 doses of hepatitis B vaccine are provided in the 1st year of life. The 1st
dose of a hepatitis B-containing combination vaccine can be given as early as
6 weeks of age. If the 1st dose is given at 6 weeks of age, the next scheduled
doses should still be given at 4 months and 6 months of age.
If an infant has not received a birth dose within the 1st 7 days of life, a primary
3-dose course of a hepatitis B-containing combination vaccine should be given, at
2, 4 and 6 months of age; catch-up of the birth dose is not necessary. Irrespective
of whether a birth dose was given, the infant should not be given the final dose
before 24 weeks of age.
The rationale for recommending the birth dose for all newborn infants is not only
to prevent vertical transmission from a mother with chronic hepatitis B infection
(recognising that there may be errors or delays in maternal testing, reporting,
communication or appropriate response), but also to prevent horizontal
transmission to the infant in the first months of life from persons with chronic
hepatitis B infection who are household or other close contacts.48 The birth dose
should be given as soon as the baby is medically stable, and preferably within
24 hours of birth. Every effort should be made to administer the vaccine before
discharge from the obstetric hospital or delivery unit. All newborns of mothers
known to have chronic hepatitis B infection must be given a birth dose of
hepatitis B vaccine and hepatitis B immunoglobulin (HBIG) (see Management of
infants born to mothers who are HBsAg-positive below).
Although it is not routinely recommended in Australia, infants or toddlers
who have received a 3-dose schedule of monovalent vaccine (often given
overseas) with doses at birth, 12 months of age and 6 months of age can also
be considered fully vaccinated. The important consideration is that there should
have been an interval of at least 2 months between the 2nd and 3rd doses, and
that the final dose should not be administered before 24 weeks of age (see also
4.5.4 Vaccines above).
Management of infants born to mothers who are HBsAg-positive
Infants born to HBsAg-positive mothers should be given HBIG and a dose of

monovalent hepatitis B vaccine on the day of birth, concurrently but in separate
thighs. The dose of HBIG is 100IU, to be given by IM injection. It is preferable to
administer HBIG immediately after birth (preferably within 12 hours of birth and
certainly within 48 hours) as its efficacy decreases markedly if given more than
48 hours after birth.
The dose of monovalent hepatitis B vaccine should be given to the infant
preferably within 24 hours of birth, and definitely within 7 days. This regimen
results in seroconversion rates of more than 90% in neonates, even with
concurrent administration of HBIG. Vaccination should not be delayed beyond
7 days after birth, as vaccination alone has been shown to be reasonably effective
in preventing infection, provided it is given early.52 Three subsequent doses of
a hepatitis B-containing vaccine should be given, at 2, 4 and 6 months of age, so
that the infant receives a total of 4 doses of hepatitis B-containing vaccines.
Anti-HBs antibody and HBsAg levels should be measured in infants born to
mothers with chronic hepatitis B infection 3 to 12 months after completing
the primary vaccine course. Testing should not be performed before 9 months
of age to avoid detection of anti-HBs antibodies from HBIG given at birth. If
anti-HBs antibody levels are adequate (10mIU/mL) and HBsAg is negative,
then the infant is considered to be protected30 (see Serological testing following
hepatitis B vaccination below). If the anti-HBs level is <10mIU/mL, then the
possibility of HBV infection should be investigated.51 Expert advice regarding
revaccination and/or further testing should be sought for such children.
Preterm and low-birth-weight infants
Low-birth-weight preterm newborn infants do not respond as well to

hepatitis B-containing vaccines as full-term infants.53-55 Thus, for lowbirth-weight infants (<2000g) and/or infants born at <32 weeks gestation
(irrespective of weight), it is recommended to give the vaccine in a 4-dose
schedule at 0 (birth), 2, 4 and 6 months of age, followed by either:
measuring the anti-HBs antibody level at 7 months of age, and if the antibody
titre is <10mIU/mL, giving a booster at 12 months of age (due to a better
immunogenic response at this age compared with a younger age); or
giving a booster of a hepatitis B-containing vaccine at 12 months of age
(without measuring the antibody titre).
4.5 HEPATITIS B
Routine antenatal screening of pregnant women for HBsAg is recommended

to enable appropriate management to prevent newborn infants developing
HBV infection (see 4.5.2 Clinical features and 4.5.3 Epidemiology above).49-51 It also
enables appropriate follow-up and management of mothers who have chronic
HBV infection, identification of the HBV immune status of other household
members, and protection of those who are susceptible to HBV infection.
HIV-positive and immunocompromised children
All HIV-positive and immunocompromised children should be age-appropriately

vaccinated against hepatitis B.
HIV-positive children should receive 3 doses of hepatitis B vaccine using an
adult formulation (i.e. double the standard recommended dose for children). In a
limited number of studies, paediatric haemodialysis patients have demonstrated
improved response when given higher doses in a 3-dose schedule.56,57
For specific hepatitis B recommendations for immunocompromised children, see
3.3.3 Vaccination of immunocompromised persons.
Adolescents
Vaccination of adolescents 1013 years of age is recommended for all those in
this age group who have not already received a primary course of hepatitis B
vaccine. Refer to your state/territory health authority for further information
about hepatitis B vaccine for this age group (see Appendix 1 Contact details for
Australian, state and territory government health authorities and communicable disease
control).
As the risk in Australian schools is very low,58 vaccination of classroom contacts
of hepatitis B cases is seldom indicated. Nevertheless, vaccination of all children
and adolescents should be encouraged.
A 2-dose schedule of hepatitis B vaccine using the adult formulation of either of
the available monovalent vaccines should be considered for adolescents aged
1115 years who are to receive hepatitis B vaccination (see Table 4.5.1 and 4.5.4
Vaccines above). A 2-dose schedule increases compliance and thus protection in
this age group.
Adolescents who did not receive an age-appropriate completed course of
vaccination should be identified and offered catch-up vaccination, particularly if
they fall into one of the risk categories for hepatitis B infection, discussed under
Adults below.
Adults
Hepatitis B vaccination is recommended for the following groups of adults
because they are either at a higher risk of acquiring hepatitis B infection and/
or at higher risk of severe disease. Serological testing for previous or chronic
hepatitis B infection may be indicated in many circumstances (see Serological
testing prior to hepatitis B vaccination below). See also 3.3 Groups with special
vaccination requirements.
When vaccination against both hepatitis B and hepatitis A is indicated, the
combination hepatitis A/hepatitis B vaccines may be used. See Tables 4.5.1 and
4.5.2 above and Recommendations for the use of combination hepatitis A/
hepatitis B vaccines below.
Household or other close (household-like) contacts of persons with hepatitis B
Sexual contacts of persons with hepatitis B
Susceptible sexual partners of persons with acute hepatitis B should be offered

post-exposure HBIG and hepatitis B vaccination; both should be initiated within
14 days of the last sexual contact (see 4.5.11 Public health management of hepatitis B
below and Table 4.5.3). Susceptible partners of those with chronic HBV infection
should also be offered vaccination.
Hepatitis B is relatively common in clients of sexual health services and
vaccination should be offered to susceptible persons at the time of first
attendance.
Susceptible, sexually active men who have sex with men should be vaccinated.
The combination hepatitis A/hepatitis B vaccine may be appropriate for men
who have sex with men, if they are not immune to either disease, as they are
at increased risk of both conditions (see Recommendations for the use of
combination hepatitis A/hepatitis B vaccines below).
Migrants from hepatitis B endemic countries
Migrants from hepatitis B endemic countries have a higher likelihood of having

been previously infected with hepatitis B and of having a close household contact
with chronic hepatitis B infection. Such persons should be offered testing for
hepatitis B, and vaccination if appropriate. (See also 3.3.8 Vaccination of migrants
to Australia.) Areas of high endemicity, indicated by high seroprevalence of
HBsAg, include most of East and Southeast Asia (except Japan), Pacific island
groups, parts of central Asia and the Middle East, the Amazon Basin, and subSaharan Africa.59
Aboriginal and Torres Strait Islander people
There is an increased risk of acquiring new HBV infection among Aboriginal

and Torres Strait Islander people compared with other Australians.17,18 Although
many younger Aboriginal and Torres Strait Islander people, especially children
and adolescents, would have been eligible for, and have received, hepatitis B
vaccination through population-wide vaccination programs, it is recommended
that Aboriginal and Torres Strait Islander people have their risks and vaccination
status for hepatitis B reviewed, be offered testing for previous hepatitis B
infection, and be offered vaccination if non-immune. (See also 3.1 Vaccination for
Aboriginal and Torres Strait Islander people.)
4.5 HEPATITIS B
There is a low, but definite, risk of transmission from a person with acute or
chronic hepatitis B to household or other close residential contacts (e.g. students
or asylum seekers sharing residential facilities). This can be reduced by avoiding
contact with blood or other body fluids and not sharing items that may penetrate
the skin (such as combs, nail brushes, toothbrushes and razors). Immunisation
of susceptible household-like contacts is strongly recommended. This includes
household members of the adoptive family if the adopted child is known to have
chronic hepatitis B infection.
Adult haemodialysis patients and patients with severely impaired renal function in whom
dialysis is anticipated
Dialysis patients, and patients with severely impaired renal function in whom
dialysis is anticipated, may be at increased risk of acquiring hepatitis B infection
and also respond less well to vaccination. These patients should be given a larger
than usual dose of hepatitis B vaccine.
Adult haemodialysis or pre-dialysis patients should be given either:
1.0mL of Engerix-B adult formulation (20g) in each arm at each schedule
point (i.e. effectively giving a double dose on each occasion) in a 4-dose
schedule at 0, 1, 2 and 6 months;60 or
a single dose of H-B-Vax II dialysis formulation (40g) on each occasion in a
3-dose schedule at 0, 1 and 6 months.
Solid organ and haematopoietic stem cell transplant recipients
If seronegative for hepatitis B, solid organ transplant recipients should be

vaccinated before transplantation as they may be at increased risk of infection
from the transplanted organ.61 Haematopoietic stem cell transplant recipients
should be revaccinated following transplantation, due to the loss of immune
memory that often follows the transplant procedure. (See also 3.3.3 Vaccination of
immunocompromised persons.)
HIV-positive adults and other immunocompromised adults
HIV-positive adults, and other immunocompromised adults, may be at increased

risk of acquiring hepatitis B infection and also respond less well to vaccination.
Limited studies in HIV1-positive adults have demonstrated an improved and
accelerated serological response to a schedule that consists of 4 double doses,
comprising two injections of the standard adult dose (using Engerix-B) on each
occasion, at times 0, 1, 2 and 6 months.62,63
Persons with chronic liver disease and/or hepatitis C
Hepatitis B vaccination is recommended for those in this category who are

seronegative for hepatitis B, because of the risk of severe liver disease following
infection with hepatitis B.64
Persons who inject drugs
Persons who inject drugs should be tested, and be vaccinated if they have not
previously been infected with HBV.
Recipients of certain blood products
Screening of all blood donors for HBV using HBsAg and nucleic acid
amplification tests has greatly decreased the incidence of transfusion-related
hepatitis B virus infection. Since 2010, nucleic acid testing has been introduced
nationally to improve detection of hepatitis B infection in donated blood, mainly
through reduction of the infectious window period when acute hepatitis B
infection may not be detected using HBsAg, but also through detecting persons
Persons with developmental disabilities
Vaccination is recommended for persons who attend either residential or nonresidential day-care facilities for persons with developmental disabilities. This
is due to the high prevalence of markers indicating past or current infection in
persons in these settings, including an HBsAg prevalence of >10%.67-69
Inmates of correctional facilities
Inmates are at increased risk of hepatitis B infection because of the prevalence

of chronic hepatitis B among inmates, and the potential for unprotected sexual
intercourse, injecting drug use and amateur tattooing in correctional facilities.
Therefore, they should be offered the opportunity to be screened for hepatitis B
upon incarceration, as part of the preventive health program for blood-borne
viruses, and vaccinated if susceptible.
Sex industry workers
Sex industry workers are one of the population groups at higher risk of HBV
infection. They have been specifically identified as an important population on
which to focus for the prevention of hepatitis B transmission.70 They are at a
particularly high risk if they engage in unprotected sex.
Persons at occupational risk
The risk to persons in certain occupations differs considerably from setting to

setting in different parts of Australia. However, it is recommended that all staff
directly involved in patient care and/or the handling of human tissue, blood
or body fluids should be vaccinated. In addition, standard precautions against
exposure to human tissue, blood or body fluids should be used as a matter of
routine.71
Other occupations where the risk of acquiring hepatitis B is increased include:
police, members of the armed forces, emergency services staff and staff of
correctional facilities; these persons should be vaccinated if they are assigned
to duties that may involve exposure to human tissue, blood or body fluids
funeral workers, embalmers and other workers who have regular contact
with human tissue, blood or body fluids and/or used needles or syringes
staff involved in both residential and non-residential care of persons with
developmental disabilities, due to the high prevalence of markers of past or
current infection in persons in this setting67-69
workers who perform skin penetration procedures (e.g. tattooists, bodypiercers).
4.5 HEPATITIS B
with occult hepatitis B infection. This further reduces the residual risk of
hepatitis B transmission through transfusion in Australia, from approximately 1
in 739 000 to less than 1 in 1 million.65 However, persons with clotting disorders
who receive blood product concentrates, persons with recurrent transfusion
requirements, and persons with underlying immunocompromise66 have an
elevated risk of hepatitis B virus infection, and should therefore be vaccinated.
Staff of child day-care centres will normally be at minimal risk of hepatitis B. If

advice on risk is sought, the enquiry should be directed to the local public health
authority.
Contact sports generally carry a low risk of hepatitis B infection. However, ageappropriate hepatitis B vaccination is recommended.
Travellers to hepatitis B endemic areas
Persons travelling to regions of intermediate or high endemicity, either long-term

or for frequent short terms, or who are likely to undertake activities that increase
their risks of exposure to HBV during travel, should be vaccinated.59 (See also 3.2
Vaccination for international travel.)
Recommendations for the use of combination hepatitis A/hepatitis B vaccines

Combination hepatitis A/hepatitis B vaccines should be considered for
susceptible persons in whom both hepatitis A and hepatitis B vaccines are
recommended, including:
travellers to, and expatriates living in, moderately to highly endemic areas
for hepatitis A and B
persons whose lifestyle puts them at increased risk of hepatitis A and
hepatitis B (sexually active men who have sex with men, sex industry
workers, persons who inject drugs and inmates of correctional facilities)
persons who attend or work at residential or non-residential facilities for
people with developmental disabilities
persons with occupational risks of exposure to both hepatitis A and hepatitis B
persons with chronic liver disease and/or hepatitis C
solid organ transplant liver recipients or solid organ transplant recipients
who have chronic liver disease (see Table 3.3.2 Recommendations for
vaccinations for solid organ transplant (SOT) recipients).
If a combination hepatitis A/hepatitis B vaccine is not available, monovalent
hepatitis A and hepatitis B vaccines can be administered simultaneously (in
separate syringes at separate sites) (see Interchangeability of hepatitis B
vaccines above).
See 4.5.7 Recommendations above and 4.4 Hepatitis A for more details. See also 3.3
Groups with special vaccination requirements.
Booster doses
Booster doses of hepatitis B vaccine (after completion of a primary course by a
recommended schedule) are not recommended for immunocompetent persons.
This applies to children and adults, including healthcare workers and dentists.72-78
This is because there is good evidence that a completed primary course of
hepatitis B vaccination provides long-lasting protection. Even though vaccineinduced antibody levels may decline with time and may become undetectable,
Serological testing prior to hepatitis B vaccination

Routine antenatal screening of all pregnant women for HBsAg is recommended
to allow appropriate measures to be implemented to prevent newborn infants
developing chronic HBV infection49-51 (see Management of infants born to
mothers who are HBsAg-positive above).
Serological testing for evidence of past (or current) hepatitis B infection prior
to vaccination may be warranted for certain older children, adolescents
and adults. This is particularly so for those at increased risk of acquiring
hepatitis B infection, such as persons who inject drugs, sex industry workers,
immunocompromised persons, and those living in communities with higher
prevalence of HBV, including migrant communities and Aboriginal and Torres
Strait Islander people. Serological testing enables identification of persons who
were infected by HBV, to facilitate timely appropriate clinical management and
prevention of onward transmission, hence reducing population impact of HBV
infection. Testing also identifies those who are susceptible to HBV infection and,
as such, should be offered vaccination if they continue to have a high exposure
risk (see 4.5.7 Recommendations above).70 Testing for immunity to hepatitis A
infection (and vaccination of susceptible at-risk persons with combination
hepatitis A/hepatitis B vaccines) may also be indicated for some population
groups at increased risk of hepatitis A exposure (see 4.4 Hepatitis A).
Serological testing following hepatitis B vaccination

Anti-HBs antibody and HBsAg levels should be measured in infants born to
mothers with chronic hepatitis B infection 3 to 12 months after completing the
primary vaccine course (for more information see Management of infants born
to mothers who are HBsAg-positive above).
Other than for infants born to mothers with chronic hepatitis B infection, postvaccination serological testing is recommended 4 to 8 weeks after completion of
the primary course for persons in the following categories:
those at significant occupational risk (e.g. healthcare workers whose work
involves frequent exposure to human tissue, blood or body fluids)
those at risk of severe or complicated HBV disease (e.g. persons who are
immunocompromised, and persons with pre-existing liver disease not related
to hepatitis B)
4.5 HEPATITIS B
immune memory persists and is thought to result in a protective immune

response on re-exposure.79 However, booster doses are recommended for persons
who are immunocompromised, in particular those with either HIV infection or
renal failure. The time for boosting in such persons should be decided by regular
monitoring of anti-HBs levels at 6- to 12-monthly intervals.72
those in whom a poor response to hepatitis B vaccination may occur (e.g.

haemodialysis patients, persons with bleeding disorders vaccinated via the
SC route)
sexual partners and household, or other close household-like, contacts of
persons who are infected with hepatitis B.30
For these individuals, if adequate anti-HBs levels (10mIU/mL) are not reached
on serological testing 4 to 8 weeks after the 3rd dose, the possibility of HBV
infection, including chronic HBV infection, should be investigated by testing for
serological markers, including HBsAg and anti-HBc antibodies. In select cases
in which hepatitis B infection is suspected, HBV nucleic acid testing may also be
indicated, and expert advice regarding further management should be sought.
If there are no markers of HBV infection, the individual should be managed
as a non-responder to hepatitis B vaccination (see Non-responders to primary
vaccination below).
If persons who are at significant risk of hepatitis B (such as healthcare workers)
were not tested for anti-HBs within 4 to 8 weeks after completion of the
documented primary course, they should still undergo serological testing to
ensure immunity. If, on testing, they have an anti-HBs level of <10mIU/mL,
they should be given a single booster dose (4th dose) of vaccine. Persons with
immune memory established from effective prior vaccination should respond
to this booster dose. Anti-HBs should be checked 4 weeks later, and if the antiHBs level remains <10mIU/mL, the possibility of HBV infection should be
investigated (and, if excluded, the person should be managed as a non-responder
to vaccination, see below). If the anti-HBs level is 10mIU/mL, the person can be
regarded as immune.
Non-responders to primary vaccination

A non-responder is a person without HBV infection who has a documented
history of an age-appropriate primary course of hepatitis B vaccine, but with a
current anti-HBs level <10mIU/mL. There are a number of potential options for
non-responders. Persons who do not respond to the primary vaccination course,
and in whom chronic HBV infection has been excluded, should be offered further
doses.
As discussed above, in Serological testing following hepatitis B vaccination, a
single booster dose (4th dose) of vaccine can be given to confirm non-responder
status. Persons who are non-responders after being given the booster/4th dose
(and in whom HBV infection has been excluded) should have 2 further doses of
hepatitis B vaccine at monthly intervals, and be re-tested for anti-HBs levels at
least 4 weeks after the last dose. The booster/4th dose that was received could be
counted as the 1st of the 3 repeat doses, as recommended for non-responders. A
few small studies have reported attainment of seroprotection in non-responders
with high-dose formulations or double-dose administration for a 4th, or
subsequent, dose of hepatitis B vaccination, but there is no consistent evidence
to suggest that a higher proportion of subjects would respond with these higherdose regimens.80-82
Persistent non-responders should be informed that they should be considered

not protected against hepatitis B and should minimise exposures. They should
also be informed about the need for HBIG within 72 hours of parenteral or
mucosal exposure to HBV (see Table 4.5.3).

Hepatitis B vaccine is not routinely recommended for pregnant or breastfeeding
women. However, the WHO states that neither pregnancy nor breastfeeding is a
contraindication to the use of this vaccine.86
The only absolute contraindications to hepatitis B vaccines are:
anaphylaxis following a previous dose of any hepatitis B vaccine
In particular, hepatitis B vaccines are contraindicated in persons with a history of
anaphylaxis to yeast.

Extensive experience indicates that the birth dose of hepatitis B vaccine is
very well tolerated by newborn infants. It does not interfere with either the
establishment or maintenance of breastfeeding, and it is not associated with
an increased risk of either fever, medical investigation for sepsis, or serious
outcomes in newborns who were vaccinated compared with the unvaccinated.87-89
Adverse events after hepatitis B vaccination are transient and minor, and include
soreness at the injection site (5%), fever (usually low grade; 23%), nausea,
dizziness, malaise, myalgia and arthralgia. Fever can be expected in some
neonates following immunisation with hepatitis B vaccine (0.63.7%).
Anaphylaxis has been reported very rarely in adults, notably in yeast-sensitive
individuals.90 Although various adverse events such as demyelinating diseases,
4.5 HEPATITIS B
For HBsAg-negative healthcare workers who are non-responders to a primary

course of vaccination and to subsequent additional IM doses (5 doses in total),
some small observational studies report that some individuals may respond
to the vaccine administered intradermally.83-85 Engerix-B (0.25mL [5g] per
dose) was used in these studies, giving up to 4 doses.83 Younger age and longer
duration (6 months) since the last IM dose may be associated with greater
probability of response.84 If an intradermal dose(s) is given, it is recommended
that the anti-HBs levels be measured before each subsequent dose to assess for
seroconversion.
Guillain-Barr syndrome and arthritis have been reported, there is no evidence of

a causal relationship with hepatitis B vaccination.90,91
The World Health Organization Global Advisory Committee on Vaccine Safety
states that multiple studies and review panels have concluded that there is no
link between MS [multiple sclerosis] and hepatitis B vaccination.92,93
The vaccine produces neither therapeutic effects nor adverse events in persons
with chronic HBV infection. It is also safe, though of no additional benefit, in
those already immune to hepatitis B through past natural infection.
4.5.11 Public health management of hepatitis B

Acute hepatitis B and newly identified chronic hepatitis B are notifiable diseases
in all states and territories in Australia.
Further instructions about the public health management of hepatitis B,
including management of cases of acute hepatitis B and newly identified chronic
hepatitis B, and their contacts, should be obtained from state/territory public
health authorities (see Appendix 1 Contact details for Australian, state and territory
Following significant exposure (percutaneous, ocular or mucous membrane) to
blood or to potentially blood-contaminated secretions, where feasible, the source
individual should be tested for HBsAg as soon as possible.
If the person exposed has not been previously vaccinated against hepatitis B,
their anti-HBs level, and anti-HBc and HBsAg status, should be determined
immediately. If the person exposed is anti-HBs and anti-HBc negative (nonimmune) and the source is either HBsAg-positive or cannot be identified and
tested rapidly, a single dose of HBIG should be administered according to
the recommendations in Table 4.5.3. The dose of HBIG is 100IU for children
weighing up to 30kg (about 5 years of age) and 400IU for all others. Hepatitis B
vaccine must also be given as soon as possible, with further doses as
recommended in Table 4.5.3.
For previously vaccinated persons exposed to either an HBsAg-positive source
or a source whose hepatitis B status cannot be determined, post-exposure
prophylaxis is not necessary if there was a documented protective response (antiHBs level 10mIU/mL) at any time after vaccination. If the response to previous
vaccination is unknown, the anti-HBs level should be determined as quickly as
possible. If the anti-HBs level is <10mIU/mL and there is no evidence of HBV
infection, HBIG and HBV vaccine should be administered as per Table 4.5.3.
All healthcare workers should be immunised against hepatitis B. Completion
of a full course of hepatitis B vaccination is strongly recommended for any nonimmune healthcare worker who has sustained a needle-stick injury or other
potential hepatitis B exposure.
Table 4.5.3: P
ost-exposure prophylaxis for non-immune persons exposed to a
HBsAg-positive source
Hepatitis B immunoglobulin
Vaccine
Perinatal
(exposure of
babies during and
after birth)*
100 IU, by
IM injection
Single dose
immediately
after birth
(preferably
within 12
hours of birth
and certainly
within 48
hours)
0.5 mL, by IM
injection
Immediately after birth

(preferably within 24
hours, no later than 7
days), then at 2, 4 and
6 months of age
Percutaneous,
ocular or mucous
membrane
400 IU, by
IM injection
Single dose
within 72
hours of
exposure
0.5 mL or 1 mL
(depending
on age), by IM
injection
Within 7 days of
exposure and at 1 and 6
months after 1st dose
Sexual
400 IU, by
IM injection
Single dose
within 72
hours of last
sexual contact
0.5 mL or 1 mL
(depending
on age), by IM
injection
Within 14 days and at

1 and 6 months after
1st dose
100 IU,
if body
weight
<30 kg
* See also Management of infants born to mothers who are HBsAg-positive above.
The 1st dose can be given at the same time as HBIG, but should be administered at a separate
site. Administration as soon as possible after exposure is preferred.
There is limited evidence for efficacy if given within 14 days of contact; however, administration
as soon as possible after exposure is preferred.
Hepatitis B Immunoglobulin-VF CSL Limited. 160mg/mL

immunoglobulin (mainly IgG) prepared from human plasma
containing high levels of antibody to surface antigen of the hepatitis B
virus. Single vials contain 100IU or 400IU hepatitis B antibody, with
the actual volume stated on the label on the vial. Also contains glycine.
Hepatitis B immunoglobulin (HBIG) is prepared from plasma donated through

routine blood bank collection. Samples are selected on the basis that they contain
high levels of anti-HBs antibodies. As stocks of HBIG are very limited, use
should be strictly reserved for those who are at high risk, such as babies born to
mothers with chronic HBV infection and non-immune persons who are exposed
through occupational exposure to the blood of unidentified persons or to persons
who are chronically infected with hepatitis B or whose hepatitis status cannot be
ascertained in time.86 Requests should be directed to the Australian Red Cross
Blood Service in your state/territory (see 5.1.1 Availability of immunoglobulins in
Part 5 Passive immunisation).
4.5 HEPATITIS B
Type of exposure

The product information for Infanrix hexa states that this vaccine is
contraindicated in children with encephalopathy of unknown aetiology or with
neurologic complications occurring within 7 days following a vaccine dose.
The ATAGI recommends instead that the only contraindication is a history of
anaphylaxis to a previous dose or to any of the vaccine components.
References
4.6.1 Virology
Human papillomaviruses (HPVs) are small, non-enveloped viruses with circular
double-stranded DNA. HPVs infect and replicate primarily within cutaneous
and mucosal epithelial tissues.
More than 100 HPV genotypes have been identified based on sequence variations
in the major genes. They differ in their preferred site of infection; approximately
40 HPV types infect the anogenital tract. Some HPV types, including types 16,
18, 31, 33, 35, 45, 52 and 58, are designated as high-risk, as they are causally
associated with the development of cancer. Other HPV types, including types
6, 11, 40, 42, 43, 44, 54, 61, 70, 72, 81 and 89, have been classified as low-risk
and are predominantly associated with non-malignant lesions, such as genital
warts. The other types are uncommon and their associations with disease are
undetermined, but they are not currently believed to be significant causes of
cancer.1,2

Transmission of anogenital HPV occurs primarily through sexual intercourse;
however, virus transmission can less commonly occur following non-penetrative
sexual contact.3 Perinatal transmission of HPV can cause laryngeal infection in
infants, rarely resulting in recurrent respiratory papillomatosis.4 HPV infection is
often subclinical, but, dependent upon the infecting HPV genotype, may result
in lesions that include cutaneous warts, genital warts, respiratory papillomatosis
(low-risk HPV types), and dysplasias and cancers of the cervix, vulva, vagina,
penis, anus, and the oral cavity and oropharynx (high-risk HPV types). Most
genital HPV infections are cleared (no longer detectable via HPV DNA testing)
within 12 to 24 months. In about 3 to 10% of infections, the virus persists. Persons
with persistent HPV infection constitute the at-risk group for development of
HPV-associated cancers.5-7
The causal link between persistent cervical HPV infection and cervical cancer is
well established. The strength of association between HPV infection and other
cancers varies by site and oncogenic HPV type.8
Cellular changes that occur in the cervix as a result of HPV infection are referred
to as cervical intraepithelial neoplasia (CIN). The majority of these changes
regress, but a minority will progress to cervical cancer. Malignant transformation
in the cervix usually occurs 10 to 20 years following infection with high-risk HPV
types, but has been reported to occur in less than 2 years.9
The clinical features of other HPV-associated cancers and their precursor lesions
in the anogenital region and oropharynx vary, and also depend on the anatomical
site. The process of progression of HPV-associated precursor lesions to cancers
in these sites is less well understood than the process in the cervix. Anogenital
warts may present as painless lumps, or with local tenderness, itching or
4.6 HUMAN PAPILLOMAVIRUS
bleeding. Recurrent respiratory papillomatosis is a potentially fatal condition that

usually occurs in childhood, characterised by multiple warty excrescences on the
mucosal surface of the respiratory tract.10
4.6.3 Epidemiology
Infection with HPV is very common in both men and women, with initial
infection occurring close to the time of sexual debut. It is estimated that up to
79% of the general population will be infected with at least one genital type
of HPV at some time in their lives.11,12 A greater number of sexual partners is
consistently found to be associated with an increased risk of HPV acquisition.12
HPV infection rates differ between geographic regions, and estimated
population prevalence of HPV also varies depending on the anatomical site and
the lesions sampled. About two-thirds of Australian women aged 1520 years
participating in cervical screening had HPV DNA detected in cervical samples
collected for cytology.13
Certain population subgroups are identified to be at increased risk of
HPV infection and HPV-associated diseases, compared with the general
population. Infection with multiple HPV genotypes and longer time to clear
infection are commonly observed in men who have sex with men (MSM).14-16
In addition, the prevalence of high-risk HPV types is significantly higher in
HIV-positive MSM than in MSM who are HIV-negative.14 Persons who are
immunocompromised (due to disease or medical treatment) are at increased
risk of HPV-related disease.12
In a serosurvey conducted in Australia in 2006, 24% of females and 18% of males
aged 069 years were seropositive to at least one of the four HPV types 6, 11, 16
and 1817 noting that fewer than 60% of women, and an even lower proportion
of men, who are infected with HPV develop antibodies.18-20 The onset age of
seropositivity for HPV in this study was 1014 years in females and 1519 years
in males. The average age of sexual debut for both males and females in Australia
was 16 years, as reported in 20002002.21 A more recent national survey in 2008
reported that about 80% of senior secondary school children (aged approximately
1519 years) acknowledged having engaged in some form of sexual activity that
may transmit HPV.22
Persistent HPV infection is the necessary precursor for the development
of all cervical cancers.23 Worldwide, approximately 70% of cervical cancers
contain HPV-16 DNA and 16% contain HPV-18 DNA.24,25 Australian data
indicate that HPV-16 and HPV-18 are responsible for approximately 60% and
20%, respectively, of cervical cancers, and 37% and 8%, respectively, of highgrade cervical abnormalities.26,27 In Australia, cervical cancer ranked 22nd in
the overall cancer disease burden in 2008 and now occurs predominantly in
women unscreened or under-screened through the National Cervical Screening
Program.28,29 In 2007, the age-standardised incidence rate of cervical cancer in
Australia was 6.8 per 100 000, and the mortality rate was 1.8 deaths per 100 000
The proportion of cancers of other anogenital sites that is attributable to HPV

ranges from approximately 40% for vulval cancers to approximately 85% for
anal cancers. More than 85% of these HPV-associated cancers have evidence of
infection due to the high-risk HPV types 16 and 18.31-36
In Australia in 2007, incidence rates of vulval and vaginal cancers in women were
2.6 per 100 000 (n=276) and 0.65 per 100 000 (n=69), respectively.28 The incidence
rate of penile cancer was 0.8 per 100 000. The age-standardised incidence rate
for anal cancer was 1.3 per 100 000; however, a slightly higher incidence was
observed in females than in males. Overall, anal cancer incidence has been
steadily increasing over the past few decades; however, the increase has been
greater in males than in females.31,34 The mortality rates for vulval, vaginal, penile
and anal cancers were all less than 0.6 per 100 000.28
MSM have a significantly higher incidence of high-grade anal intraepithelial
neoplasia and anal cancer than the general population. Overseas studies have
found a greater than 30-fold higher incidence of anal cancer in MSM than in
other men.37,38
There is wide variability in the reported proportions of oropharyngeal cancers
associated with HPV, ranging from 12% to 63%, and a lower proportion of oral
cancers.39-41 Of the cancers at these sites that are HPV-positive, HPV-16 and/or
HPV-18 account for more than 85%. In Australia, similar to the United States and
other western countries, there has been a steady increase in the burden of HPVpositive oropharyngeal cancers (mainly attributable to cancers of the base of the
tongue and tonsils) over the past few decades.31,39,42-45
The population incidence of benign HPV-associated lesions, such as anogenital
warts, is much higher than the incidence of HPV-associated cancers. In Australia,
the estimated annual incidence of anogenital warts in 20002006 was 206 per
100 000 in males and 231 per 100 000 in females. The age group of peak incidence
was 2529 years for men (rate 740 per 100 000) and 2024 years for women (rate
861 per 100 000).46 In Australia, 4.0% of men and 4.4% of women aged 1659
years reported ever being diagnosed with genital warts,47 and the estimated
cumulative lifetime risk of genital warts was 10%.48,49 The estimated incidence of
women. The prevalence of high-risk HPV types 16 and 18, detected when
cervical samples collected for cytology were tested for HPV DNA, was similar
between Indigenous and non-Indigenous women.13 However, the incidence rate
of cervical cancer in Aboriginal and Torres Strait Islander women is almost 3
times higher than in non-Indigenous Australian women, an indication of lower
participation rates in cervical screening programs by Indigenous Australians and
greater prevalence of cofactors for cervical cancer such as smoking, earlier and
more pregnancies, and lower socioeconomic status.13,28,30 Indigenous women are
5 times more likely to die from cervical cancer than non-Indigenous women.28
Also, Australians in remote and very remote areas have 1.5 times higher cervical
cancer incidence than those living in major cities.28
anogenital warts in MSM is about 10 times higher than in the general population,
with a third of HIV-negative MSM reporting a history of these lesions.46,50 HPV
types 6 and 11 are associated with 90% of genital warts.51,52
Recurrent respiratory papillomatosis is a rare (incidence approximately 3.5 per
100 000) and predominantly childhood disease that is associated with HPV types
6 and 11 in 100% of cases.52-54
In 2007, the HPV Vaccination Program, funded under the NIP, was introduced.
This initially included universal vaccination of girls aged approximately
1213 years, delivered through an ongoing school-based program. It also
included a catch-up program for females up to 26 years of age, which ceased at
the end of 2009. In 2013, the program will be extended to include HPV vaccine
for boys aged approximately 1213 years, together with a 2-year catch-up
program for Year 9 boys. Although the impact of HPV vaccination on cancer
incidence will take decades to occur, early surveillance data have shown an
impact on the incidence of genital warts and CIN in the years following the
introduction of the female vaccination program.55-58 A study including eight
sexual health centres showed a 59% decrease in the proportion of vaccineeligible female first-time clinic attendees diagnosed with genital warts.56 This
study also demonstrated that vaccination of females results in some herd
immunity benefits to males, with a significant decline in the diagnosis of genital
warts observed in unvaccinated males of the same age.55,56,58 In addition to
reduction in genital warts, Victorian data have demonstrated a 48% decline in
the incidence of high-grade cervical abnormalities in girls aged <18 years in the
years after the introduction of the HPV Vaccination Program.57 National cervical
screening data are also indicating a decline in high-grade lesions diagnosed in
women aged <20 years.29
4.6.4 Vaccines
There are two HPV vaccines registered for use in Australia: the bivalent vaccine
(2vHPV; Cervarix), which contains virus-like particles (VLPs) of HPV types 16
and 18; and the quadrivalent vaccine (4vHPV; Gardasil), which contains VLPs of
HPV types 16, 18, 6 and 11. VLPs are not infectious and do not replicate or cause
cellular abnormalities.59,60
Cervarix GlaxoSmithKline (recombinant protein particulate [VLP]

vaccine containing the major capsid [L1] protein of HPV types 16 and
18; 2vHPV). Each 0.5mL monodose vial or pre-filled syringe contains
20g HPV-16 L1 protein and 20g HPV-18 L1 protein, adjuvanted
with AS04 (comprised of 0.5mg aluminium hydroxide and 50g
3-O-desacyl-4-monophosphoryl lipid A [MPL]).
The 2vHPV and 4vHPV vaccines have been assessed in females in a number
of international clinical trials. When given as a 3-dose series, HPV vaccines
elicit a neutralising antibody level many times higher than the level observed
following natural infection.61,62 Overall, seroconversion occurs in 97 to 100%
of those vaccinated.63-65 In women who are nave to HPV types 16 and 18 prior
to vaccination, both vaccines are highly effective at preventing type-specific
persistent infection and related cervical disease (approximately 90 to 100%).66-71
The 4vHPV vaccine also has established efficacy (100%; 95% CI: 94100%)
against external anogenital and vaginal lesions (genital warts, and vulval,
vaginal, perineal and perianal dysplasias) associated with HPV types 6, 11,
16 or 18 in women.
In women who are vaccinated irrespective of their baseline HPV status (i.e.
women who may have pre-existing HPV infection), vaccine efficacy is lower than
observed in HPV-nave women, indicating reduced vaccine effectiveness among
women who are already sexually active. This is because both HPV vaccines are
prophylactic vaccines (i.e. preventing primary HPV infection). Vaccination will
not treat an existing HPV infection or prevent disease that may be caused by an
existing HPV vaccine-type infection.63,72,73 However, vaccination may still provide
benefit for sexually active women by protecting them against new infections with
other vaccine-preventable HPV types.
The efficacy of 4vHPV in males aged 1626 years has been demonstrated
in one clinical trial.74 Vaccination was greater than 85% protective against
persistent anogenital infection and external genital lesions due to vaccine HPV
types among HPV-nave participants. Among HPV-nave MSM participants
within the clinical trial, vaccine efficacy was 95% against intra-anal HPV
infection and 75% against high-grade anal intraepithelial neoplasia from
vaccine HPV types. Efficacy of 2vHPV vaccine in males has not been assessed
to date; however, the vaccine has demonstrated safety and immunogenicity in
males aged 1018 years.75
There is some evidence of HPV vaccine providing some cross-protection to
disease due to other HPV types in women: 4vHPV vaccine against cervical
Gardasil CSL Limited/Merck & Co Inc (recombinant protein

particulate [VLP] vaccine containing the major capsid [L1] protein
of HPV types 6, 11, 16 and 18; 4vHPV). Each 0.5mL monodose
vial or pre-filled syringe contains 20g HPV-6 L1 protein, 40g
HPV-11 L1 protein, 40g HPV-16 L1 protein and 20g HPV-18
L1 protein, adsorbed onto 0.225mg of aluminium as aluminium
hydroxyphosphate sulphate; 0.780mg L-histidine; 50g polysorbate
80; 35g sodium borate. May also contain yeast proteins.
disease due to HPV types 31 and 4576 and 2vHPV vaccine against cervical disease
due to HPV types 31, 33, 45 and 51.77 However, the level of protection is less than
for the vaccine HPV types and the durability of any such protection is unknown.
Efficacy of HPV vaccines in females or males <16 years of age was not assessed
in pre-market trials due to the genital sampling requirements of such studies.
However, the antibody responses observed in pre-adolescent and adolescent
females and males (>9 years of age) were greater than those in adult women and
men, in whom clinical efficacy has been demonstrated for both the 4vHPV and
2vHPV vaccines.
It is not certain how long immunity following HPV vaccination persists, or
whether a booster dose after the primary course will ever be required. However,
long-term population-based follow-up studies to assess this are underway.78
In clinical trials, vaccine efficacy has been demonstrated up to at least 5 years
for 4vHPV vaccine and 9.4 years for 2vHPV vaccine in women, with no
breakthrough disease due to vaccine HPV types.61,79,80
Variations in vaccination schedules for both HPV vaccines are being assessed
in clinical trials. A recent study showed a lesser immune response in a schedule
with a dose interval of 12 months between each of the 3 doses of 4vHPV vaccine
compared with schedules with dose intervals of 6 months or less between each of
the doses.81 However, a recent study of 2vHPV following an alternative schedule
(0, 1 and 12 months) demonstrated that the immunogenicity of vaccine HPV
types was non-inferior following this schedule, compared with the standard
schedule (measured 1 month after the final dose).82 Two-dose schedules of both
2vHPV and 4vHPV are also being studied.83,84


The dose of both HPV vaccines is 0.5mL to be given by IM injection.
The primary vaccination course for both HPV vaccines consists of 3 doses.
The recommended schedule for the 2vHPV vaccine is at times 0 (the day the
1st dose is given), 1 and 6 months. The 2vHPV vaccine is registered for use in
females aged 1045 years. The 2vHPV vaccine is not registered for use in males
of any age.
The recommended schedule for the 4vHPV vaccine is at times 0 (the day the
1st dose is given), 2 and 6 months. The 4vHPV vaccine is registered for use in
females aged 945 years and in males aged 926 years. However, there are no
theoretical concerns that the efficacy or safety of 4vHPV vaccine in males up
to the age of 45 years will differ significantly from females of the same age or
younger males.
Where vaccines have been administered at less than the minimum intervals (see
Table 2.1.12 Catch-up schedule for persons 10 years of age (for vaccines recommended
on a population level)), contact your state or territory health department for
guidance. See also Chief Medical Officer Guidance available at www.health.gov.
au/internet/immunise/publishing.nsf/Content/cmo-full-advice-hpv-cnt.

Both HPV vaccines can be given concomitantly with reduced antigen content
diphtheria-tetanus-acellular pertussis (dTpa) or diphtheria-tetanus-acellular
pertussis-inactivated poliomyelitis vaccine (dTpa-IPV), and hepatitis B vaccine
(monovalent).86-90 There are no clinical data regarding concomitant administration
of either HPV vaccine with varicella vaccine, but there are no theoretical concerns
about safety or efficacy of the vaccines if they are given simultaneously, using
different injection sites.
Interchangeability of human papillomavirus vaccines

There are currently no clinical data available on the interchangeability of the
two HPV vaccines. However, from first principles, acceptable antibody levels
and protection against HPV-16 and 18 (the types that are shared by both these
vaccines and that are the dominant causes of cervical cancer) would be expected
following a combination schedule.
It is recommended that an HPV vaccination course commenced with one vaccine
should, wherever possible, be completed with that vaccine and according to its
recommended schedule.
Where the course includes a combination of the two HPV vaccines, either
inadvertently or because of an adverse event following one vaccine, the person
is considered to be fully immunised against HPV-16 and 18 disease if a total of
3 doses of HPV vaccine have been given, provided that the minimum interval
requirements between the doses are satisfied. Every effort should be made to
complete a 3-dose schedule for effective protection against disease due to each of
the vaccine HPV types.
Neither HPV vaccine is registered or recommended for use in children <9 years
of age.
Females
Both the 4vHPV and 2vHPV vaccines are recommended for use in females for
prevention of persistent infection and anogenital disease caused by HPV types 16
and 18. The 4vHPV vaccine also provides protection against vaccine-type genital
warts (which are mostly caused by HPV types 6 and 11). (See also 4.6.4 Vaccines
above.)
If scheduled doses have been missed, there is no need to repeat earlier doses.
The missed dose(s) should be given as soon as is practicable, making efforts to
complete doses within 12 months.
Children and adolescents aged 918 years
HPV vaccine is recommended for females 918 years of age. The optimal age
for administering the HPV vaccine is approximately 1113 years, as most
females in this age group would not have commenced sexual activity and so
would be nave to all HPV types. Vaccination only provides protection against
vaccine-type disease if the vaccine is delivered prior to acquisition of that HPV
type. Therefore, the decision to vaccinate older adolescent females, who may
have already commenced sexual activities, should follow an assessment of the
potential benefits, based on their likely previous HPV exposure and future risks
of HPV exposure.
Either of the HPV vaccines can be used for adolescent females. The 2vHPV
vaccine is only registered for use in girls 10 years of age.
Vaccination of all women in this age group is not routinely recommended, as

many are likely to have been exposed to one or more vaccine HPV types through
sexual activity (see 4.6.3 Epidemiology above).
However, some adult females may gain an individual benefit from HPV
vaccination. The decision to vaccinate older females should take into account
their likelihood of previous exposure to HPV and their future risks of HPV
exposure.
Males
The 4vHPV vaccine is recommended for use in males for prevention of persistent
infection and anogenital disease caused by HPV types 6, 11, 16 and 18. The
4vHPV vaccine also provides protection against vaccine-type genital warts
(which are mostly caused by HPV types 6 and 11). (See also 4.6.4 Vaccines above.)
Children and adolescents aged 918 years
The 4vHPV vaccine is recommended for males 918 years of age. The optimal
age for administering the 4vHPV vaccine is approximately 1113 years, as most
males in this age group would not have commenced sexual activity and so
would be nave to all HPV types. Vaccination only provides protection against
vaccine-type disease if the vaccine is delivered prior to acquisition of that HPV
type. Therefore, the decision to vaccinate older adolescent males, who may
have already commenced sexual activities, should follow an assessment of the
potential benefits, based on their likely previous HPV exposure and future risks
of HPV exposure.
Vaccination of all men in this age group is not routinely recommended as many
are likely to have been exposed to one or more vaccine HPV types through sexual
activity (see 4.6.3 Epidemiology above).
Men who have sex with men
The 4vHPV vaccine is recommended for men who have sex with men (MSM)
who have not previously been vaccinated with 3 doses of HPV vaccine. The
decision to vaccinate males in this group should take into account their likelihood
of previous exposure to HPV and their future risks of HPV exposure. Overall,
MSM are at increased risk of persistent HPV infection and associated disease
(independent of HIV status or the presence of other immunocompromising
conditions).14,38 In addition, at the population level, MSM are less likely to benefit
from herd immunity attained from HPV vaccination of females. The safety and
efficacy of 4vHPV vaccine has been demonstrated in MSM participants in a
randomised clinical trial (see 4.6.4 Vaccines above).
Persons who are immunocompromised

HPV vaccine is recommended for adult men and women who are
immunocompromised due to medical conditions (including HIV infection) or
treatment. The decision to vaccinate immunocompromised persons should take
into account their likelihood of previous exposure to HPV, their future risks
of HPV exposure, and the extent and duration of their immunocompromise
(see 3.3.3 Vaccination of immunocompromised persons). Immunocompromised
adolescents who have not yet been vaccinated with 3 doses of HPV vaccine
should be offered catch-up vaccination. This is based on evidence that persons
who are immunocompromised are more likely to develop a persistent HPV
infection and to subsequently progress to HPV-related disease.14,91
There are currently no clinical trial data demonstrating the efficacy of either of
the HPV vaccines in immunocompromised participants. However, 4vHPV has
been shown to be well tolerated and immunogenic in HIV-infected males and
women with systemic lupus erythematosus.92-94 As HPV vaccines are not live
viral vaccines, there are no specific safety concerns regarding administration
to immunocompromised persons (see 3.3.3 Vaccination of immunocompromised
persons).
Cervical screening in vaccinated females

For all sexually active women, regular cervical screening remains an important
preventive measure against cervical disease (refer to the National Cervical
Screening Program at www.cancerscreening.gov.au). Vaccination is not an
alternative to cervical screening but is a complementary preventive measure, as
HPV types other than those included in the current vaccines have the potential
to cause cervical cancer. Likewise cervical screening is not an alternative to HPV
vaccination. Both are recommended.
However, some adult males may gain an individual benefit from HPV
vaccination. The decision to vaccinate older males should take into account their
likelihood of previous exposure to HPV and their future risks of HPV exposure.
Cervical screening detects histopathological changes. It is not recommended to

test for the presence of HPV virus or antibody routinely as a way of determining
whether HPV vaccination is indicated.
For women who have recently been diagnosed with cervical dysplasia, or have
been treated for this in the past, HPV vaccine will have no impact on current
disease, but may prevent future dysplasia due to different HPV types included in
the vaccine.

HPV vaccines are not recommended for pregnant women.
Women who become pregnant after starting the HPV vaccination course should
withhold getting further doses of the HPV vaccine while pregnant, and receive
the remaining doses of the course after pregnancy.
Females who inadvertently receive a dose of HPV vaccine around the time of
conception or during pregnancy should be informed of the body of evidence
supporting lack of harm from vaccine administration in this setting. Among
women who became pregnant during the course of 4vHPV vaccine clinical trials
(despite recommendations for participants to avoid pregnancy), the overall
proportions of pregnancies that resulted in an adverse outcome (spontaneous
abortion, late fetal death, infant with congenital anomalies) were similar among
4vHPV vaccine recipients and placebo or control vaccine recipients. Although
one clinical trial raised the possibility of an association between 4vHPV vaccine
administered within 30 days following the estimated date of conception and an
increased incidence of congenital anomalies in the infant, those conditions were
relatively common and unrelated.72 Pooled analyses from multiple clinical trials
have not confirmed such an association.95
Pooled analysis of women who became pregnant during clinical trials showed
that, overall, there were no differences in pregnancy outcomes between 2vHPV
vaccine and control vaccine recipients.96,97
HPV vaccines can be given to breastfeeding women. Among breastfeeding
mothers in the clinical studies of 4vHPV vaccine, the rates of adverse events
in the mother and the breastfeeding infant were comparable between 4vHPV
vaccine and control vaccination groups.98 The effect on breastfed infants of
the administration of 2vHPV vaccine to their mothers has not been evaluated
directly in clinical studies, but breastfeeding is not considered a contraindication
for receiving the 2vHPV vaccine.
The only absolute contraindications to HPV vaccines are:

anaphylaxis following a previous dose of either HPV vaccine
In particular, the 4vHPV vaccine is contraindicated in persons with a history of
anaphylaxis to yeast.

Both the 2vHPV and 4vHPV vaccines are generally safe and well tolerated.
For both vaccines, injection site pain was the most commonly reported adverse
event (approximately 80% of recipients), followed by swelling and erythema
(2030% for each). Injection site reactions were more commonly reported in
vaccine recipients than in recipients of aluminium-containing placebo or control
vaccines in clinical trials. Systemic reactions were also very common following
both vaccines, occurring in up to about 30% of recipients. The most common
adverse events included headache, fatigue, fever and myalgia. In most of the
clinical trials, the frequencies of most of these common systemic adverse events
were comparable between the HPV vaccine and the control vaccine recipients.
Meta-analyses on pooled data from multiple clinical trials on both the 2vHPV
and 4vHPV vaccines have shown no increase in the risk of serious adverse events
among vaccine recipients compared with control recipients.99,100
For both vaccines, the safety profile and the spectrum of adverse events
following immunisation in males were similar to those reported in females of
corresponding age groups,74,75,101,102 although some of the studies were not direct
comparison studies.
Post-marketing passive surveillance of HPV vaccine use in the United States has
identified syncope (fainting) as one of the most common adverse events reported
following 4vHPV vaccine in adolescent and young adult females.103 A small
proportion (about 10%) of syncopal episodes resulted in a fall with head injury.103
Similar or higher rates of syncope have been reported in other countries, through
different surveillance mechanisms.104,105 However, a prospective adverse events
surveillance study in the United States, based on over 600 000 records of vaccine
doses administered, did not find any increased risk of syncope with 4vHPV
vaccination compared to the expected rate following non-4vHPV vaccination in
youths and adults.106 Syncope (fainting) may follow any vaccination, especially
in adolescents and young adults, but is preventable through appropriate
precautions. (See also 2.3.2 Adverse events following immunisation). In an Australian
study, 22 subjects (including 14 with syncope and 8 with syncopal seizure
following 4vHPV vaccination) were reviewed in a Victorian clinic and received
further doses while supine; no recurrence of syncope occurred.104
Anaphylaxis and other suspected hypersensitivity reactions, including skin
rash, after 4vHPV vaccine have also been reported. The estimated incidence
rate of anaphylaxis following 4vHPV vaccine in Australia, as at June 2010, was

2.6 anaphylaxis episodes per million doses of vaccine distributed, which was
within the rate range for other vaccines given to children and adolescents in
international studies.107 A prospective surveillance study in the United States
did not find any increased risk of anaphylaxis or allergic reactions with 4vHPV
vaccination compared to the expected rate following childhood vaccines.106

The product information for the 4vHPV vaccine, Gardasil, states that this
vaccine is indicated for use in males up to 26 years of age and females up to
45 years of age. The product information for the 2vHPV vaccine, Cervarix,
states that this vaccine is indicated for use in females up to 45 years of
age and is not registered for use in males of any age. The ATAGI instead
recommends that some males aged >26 years, such as MSM and those who are
immunocompromised, who are likely to derive an individual benefit from HPV
vaccination, can be vaccinated with 4vHPV. The ATAGI also recommends that
some females aged >45 years, such as those who are immunocompromised, can
be vaccinated with either 2vHPV or 4vHPV, based on their individual risk of
future HPV exposure and disease.
References
4.7 INFLUENZA
4.7.1 Virology
Both influenza A and influenza B viruses undergo frequent changes in their

surface antigens, involving stepwise mutations of genes coding for H and N
glycoproteins. This results in cumulative changes in influenza antigens, or
antigenic drift, which is responsible for the annual outbreaks and epidemics of
influenza and is the reason that the composition of influenza vaccines requires
annual review. Antigenic shift, defined as a dramatic change in influenza A
H (and other) antigen, occurs occasionally and unpredictably and can cause
pandemic influenza.1 Pandemic subtypes arise following antigenic shift, which
is due to direct adaptation to humans of an avian or animal virus, or to this
adaptation occurring by genetic reassortment (mixing) with a human virus.

Influenza is transmitted from person to person by virus-containing respiratory
aerosols produced during coughing or sneezing, or by direct contact with
respiratory secretions.1,2 Influenza virus infection causes a wide spectrum of
disease, from no or minimal symptoms, to respiratory illness with systemic
features, to multisystem complications and death from primary viral or
secondary bacterial pneumonia. Severe disease is more likely with advanced
age; lack of previous exposure to antigenically related influenza virus; greater
virulence of the viral strain; chronic conditions, such as heart or lung disease,
renal failure, diabetes and chronic neurological conditions; immunocompromise;
pregnancy; and smoking. In pandemics, severe disease may also occur in
otherwise healthy young adults. Annual attack rates in the general community
are typically 5 to 10%, but may be up to 20% in some years. In households
and closed populations, attack rates may be 2 to 3 times higher.3,4 However,
as asymptomatic or mild influenza illness is common and symptoms are nonspecific, a large proportion of influenza infections are not detected.
In adults, the onset of illness due to influenza is often abrupt, usually after an
incubation period of 1 to 3 days, and includes systemic features such as malaise,
feverishness, chills, headache, anorexia and myalgia. These may be accompanied
by a cough, nasal discharge and sneezing. Fever is a prominent sign of infection
4.7 INFLUENZA
The influenza viruses are single-stranded RNA orthomyxoviruses. They are

classified antigenically as types A, B or C, but only influenza A and B are
clinically important in human disease.1 Influenza viruses possess two surface
glycoprotein antigens: the haemagglutinin (H), which is involved in cell
attachment during infection, and the neuraminidase (N), which facilitates the
release of newly synthesised virus from the cell. Influenza A viruses can be
classified into subtypes based on differences in these surface antigens, whereas
influenza B cannot. Antibody against the surface antigens, particularly the
haemagglutinin, reduces infection or severe illness due to influenza.
and peaks at the height of the systemic illness. Symptoms are similar for
influenza A and B viruses. However, infections due to influenza A (H3N2)
strains are more likely to lead to severe morbidity and increased mortality than
influenza B or seasonal influenza A (H1N1) strains.1,2
The clinical features of influenza in infants and children are similar to those
in adults. However, temperatures may be higher in children (and may result
in febrile convulsions in this susceptible age group), and otitis media and
gastrointestinal manifestations are more prominent.5 Infection in young infants
may be associated with more non-specific symptoms.5,6
Complications of influenza include: acute bronchitis, croup, acute otitis
media, pneumonia (both primary viral and secondary bacterial pneumonia),
cardiovascular complications including myocarditis and pericarditis,
post-infectious encephalitis, Reye syndrome, and various haematological
abnormalities. Primary viral pneumonia occurs rarely, but secondary bacterial
pneumonia is a frequent complication in persons whose medical condition makes
them vulnerable to the disease. Such persons are at high risk in epidemics and
may die of pneumonia or cardiac decompensation.
4.7.3 Epidemiology
In most years, minor or major epidemics of type A or type B influenza occur,
usually during the winter months in temperate regions. In Australia, although
an average of 85 deaths and approximately 4000 hospitalisations directly
attributed to influenza are notified annually, it has long been recognised that
this is a substantial underestimate of the impact of influenza.7 It is estimated that
there are an average of over 13 500 hospitalisations due to influenza per year in
Australia and over 3000 deaths per year in Australians aged over 50 years alone.8
Influenza activity varies from year to year and is dependent on the circulating
virus and the susceptibility of the population.8,9 For example, there were over
10 000 confirmed cases of influenza reported to the National Notifiable Diseases
Surveillance System in the first half of 2011, compared with approximately 1570
for the same period in 2010.2 Laboratory testing for influenza has also increased
in recent years. In Australia, like other developed countries, the highest influenza
burden is seen in the elderly and in children <5 years of age (Figure 4.7.1).9-11
During annual epidemics of influenza, mortality rises, especially among the
elderly and people with chronic diseases, and there is increased morbidity,
increased rates of hospitalisation for pneumonia, and exacerbation of chronic
diseases in association with influenza.12,13
Figure 4.7.1: Influenza notification rates 20062007* and hospitalisation rates

20052007,* Australia, by age group9
Rate per 100 000 population
100
80
60
4.7 INFLUENZA
250
Notifications
200
Hospitalisations
150
100
50
0
0
2
3
Age (years)
40
85
8084
7579
7074
6569
6064
5559
5054
4549
4044
3539
3034
2529
2024
1519
1014
59
20
04
120
Age (years)
* Notifications where the month of diagnosis was between January 2006 and December 2007;
hospitalisations where the month of separation was between July 2005 and 30 June 2007. These
data are prior to the appearance of the pandemic A(H1N1)pdm09 virus in 2009.
Three pandemics were recognised in the 20th century, in 1918 (H1N1),

1957 (H2N2) and 1968 (H3N2). Each of these pandemic strains replaced the
previously circulating influenza A subtype and went on to circulate as seasonal
influenza. In 1977, the A (H1N1) re-emerged in the human population and, since
then, A (H1N1) and A (H3N2) have co-circulated with influenza B. Recently,
the avian influenza A virus subtypes, H5N1 and H9N2, have caused human
infections. The most notable of these is the A (H5N1) subtype, which has become
established in domestic poultry throughout Southeast Asia and has spread to
Europe and Africa in either wild birds or domestic poultry. Although growing
numbers of people have contracted the virus by contact with birds and there is
a high mortality rate (50%), there has been no evidence of ongoing person-toperson transmission.
In 2009, the World Health Organization (WHO) declared a pandemic of a novel
subtype A (H1N1) influenza virus, A(H1N1)pdm09, which originated in swine;
the pandemic started in Mexico and the United States in April 2009. In August
2010, the WHO reported that more than 214 countries and overseas territories or
communities reported laboratory-confirmed cases of A(H1N1)pdm09 (pH1N1)

influenza, including more than 18 000 deaths.14 In Australia, a total of 44 403
confirmed cases of pH1N1 influenza occurred between May 2009 and November
2010, including 6767 cases in 2010. A total of 213 pandemic influenza-associated
deaths were reported, 22 of which occurred in 2010.15
Evidence from multiple outbreak sites demonstrated that the A(H1N1)pdm09
virus rapidly established itself and was the dominant influenza strain in most
parts of the world. The clinical picture of pH1N1 influenza appeared to be largely
consistent across all countries, with most affected persons experiencing moderate
illness. Risk factors for severe disease included obesity, pregnancy, diabetes
mellitus and, in Australia, being of Aboriginal or Torres Strait Islander descent
(see 3.1 Vaccination for Aboriginal and Torres Strait Islander people). Although
influenza can cause very severe and fatal illness, particularly in the elderly, the
impact of pH1N1 influenza in younger healthy adults and in pregnant women
was proportionally greater than normal seasonal outbreaks, even though the
absolute number of such cases remained low. During the last quarter of 2009,
Australia introduced a non-adjuvanted, inactivated, egg-derived, monovalent
A(H1N1)pdm09 vaccine for administration to all persons aged 6 months
(Panvax, CSL Limited). Expired monovalent vaccine supplies were withdrawn
in December 2010.16 In Australia, there was ongoing summer activity of A(H1N1)
pdm09 in late 2009, and the virus continued to circulate in 2010 and 2011,
replacing the previously circulating seasonal H1N1 strain.2 The A(H1N1)pdm09
strain was included in trivalent seasonal influenza vaccine formulations used in
the southern hemisphere in 2010, 2011 and 2012.
4.7.4 Vaccines
The administration of influenza vaccine to persons at risk of complications of
infection is the single most important measure in preventing or attenuating
influenza infection and preventing mortality. After vaccination, most adults
develop antibody levels that are likely to protect them against the strains of
virus represented in the vaccine. In addition, there is likely to be protection
against many related influenza variants. Infants, the very elderly, and persons
who are immunocompromised may develop lower post-vaccination antibody
levels. Under these circumstances, influenza vaccine may be more effective
in preventing lower respiratory tract involvement or other complications of
influenza than in preventing influenza infection.
Vaccines for intramuscular administration

Children aged 6 months and adults (see Table 4.7.1 for dosage information for
different age groups)
Agrippal Novartis Vaccines and Diagnostics Pty Ltd (inactivated

influenza virus). Each 0.5mL pre-filled syringe contains 15g
haemagglutinin of each of the three recommended strains. May
contain traces of kanamycin, neomycin, formaldehyde, barium
sulphate, cetrimonium bromide (CTAB), polysorbate 80 and egg
protein.
Fluarix GlaxoSmithKline (inactivated influenza virus). Each 0.5mL
pre-filled syringe contains 15g haemagglutinin of each of the
three recommended strains. May contain traces of formaldehyde,
gentamicin, polysorbate 80, octoxinol 10 and egg protein.
Influvac Abbott Products Pty Ltd (inactivated influenza virus). Each
0.5mL pre-filled syringe contains 15g haemagglutinin of each of
the three recommended strains. May contain traces of formaldehyde,
CTAB, polysorbate 80, gentamicin and egg protein.
Influvac Junior (6 months to <3 years) Abbott Products Pty Ltd
(inactivated influenza virus). Each 0.25mL pre-filled syringe contains
7.5g haemagglutinin of each of the three recommended strains. May
contain traces of formaldehyde, CTAB, polysorbate 80, gentamicin
and egg protein.
Vaxigrip Sanofi Pasteur Pty Ltd (inactivated influenza virus). Each
0.5mL pre-filled syringe contains 15g haemagglutinin of each of
the three recommended strains. May contain traces of formaldehyde,
octoxinol 9, neomycin and egg protein.
Vaxigrip Junior (6 months to <3 years) Sanofi Pasteur Pty Ltd
(inactivated influenza virus). Each 0.25mL pre-filled syringe contains
7.5g haemagglutinin of each of the three recommended strains.
May contain traces of formaldehyde, octoxinol 9, neomycin and
egg protein.
4.7 INFLUENZA
Always check annual seasonal influenza vaccine availability statements

on www.immunise.health.gov.au. Vaccines and age eligibility change
from year to year.
Children aged 10 years* and adults (see Table 4.7.1 for dosage information)
Fluvax CSL Limited (inactivated influenza virus).* Each 0.5mL

pre-filled syringe contains 15g haemagglutinin of each of the three
recommended strains. May contain traces of neomycin, polymyxin B,
-propiolactone, sodium taurodeoxycholate and egg protein.
Fluad Novartis Vaccines and Diagnostics Pty Ltd (inactivated

influenza virus). Each 0.5mL pre-filled syringe contains 15g
haemagglutinin of each of the three recommended strains, adjuvanted
with MF59C.1 (which contains squalene and polysorbate 80). May
contain traces of kanamycin, neomycin, formaldehyde, barium
sulphate, CTAB and egg protein.
Vaccines for intradermal administration

Intanza 9g Sanofi Pasteur Pty Ltd (inactivated influenza virus).

Each 0.1mL pre-filled purpose-designed Micro-Injection System
contains 9g haemagglutinin of each of the three recommended
strains. May contain traces of formaldehyde, octoxinol 9, neomycin
and egg protein.
Intanza 15g Sanofi Pasteur Pty Ltd (inactivated influenza virus).

Each 0.1mL pre-filled purpose-designed Micro-Injection System
contains 15g haemagglutinin of each of the three recommended
strains. May contain traces of formaldehyde, octoxinol 9, neomycin
and egg protein.
* Fluvax (CSL Limited) is registered by the Therapeutic Goods Administration (TGA) for
administration in children 5 years of age; however, it is not recommended for use in children
<10 years of age (see 4.7.11 Adverse events and 4.7.13 Variations from product information below).
The composition of vaccines for use in Australia is determined annually by the

Australian Influenza Vaccine Committee.17 Influenza vaccines normally contain
three recommended strains of virus, two influenza A subtypes and influenza B,
representing currently circulating viruses. The included strains may differ from
those selected for use in the northern hemisphere influenza vaccine formulation.
The final trivalent influenza vaccine contains 15g of viral haemagglutinin (or
9g in Intanza 9g), the principal surface antigen, for each virus strain. Vaccines
specifically packaged for use in children aged 6 months to <3 years contain
7.5g of viral haemagglutinin (in a 0.25mL dose) of each of the same three
strains found in the adult formulations.
Two intradermally administered influenza vaccines from the same manufacturer

(Intanza 9g for use in adults aged 1859 years and Intanza 15g for use in
adults aged 60 years) have been registered in Australia since 2009. These
vaccines are presented in a purpose-designed syringe, the Micro-Injection
System, which will deliver 0.1mL of vaccine to the dermis. These vaccines
demonstrate comparable immunogenicity to influenza vaccines administered
intramuscularly and are likely to have similar efficacy.
Live attenuated intranasal influenza vaccine(s) are not currently registered in
Australia and, worldwide, are not as widely used as the currently available
inactivated influenza vaccines.18,19
The efficacy and effectiveness of different split virion and subunit influenza
vaccines are generally considered equivalent. The efficacy and effectiveness
of influenza vaccine depends primarily on the age and immunocompetence
of the vaccine recipient and the degree of similarity between the virus strains
in the vaccine and those circulating in the community.13,20-27 In children, the
burden of influenza is well documented, but there is less evidence for vaccine
efficacy, particularly in children aged <2 years.22 There have been few vaccine
effectiveness studies undertaken in very young infants and toddlers and these
studies are difficult to compare due to differences in vaccine formulations
and inclusion and exclusion criteria, and the measurement of different clinical
endpoints.28 A recent study has suggested that, during a season with good
vaccine match, vaccine effectiveness was between 60 and 85% in children
ranging in age from 6 months to <6 years.28 When vaccine match was poor,
vaccine effectiveness ranged from zero to about 60%.28 A recent systematic
review estimated the overall efficacy of inactivated vaccines against laboratoryconfirmed influenza in healthy adults <65 years of age to be 59%, although
4.7 INFLUENZA
All the influenza vaccines currently available in Australia are either split virion
or subunit vaccines prepared from purified inactivated influenza virus that has
been cultivated in embryonated hens eggs. Split virion and subunit vaccines
are generally considered to be equivalent with respect to safety, and both
are substantially free of the systemic reactions sometimes induced by whole
virus vaccines. One exception is Fluvax (CSL Limited), which in 2010 resulted
in higher rates of adverse events, specifically fevers and febrile convulsions,
in children aged <5 years, in comparison with other influenza vaccines (see
4.7.11 Adverse events below).17 Because influenza vaccine viruses are cultivated
in embryonated hens eggs, these vaccines may contain traces of egg-derived
proteins. Manufacturing processes vary by manufacturer, and different
chemicals (formaldehyde or -propiolactone) may be used to inactivate the
virus. The product information for each vaccine should be consulted for specific
information. (See also Vaccination of persons with a known egg allergy in 3.3.1
Vaccination of persons who have had an adverse event following immunisation.)
efficacy varied by influenza season.29 The efficacy of inactivated influenza vaccine

against influenza-like illness in persons 65 years of age living in the community
is estimated to be 43% when viral circulation is high, although there have been
few randomised controlled trials of influenza vaccine in elderly people.30 A
systematic review assessing vaccine effectiveness estimated that during periods
of high virus circulation, when vaccine match is good, influenza vaccination
is approximately 45% effective against hospitalisations due to influenza and
pneumonia and 60% effective against all-cause mortality in persons aged >65
years in nursing home settings.30
Currently available influenza vaccines confer protection for about a year. Low
levels of protection may persist for a further year, if the prevalent strain remains
the same or undergoes only minor antigenic drift.13,27 Continuing protection
requires annual vaccination with vaccine containing the most recent strains.

At the end of each year, influenza vaccines should be appropriately discarded
to avoid inadvertently using a product with incorrect formulation in the
following year.

Vaccines registered by the TGA, and the ages for which they are indicated,
can change from year to year. Always check annual seasonal influenza vaccine
availability statements on www.immunise.health.gov.au, and consult individual
product information.
Influenza vaccines available in Australia for IM use are presented in pre-filled
syringes, of either 0.5mL or 0.25mL. The dose of vaccine to be administered
varies by age, with children aged 6 months to <3 years requiring a 0.25mL dose.
See Table 4.7.1 for the recommended doses of influenza vaccine for different
age groups. Some 0.5mL syringes have a graduated mark to indicate where the
plunger can be depressed to provide a 0.25mL dose, if indicated.
Shake the pre-filled syringe vigorously before injection. Most influenza vaccines
should be given by IM injection. However, if administered by SC injection, the
vaccine does not need to be re-administered. The IM route causes fewer local
reactions and is preferred over the SC route.32
Intradermal influenza vaccines are presented in a purpose-designed syringe
containing 0.1mL of vaccine, the Micro-Injection System, and do not require
mixing before administration. They should be administered according to
manufacturers instructions.
Table 4.7.1: Recommended doses of influenza vaccine

Age
Number of doses (first Number of doses*

year of vaccination)
(subsequent years)
0.25 mL
2
1
0.5 mL
2
1
0.5 mL
1
1
* If a child 6 months to 9 years of age receiving influenza vaccine for the first time inadvertently
does not receive the 2nd dose within the same year, he/she should have 2 doses administered the
following year.33-35
Two doses, at least 4 weeks apart, are recommended for children aged 9 years who are receiving
influenza vaccine for the first time. The same vial should not be re-used for the 2 doses.31
Two doses, at least 4 weeks apart, are recommended for immunocompromised persons receiving
influenza vaccine for the first time (see 3.3 Groups with special vaccination requirements). The same
vial should not be re-used for the 2 doses.
Vaccination is best undertaken in autumn, in anticipation of winter outbreaks of

influenza. However, vaccination can be given as early as February if vaccine is
available, particularly for the northern areas of Queensland and in the Northern
Territory where the seasonality of influenza differs from the southern states.
In autumn, the opportunities to provide influenza vaccination to persons
at increased risk of influenza should not be missed during visits for routine
medical care.
As full protection is usually achieved within 10 to 14 days and there is
evidence of increased immunity within a few days, vaccination can still
be offered to adults and children after influenza virus activity has been
documented in the community.

Influenza vaccine can be administered concurrently with other vaccines,
including pneumococcal polysaccharide vaccine and all scheduled childhood
vaccines. However, parents/carers of infants or children who are recommended
to receive both influenza vaccine and 13-valent pneumococcal conjugate
vaccine (13vPCV) should be advised of the increased risk of fever following
concomitant administration of these vaccines (see 4.7.10 Precautions below and
4.13 Pneumococcal disease).
Annual influenza vaccination is recommended for any person 6 months
of age for whom it is desired to reduce the likelihood of becoming ill with
influenza.5,6,36,37
Influenza vaccination is strongly recommended and should be actively promoted
for the groups discussed below.
4.7 INFLUENZA
6 months to <3 years

3 to 9 years
10 years
Dose
All adults aged 65 years

There is evidence that influenza vaccine reduces hospitalisations from influenza
and pneumonia and all-cause mortality in adults 65 years of age.30 (See also
4.7.4 Vaccines above.)
Persons at increased risk of complications from influenza infection

Persons aged 6 months with conditions predisposing to severe influenza,7
such as:
Pregnancy Pregnant women (and women planning pregnancy) are
recommended to be immunised against influenza because they are at
increased risk of morbidity and mortality from influenza and because
there is good evidence that influenza immunisation in pregnancy is safe
and effective.38-45 The risk to the mother of complications from influenza
increases in the later stages of pregnancy.38-42,46-50 There is also a growing
body of evidence showing that influenza vaccination of pregnant women
protects infants against influenza for the first 6 months after birth.39,51,52 Most
evidence around infant protection is from studies of maternal influenza
vaccination in the second or third trimester.38-42,46-51 Influenza vaccination is
thought to provide protection for up to a year, but there is limited evidence
that immunity may start to wane from 4 months following immunisation.
Although it is recommended that all pregnant women should be immunised
as early as possible in pregnancy,53 the precise timing of vaccination will
depend on the time of the year, vaccine availability, influenza seasonality,
gestation of pregnancy and the likely duration of immunity. (See also 4.7.8
Pregnancy and breastfeeding below.)
Cardiac disease, including cyanotic congenital heart disease, coronary artery
disease and congestive heart failure Influenza causes increased morbidity
and mortality in children with congenital heart disease and adults with
coronary artery disease and congestive heart failure.37,54-57
Down syndrome Persons with Down syndrome should receive annual
seasonal influenza vaccine whether or not they have congenital heart
disease. This is due to the presence of anatomical abnormalities, which put
them at increased risk of upper respiratory tract infections, as well as a high
prevalence of other medical conditions that put them at increased risk of
severe influenza.56
Obesity Persons with significant obesity, defined as a BMI 30kg/m2, with
or without other underlying conditions, have been identified as being at
increased risk for hospitalisation with respiratory complications following
influenza.37 This risk was particularly apparent during the 20092010
pandemic.58,59
Chronic respiratory conditions, including:
Chronic obstructive pulmonary disease (COPD) and chronic

emphysema37,61,62 Data from several studies provide evidence that
influenza vaccination has a clinically important protective effect on
influenza-related COPD exacerbations, and probably an effect on the total
number of exacerbations in COPD patients.61,62
Severe asthma In patients with severe asthma, defined as requiring
frequent hospital visits and the use of multiple medications, annual
influenza vaccine is an important part of routine care.37,55 There are
insufficient data from randomised controlled trials of influenza vaccine
to define efficacy across the whole spectrum of asthma, but influenza can
cause severe exacerbations of wheezing, and about 10% of episodes of
virus-induced wheezing are attributable to influenza.
Chronic neurological conditions (e.g. multiple sclerosis, spinal cord injuries,
seizure disorders or other neuromuscular disorders) These conditions
can compromise respiratory function or the expulsion of respiratory
secretions that can then increase the risk for aspiration.37,55 Influenza
vaccination is particularly important for children 6 months of age with
chronic neurological conditions as these children can experience severe,
even fatal, influenza.
Immunocompromising conditions Persons who are immunocompromised,
including those with HIV infection, malignancy or chronic steroid
use, are at an increased risk from influenza (see 3.3,3 Vaccination of
immunocompromised persons).37,55 They may also have a reduced immune
response to the vaccine, although influenza vaccination affords some
protection.63 Influenza vaccination is recommended annually in all oncology
patients aged 6 months.


vaccine for the first time, are recommended to receive 2 vaccine doses, at
least 4 weeks apart, and 1 dose annually thereafter. Where it is known that
a new influenza vaccine strain is circulating in the community to which
cross-protective immunity in the population is low (such as in the setting of
an influenza pandemic), it may be appropriate that immunocompromised
persons receive 2 doses of inactivated influenza vaccine, a minimum of
4 weeks apart, to achieve an optimal immune response. For example,
in the 20092010 H1N1 global influenza pandemic it was shown that
seroconversion to influenza vaccination in immunocompromised adolescents
and adults was improved following receipt of 2 vaccine doses.64 Further
4.7 INFLUENZA
Suppurative lung disease, bronchiectasis and cystic fibrosis37,55 Patients

with these diseases are at greatly increased risk from influenza, which may
cause irreversible deterioration in lung function.60
information and annual influenza vaccine recommendations are available on

the Immunise Australia website (www.imunise.health.gov.au).

While patients with advanced HIV disease and low CD4+ T-lymphocyte
counts may not develop protective antibody titres, there is evidence that
for those with minimal symptoms and high CD4+ T-lymphocyte counts,
protective antibody titres are obtained after influenza vaccination. Influenza
vaccine has been shown to reduce the incidence of influenza in HIVinfected patients, and, although viral load may increase transiently, there
was no impact on CD4+ count.63 (See also 3.3 Groups with special vaccination
requirements, Table 3.3.4.)
Other chronic illnesses requiring regular medical follow-up or hospitalisation

in the preceding year, including:
diabetes mellitus37,55,65
chronic renal failure37,55
alcoholism66,67
haemoglobinopathies55
chronic inherited metabolic diseases (which includes amino acid disorders,
carbohydrate disorders, cholesterol biosynthesis disorders, fatty acid
oxidation defects, lactic acidosis, mitochondrial disorders, organic acid
disorders, urea cycle disorders, vitamin/cofactor disorders, porphyrias)37,55
Long-term aspirin therapy in children (aged 6 months to 10 years) Such
children are at increased risk of Reye syndrome after influenza.68,69
Aboriginal and Torres Strait Islander people aged 15 years

Annual influenza vaccination is recommended for all Aboriginal and Torres
Strait Islander people 15 years of age, in view of their substantially increased
risk of hospitalisation and death from influenza and pneumonia.70 (See also 3.1
Vaccination for Aboriginal and Torres Strait Islander people and 4.13 Pneumococcal
disease.)
Children aged <5 years

Young infants and children aged <5 years, particularly Aboriginal and Torres
Strait Islander children, are at increased risk for hospitalisation and increased
morbidity and mortality following influenza71-73(see Figure 4.7.1). While many
children who have a medical condition are at risk of increased morbidity and
mortality following influenza, children without pre-existing medical conditions,
particularly those aged <2 years, have also been found to be at increased risk for
hospitalisation compared with older children and adults.71,72,74 Vaccines can be
used in children from 6 months of age. Specific brands are registered by the TGA
for use in children and these may change from year to year (see 4.7.6 Dosage and
administration above).
Residents of residential aged care facilities and long-term residential facilities
Homeless people
The living conditions and prevalence of underlying medical conditions among
homeless people will predispose them to complications and transmission of
influenza.
Persons who may transmit influenza to persons at increased risk of

complications from influenza infection
The following groups of people can potentially transmit influenza to persons
at increased risk of complications from influenza infection; vaccination of these
groups is therefore recommended to protect those at risk:
all healthcare providers (particularly those of immunocompromised patients)
staff (or volunteers) working in nursing homes
staff (or volunteers) working in long-term care facilities
household contacts (including children 6 months of age) of those in highrisk groups, including providers of home care to persons at risk of high
influenza morbidity
staff working in early childhood education and care
staff (or volunteers) providing care to homeless people.
Persons involved in the commercial poultry or pork industry or in culling

poultry or pigs during confirmed avian or swine influenza activity
Vaccination using the seasonal influenza vaccine composition current at the
time is recommended for poultry or piggery workers and others in regular close
contact with poultry or pigs during an avian or swine influenza outbreak.75
Although routine seasonal influenza vaccine does not protect against avian or
swine influenza, there is a possibility that a person who is infected at the same
time with animal and human strains of influenza virus could act as a vessel for
reassortment of the two strains to form a virulent strain, with the potential for
spread from human to human (i.e. initiate a pandemic as was the case with swine
influenza in 2009).76 In addition, vaccination can also prevent the transmission of
influenza from humans to animals.
Persons providing essential services

Vaccination of those who provide essential community services will minimise
disruption of essential activities during influenza outbreaks. Influenza viral
infections can place considerable pressure upon both public and private
healthcare services (see 3.3 Groups with special vaccination requirements, Table
3.3.7 Recommended vaccinations for persons at increased risk of certain occupationally
acquired vaccine-preventable diseases).
4.7 INFLUENZA
Annual influenza vaccination is recommended for residents of these facilities,

including inmates of correctional facilities, due to high rates of influenza
transmission and complications during outbreaks in such facilities.12,13,62
Workers in other industries

Due to the high attack rate of influenza in the general population, influenza
vaccination in the workplace can result in benefits such as increased productivity
and reduced absenteeism among workers.77 Employers should consider the
benefits of offering influenza vaccine in their individual workplace.
Travellers
Influenza vaccine is particularly relevant if influenza epidemics are occurring at
the travellers destination(s). Travellers in large tourist groups, especially those
including older people, those travelling on cruises, and/or those who are likely
to be in confined circumstances for days to weeks, are at risk of influenza, either
acquired before departure or from travel to areas of the world where influenza
is currently circulating. Influenza vaccination is recommended if travelling
during the influenza season, especially if it is known before travel that influenza
is circulating in the destination region.78 (See also 3.2 Vaccination for international
travel.)

Influenza vaccination is recommended for pregnant women (see 4.7.7
Recommendations above) and is safe to administer during any stage of pregnancy
or while breastfeeding.44,79-81
The only absolute contraindications to influenza vaccines are:
anaphylaxis following a previous dose of any influenza vaccine
See 4.7.10 Precautions below for persons with a known egg allergy.
4.7.10 Precautions
Persons with known egg allergy82-86
Several recently published reviews, guidelines and reports have indicated that
the risk of anaphylaxis associated with influenza vaccination of egg-allergic
patients is very low.82-86 Persons with egg allergy, including anaphylaxis, can be
safely vaccinated with influenza vaccines that have less than 1g of residual egg
ovalbumin per dose.82,84 Due to changes in influenza vaccine manufacturing, the
majority of influenza vaccines currently used contain less than 1g of ovalbumin
per dose.82 Note the amount of residual egg ovalbumin may vary from year to
year due to manufacturing processes, batches and country of origin.82,84,85 The
product information (PI) of the vaccine to be given should be checked for the
vaccines ovalbumin content prior to vaccine administration. Allergy testing with
influenza vaccine prior to administration is not recommended as there is poor

correlation between test results and vaccine tolerance.82,84-86
Persons with a history of Guillain-Barr syndrome

Persons with a history of Guillain-Barr syndrome (GBS) have an increased
likelihood in general of developing GBS again, and the chance of them
coincidentally developing the syndrome following influenza vaccination may be
higher than in persons with no history of GBS.87 Diagnosis of GBS is complex and
must be made by a physician. (See also 4.7.11 Adverse events below.)
Children requiring both influenza and 13-valent pneumococcal

conjugate vaccine
Parents/carers of infants or children who are recommended to receive both
influenza vaccine and 13vPCV should be advised of the slightly higher risk
of fever following concomitant administration of these vaccines (see 4.13
Pneumococcal disease). Given this relatively low increase in risk, providing
13vPCV and inactivated trivalent influenza vaccine concurrently to children aged
1223 months is acceptable; however, immunisation service providers should
advise parents regarding this, and provide the option of administering these two
vaccines on separate days (with an interval of not less than 3 days). In the event
that fever occurs following either vaccine, an interval may minimise the risk of
increased adverse reactions.

Fever, malaise and myalgia occur commonly, in 1 to 10% of persons who receive
influenza vaccination.88-90 These adverse events may commence within a few
hours of vaccination and may last for 1 to 2 days.88-90 In children <5 years of age,
these side effects may be more pronounced. In 2010, an excess of fever and febrile
convulsions following influenza vaccination was reported in children aged
<5 years, particularly children aged <3 years. This was associated only with
one manufacturers vaccine (Fluvax and Fluvax Junior, CSL Limited); following
vaccination with this vaccine, febrile convulsions occurred at a rate of 4.4 per
1000 doses in children <5 years of age.91 This vaccine is no longer registered for
use in children aged <5 years and is not recommended for administration in
children aged <10 years (see 4.7.4 Vaccines above).92
Local adverse events (induration, swelling, redness and pain) occur in more than
10% of vaccine recipients, following IM influenza vaccine administration.89,90
4.7 INFLUENZA
However, there is still a low risk of anaphylaxis, so it is essential that such

patients are vaccinated in facilities with staff able to recognise and treat
anaphylaxis. Additional information on influenza vaccination of individuals
with an allergy to eggs, including risk, dosage and observation period, can be
found in the Australasian Society of Clinical Immunology and Allergy (ASCIA)
guidelines.84 (See also Vaccination of persons with a known egg allergy in 3.3.1
Vaccination of persons who have had an adverse event following immunisation.)
Local adverse events (induration, redness, swelling and pruritus) occur more
commonly following intradermal influenza vaccine administration. However,
most patients report that these events are transient and resolve fully within a
few days.93
Post-vaccination symptoms may mimic influenza infection, but all currently
available influenza vaccines do not contain live virus and so do not cause
influenza.
Immediate adverse events (such as hives, angioedema or anaphylaxis) are a
rare consequence of influenza vaccination. They probably represent an allergic
response to a residual component of the manufacturing process, most likely egg
protein.82,84 Persons with a history of anaphylaxis after eating eggs or a history
of a severe allergic reaction following occupational exposure to egg protein may
receive influenza vaccination after medical consultation.82,84
A small increased risk of GBS was associated historically with one influenza
vaccine in the United States in 1976, but, since then, close surveillance has shown
that GBS has occurred at a very low rate of up to 1 in 1 million doses of influenza
vaccine, if at all.94 Diagnosis of GBS is complex and must be made by a physician
(see Uncommon/rare AEFI in 2.3.2 Adverse events following immunisation).
Narcolepsy (sudden sleeping illness) has been described predominantly in the
Scandinavian population, in association with adjuvanted pandemic influenza
vaccines.95,96 These vaccines were not used and are not available in Australia.
4.7.12 Public health management of influenza

Laboratory-confirmed cases of influenza are notifiable in all states and territories
in Australia. Detailed information regarding the management of influenza cases
and contacts can be found in the national guidelines for control of influenza97
(www.health.gov.au/cdnasongs).
Further instructions about the public health management of influenza can also

The product information for influenza vaccines lists allergy to eggs, chicken
feathers and/or some food proteins as a contraindication. The ATAGI
recommends instead that patients with egg allergies and other allergies can
be vaccinated under strict medical supervision, in accordance with ASCIA
guidelines.84
The product information for Fluvax (CSL Limited) states that this vaccine is
registered for use in children 5 years of age. However, the ATAGI does not
recommend the use of this vaccine in children aged <10 years.
References
4.8.1 Virology
Japanese encephalitis (JE) is caused by a mosquito-borne RNA flavivirus.

The disease is typically an acute neurological illness, characterised by headache,
fever, convulsions, focal neurological signs and depressed level of consciousness.
It has a high case-fatality rate and there is a high prevalence of neurological
sequelae (up to 50%) in those who survive the acute illness.1 Less commonly, the
disease may present as an acute flaccid paralysis.1 Milder forms include febrile
illness with headache, and aseptic meningitis. It is recognised, however, that
most infections are asymptomatic; published estimates of the symptomatic to
asymptomatic infection ratio vary in different populations from 1:25 to 1:1000.1
4.8.3 Epidemiology
JE is a significant public health problem in many parts of Asia, including the
Indian subcontinent, Southeast Asia and China.1 In recent years, however, the
disease has extended beyond its traditionally recognised boundaries with, for
example, occasional cases in eastern Indonesia, occasional outbreaks in the
Torres Strait and 1 case in north Queensland.2,3 JE is now considered endemic
in the Torres Strait region and Papua New Guinea.2-5 The first ever outbreak of
Japanese encephalitis (JE) in Australia occurred in the remote outer islands of the
Torres Strait in 1995, with 3 cases, 2 of them fatal. There have been 5 cases to date
acquired in Australia. JE virus has only been detected infrequently in sentinel
animal surveillance in the outer islands. The sentinel pig surveillance system
has been gradually disbanded since 2006, with surveillance of the last remaining
herd on Cape York ceasing from the 20112012 wet season.
There has not been a case of JE in the Torres Strait since 1998 and the risk of
JE has diminished considerably in the outer islands since the mid-1990s. Most
communities have relocated pigs well away from homes, and major drainage
works on most islands have markedly reduced potential breeding sites for vector
mosquitoes. Between 2001 and April 2012, only 4 cases of JE virus infection were
notified in Australia.6
The JE virus is essentially a zoonosis of pigs and wading birds, and is transmitted
between these animals by culicine mosquitoes.1 The virus replicates, leading to a
transient high-level viraemia, within these so-called amplifying hosts, but not
within other large vertebrates such as horses and humans.
Indeed, humans are an incidental host, infected when living in close proximity
to the enzootic cycle; this usually occurs in rural areas where there is prolific
breeding of the vectors in flooded rice fields.1
There are two recognised epidemiological patterns of JE.1 In the temperate or
subtropical regions of Asia (northern Thailand, northern Vietnam, Korea, Japan,
4.8 JAPANESE ENCEPHALITIS
Taiwan, China, Nepal and northern India), the disease occurs in epidemics
during the summer or wet season months (April to May until September to
October). In the tropical regions (most of Southeast Asia, Sri Lanka, southern
India), the disease is endemic, occurring throughout the year, but particularly
during the wet season.1 A 2006 study confirmed that JE virus is hyperendemic in
Bali, that it causes substantial human illness, and that it circulates year round.7
In some countries (Japan, Taiwan, South Korea and some provinces of China),
the incidence of JE has declined considerably in recent decades, and it has been
eradicated from Singapore. Immunisation, changes in pig husbandry, a reduction
in land utilised for rice farming, and improved socioeconomic circumstances
have all contributed to these changes.1 Updated information regarding JE virus
activity and/or risk in travel destinations should be sought from a reputable
source prior to travel.8
4.8.4 Vaccines
Imojev Sanofi Pasteur Pty Ltd (live attenuated Japanese encephalitis
virus). Lyophilised powder in a monodose vial with separate diluent.
Each 0.5mL reconstituted dose contains 4.05.8 log plaque-forming
units (PFU) of live attenuated Japanese encephalitis virus; mannitol;
lactose; glutamic acid; potassium hydroxide; histidine; human serum
albumin. No adjuvants or antibiotics are added.
JEspect Intercell Biomedical Ltd/CSL Limited (inactivated Japanese
encephalitis virus). Each 0.5mL pre-filled syringe contains 6g of
purified inactivated Japanese encephalitis virus; 0.25mg aluminium
as aluminium hydroxide. No preservatives or antibiotics are added.
Two JE vaccines, each with different characteristics, are available for use
in Australia. The inactivated mouse brain-derived JE vaccine formulation
manufactured in Japan, JE-Vax, which was previously used in Australia, is no
longer manufactured. Clinical and animal studies have provided evidence in
support of an immunological correlate of immunity (established by the World
Health Organization as a neutralising antibody titre of 1:10). Both currently
available JE vaccines were registered on the basis of this serological correlate in
lieu of a field efficacy trial.
Imojev is a live attenuated, monovalent viral vaccine produced using
recombinant technology. Two genes of the 17D-204 yellow fever vaccine virus
have been replaced with two genes, prM and E genes, from the Japanese
encephalitis virus strain SA 14-14-2. About 94% of healthy adults aged
1884 years seroconverted to a strain homologous to that in the Imojev vaccine
14 days after a single vaccine dose.9 Several clinical trials have demonstrated that,
28 days following vaccination with a single dose of Imojev, protective levels of
Among children aged 25 years previously vaccinated with a mouse brainderived JE vaccine (of whom 86% were seropositive against the vaccine strain
and 72 to 81% seropositive against four wild-type strains at baseline), a dose
of Imojev produced seroprotective antibody levels against the vaccine strain
in 100%, and against all wild-type strains in 99%. Ninety-three per cent of the
children seroconverted to the vaccine strain and 90% against all wild-type
strains.10
JEspect is a Vero cell-derived, inactivated, aluminium-adjuvanted vaccine
based on the attenuated SA 14-14-2 JE virus strain. JEspect has equivalent
immunogenicity (after 2 doses, given 4 weeks apart) to 3 doses of the previously
available mouse brain-derived vaccine, with seroconversion achieved in 98% of
subjects.14 Post-vaccination geometric mean titres (GMT) in JEspect recipients
were significantly higher than GMTs attained after a mouse brain-derived
vaccine.14 After a standard 2-dose course, protective levels of neutralising
antibodies have been found to persist for 6 months in 95%, for 12 months in 83%
and for 24 months in 48% of JEspect-vaccinated subjects in central Europe,15,16
but in 83%, 58% and 48%, respectively, at these three time points in subjects
in western and northern Europe.17 A suggested plausible explanation for the
discrepancy between these two studies is prior vaccination with the tick-borne
encephalitis vaccine in a large proportion of subjects in the central European
study.16,17 In an extension of the western and northern European study, those who
did not have a seroprotective antibody level at either the 6- or 12-month followup point were given a booster dose at 11 and/or 23 months after first vaccination;
seropositivity was attained in 100% of these subjects.17 Another study showed
that a booster dose given 15 months after the primary immunisation with 2
doses of JEspect increased the GMT by 5-fold after 4 weeks, and the proportion
of subjects with seroprotective antibody levels increased from 69.2% pre booster
to 98.5% at 6 and 12 months post booster. Mathematical modelling has predicted
that 95% of subjects would maintain seroprotective antibodies for 3.8 years after
a booster dose.18
neutralising antibodies against the homologous vaccine virus strain are present
in 96% of vaccine-nave children aged 1224 months10 and 99% of adults.9-12
Immunogenicity was non-inferior to that attained after a 3-dose primary course
of the inactivated mouse brain-derived JE vaccine9 that was previously used in
Australia. Subjects also seroconverted to various wild-type, non-homologous,
JE virus strains (70 to 97% of children aged 1224 months and 70 to 100% of
adults);10,13 85% of adults developed neutralising antibodies against all four
wild-type strains used for testing.12 Protective antibody to the vaccine strain was
maintained at 6 months after vaccination in 87% of children aged 1224 months,10
and 97% of adults.12 About 93% of adults maintained a protective antibody level
to the vaccine strain, and 65% to at least three wild-type strains, 60 months after
a single vaccine dose.12 Establishment of immunological memory in vaccinated
adult subjects has also been demonstrated.13
A phase II study in 60 Indian children aged 1 to <3 years showed that the vaccine
JEspect was safe and immunogenic in this age group.19 Interim preliminary data
from a phase III paediatric study involving 51 children from non-JE endemic
countries aged 2 months to <18 years (mean age 12.5 years) suggested that 100%
seroconverted to protective levels, and all 18 of those who had had 7 months
follow-up from the initial dose maintained protective antibody.20
A small study among healthy military personnel observed that the immune
response after 4 weeks to 1 dose of JEspect, among those who had previously
received at least 3 doses of mouse brain-derived JE vaccine, was non-inferior to
the response after 2 doses of JEspect in those who were nave to JE vaccines.21
A small study among travellers who had received at least 2 doses of a mouse
brain-derived JE vaccine 1 to 21 years previously observed that, 4 to 8 weeks after
a single dose of JEspect, a high proportion attained protective antibody levels
against both homologous and heterologous strains (98% and 95%, respectively),
and these proportions were non-inferior compared to those who received a
booster of mouse brain-derived JE vaccine.22 The duration of antibody response
following a single dose of JEspect among those who were primed with mouse
brain-derived JE vaccine is currently unknown.

Imojev must be reconstituted by adding the entire contents of the diluent container
vaccine must be used within 1 hour.

Imojev is registered for use in persons aged 12 months in a single dose.
The dose of Imojev for both children (aged 12 months) and adults is 0.5mL, to
be given by SC injection. For individuals aged between 12 and 24 months, the
preferred injection site is the anterolateral thigh. For individuals aged >2 years,
the deltoid is the recommended injection site.
JEspect is registered for use in individuals aged 18 years. However, JEspect
can be administered to persons aged 12 months in circumstances where an
alternative is not available or contraindicated.
JEspect should be given by IM injection into the deltoid. When using JEspect in
children aged 12 months and <3 years, primary vaccination consists of 2 doses,
each of 0.25mL, according to the following schedule:
1st dose at day 0
2nd dose 28 days after the 1st dose.
1st dose at day 0

2nd dose 28 days after the 1st dose.
Do not mix either Japanese encephalitis vaccine with any other vaccine in the
same syringe.

Imojev can be given at the same time as the yellow fever vaccine,24 using
separate syringes and separate injection sites.
Co-administration with other vaccines (including other live vaccines) has not
been assessed. If Imojev and the yellow fever vaccine or other live vaccines are
not given simultaneously, they should be given at least 4 weeks apart.
JEspect can be co-administered with the hepatitis A vaccine.25 Co-administration
with other flavivirus vaccines (including yellow fever vaccine) has not been
assessed.
If co-administration of either JE vaccine with other vaccines is indicated,
injections should be given in separate limbs.
The two available JE vaccines are registered for different age groups, and have
different vaccination schedules, booster dose requirements, and contraindications
for use. These factors should be taken into account when deciding the most
appropriate vaccine to use.
The dose of Imojev should be administered at least 14 days prior to potential JE
virus exposure.
The JEspect vaccine (2-dose) schedule should be completed at least 1 week prior
to potential JE virus exposure.
Travellers
JE vaccination is recommended for:
travellers (12 months of age) spending 1 month or more in rural areas of
high-risk countries in Asia and Papua New Guinea (see 4.8.3 Epidemiology
above); however, as JE has occurred in travellers after shorter periods of
travel, JE vaccination should be considered for shorter-term travellers,
particularly if the travel is during the wet season, or anticipated to be
repeated, and/or there is considerable outdoor activity, and/or the
accommodation is not mosquito-proof26
all other travellers spending a year or more in Asia (except Singapore), even
if much of the stay is in urban areas.
When using JEspect in children aged 3 years and adults, primary vaccination
consists of 2 doses, each of 0.5mL, according to the following schedule:
All travellers to Asia (and other tropical regions) must be fully aware of the need
to take appropriate measures to avoid mosquito bites.
The risk of JE to travellers to Asia is determined by the season of travel, the
regions visited, the duration of travel, the extent of outdoor activity and the
extent to which mosquito avoidance measures are taken.1 Clearly the risk is
greater during prolonged travel to rural areas of Asia during the wet season; it is
probably negligible during short business trips to urban areas.
Torres Strait Islands

JE vaccination is recommended for:
all residents (12 months of age) of the outer islands in the Torres Strait
all non-residents (12 months of age) who will be living or working on the
outer islands of the Torres Strait for a cumulative total of 30 days or more
during the wet season (December to May).
Note: The period of greatest risk is from February to March and the vaccination
course should be completed before February. Those arriving in the outer islands
late in the wet season (i.e. in May) will arrive after the risk period and do not
require vaccination. Those visiting the outer islands in the dry season (June to
November) do not require vaccination. Those visiting only the inner islands,
including Thursday Island, do not require vaccination.
Laboratory personnel
JE vaccination is recommended for all research laboratory personnel who will
potentially be exposed to the virus.
Booster doses
Currently there is limited evidence available to inform recommendations
regarding the need and appropriate time interval for a booster dose of either
Imojev or JEspect.
A booster dose of Imojev is not currently recommended. Preliminary data from
a subset of participants in a phase II randomised controlled trial demonstrated
considerable persistence of seroprotective antibody levels 60 months following a
single dose of Imojev12 (see 4.8.4 Vaccines above).
Some data suggest that if the primary series of JEspect was administered >1 year
previously, and there is an ongoing or high risk of JE virus exposure, a booster
dose should be offered.16
For individuals previously vaccinated with the mouse brain-derived JE vaccine,
either Imojev or JEspect can be used for revaccination if there is an ongoing risk
of JE virus exposure.

Imojev is a live attenuated viral vaccine and is contraindicated in pregnant
women. Pregnancy should be avoided for 28 days after vaccination.
JEspect vaccine is not routinely recommended for pregnant or breastfeeding

women. However, as JE virus infection during the first and second trimesters
has been associated with miscarriage, pregnant women at risk of acquiring JE
should be offered JE vaccination. Although this inactivated JE vaccine might pose
a theoretical risk to the developing fetus, no adverse outcomes of pregnancy have
been attributed to vaccination against JE.
No specific data are available regarding the administration of JEspect to
breastfeeding women. Breastfeeding women who are at increased risk of
acquiring JE should be offered JE vaccination.
JE vaccines are contraindicated in persons who have had:
anaphylaxis following a previous dose of any JE vaccine
Imojev is a live attenuated viral vaccine and must not be administered to
pregnant or breastfeeding women or to any person who is immunocompromised
due to either disease and/or medical treatment.
4.8.10 Precautions
JE vaccines should not be administered during an acute febrile illness.
There are few data on the safety and efficacy of JEspect vaccine in persons who
are immunocompromised. Such persons may not mount an adequate immune
response, but, as JEspect is an inactivated vaccine, safety and reactogenicity are
not expected to be of concern in those who are immunocompromised.

Local reactions and minor systemic reactions are common to very common
following vaccination against JE.
In adults, adverse events following Imojev were similar to those in placebo
recipients,9,12 but occurred less often than in recipients of the mouse brainderived JE vaccine.9 The most common adverse events in two key studies were
injection site pain, headache, fatigue and malaise; most symptoms resolved
within 3 days.9 Similarly, in children aged 1224 months, the frequency of
adverse events after Imojev was comparable to that after the hepatitis A vaccine.
About 40% of these subjects reported injection site reactions, including pain
(32%), erythema (23%) and swelling (9%), and about 50% reported at least
one systemic reaction, including fever (21%), appetite loss (26%), irritability
(28%) and abnormal crying (23%). Frequencies of adverse events in children
There are no data on whether the Imojev vaccine virus is excreted in breast milk;
the vaccine should not be given to breastfeeding women.
aged 25 years who received Imojev after having been previously vaccinated
with the mouse brain-derived vaccine were similar to, or lower than, those
seen in children aged 1224 months not previously vaccinated. All reactions
were transient and almost all were mild. Most systemic reactions were mild or
moderate, appeared within 7 days of vaccination, and lasted up to 3 days.10
In a pooled analysis of over 4000 healthy adults who received at least 1 dose
of JEspect, 54% reported injection site reactions, most commonly pain (33%),
tenderness (33%) and redness (9%).27 Headache and myalgia were the most
commonly reported systemic adverse events.17,19,27-29 An earlier analysis found a
comparable rate of adverse events in those who received JEspect compared with
aluminium-containing placebo.28 Post-marketing surveillance reported adverse
events following JEspect at a rate of about 10 per 100 000 doses distributed;
no serious allergic reactions were observed during the first 12 months after
marketing approval.27 The frequencies of adverse events reported following a
booster dose were similar to those reported after a primary course.17,18
4.8.12 Public health management of Japanese encephalitis

JE virus infection is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of JE, including
management of cases of JE, should be obtained from state/territory public
government health authorities and communicable disease control)

JEspect is registered for use in persons aged 18 years. The ATAGI recommends
that JEspect can be administered to persons aged 12 months in circumstances
where an alternative is not available or contraindicated. The ATAGI also
recommends that children aged 12 months to <3 years receive 0.25mL doses of
JEspect.
References
4.9 MEASLES
4.9.1 Virology

Measles is a highly infectious, acute viral illness spread by respiratory
secretions, including aerosol transmission.1 It is infectious from the beginning
of the prodromal period and for up to 4 days after the appearance of the rash.
The incubation period is usually 10 to 14 days. The prodrome, lasting 2 to 4
days, is characterised by fever and malaise, followed by a cough, coryza and
conjunctivitis. The maculopapular rash typically begins on the face and upper
neck, and then becomes generalised.
Measles is often a severe disease, frequently complicated by otitis media (in
approximately 9%), pneumonia (in approximately 6%) and diarrhoea (in
approximately 8%).1,2 Acute encephalitis occurs in 1 per 1000 cases, and has
a mortality rate of 10 to 15%, with a high proportion of survivors suffering
permanent brain damage.3 Subacute sclerosing panencephalitis (SSPE) is a
late complication of measles, occurring on average 7 years after infection in
approximately 0.5 to 1 per 100 000 measles cases.1 SSPE causes progressive brain
damage and is always fatal. Complications from measles are more common and
more severe in the chronically ill, in children <5 years of age, and in adults.2
Approximately 60% of deaths from measles are attributed to pneumonia,
especially in the young, while complications from encephalitis are more
frequently seen in adults.1,2 Measles infection during pregnancy can result in
miscarriage and premature delivery, but has not been associated with congenital
malformation.2 There is no specific therapy for acute measles infection.
4.9.3 Epidemiology
Evidence suggests that endemic measles has been eliminated from Australia,
with the absence of a circulating endemic measles strain for several years.4
However, measles cases in Australia continue to occur, particularly in
returning non-immune travellers and their contacts, with measles outbreaks
of limited size and duration following importation.4 In 2005 and 2007, measles
notifications and hospitalisations were the lowest recorded in Australia.5-7
However, there has been a recent increase in imported measles cases in Australia
and subsequent outbreaks,8 highlighting the importance of continued high
2-dose vaccine coverage. High-level vaccination coverage is imperative to
maintain measles elimination, with rates for each new birth cohort of >95%
4.9 MEASLES
Measles is a paramyxovirus, genus Morbillivirus. It is an RNA virus with six

structural proteins, three complexed to the RNA and three associated with the
viral envelope. Two of the envelope proteins, the F (fusion) protein and the H
(haemagglutinin) protein, are the most important in pathogenesis. The measles
virus can survive for up to 2 hours in air, but is rapidly inactivated by heat, light
and extremes of pH.1,2
for a single dose and >90% for 2 doses required.9 A decline in vaccination rates
has resulted in a resurgence in endemic transmission in a number of European
countries, including the United Kingdom.10 In 2009, the Australian Childhood
Immunisation Register recorded that 94.0% of children aged 2 years had received
at least 1 dose of measles-containing vaccine and 80.3% of children aged 5 years
had received 2 doses.11
National serosurveys in early 1999 (evaluating the 1998 National Measles Control
Campaign) and in 2000 showed that those most at risk of measles infection
in Australia were infants <12 months of age, 1 to <2-year olds due to delayed
vaccine uptake, and persons born in the late 1960s to mid-1980s (especially
the 19781982 birth cohort).12-14 Young adults are recognised to be at a greater
risk of measles infection as many missed being vaccinated as infants (when
vaccine coverage was low), while during their childhood a 2nd dose was not
yet recommended and disease exposure was decreasing. They may also have
missed catch-up vaccinations during their school years as part of either the
Measles Control Campaign (which only targeted primary school-aged children)
or the Young Adult Measles Control Campaign (which did not result in high
coverage).15 A high proportion of recent measles cases in Australia have been in
unvaccinated young adults.8,16 Since the Measles Control Campaign, there have
been no deaths recorded from measles, with the last measles death recorded in
1995.5-7,17 Since 1998, 2 deaths have been attributed to SSPE in Australia, 1 in 1999
and 1 in 2004.6,18
Global elimination of measles

The World Health Organization (WHO) is overseeing efforts to eliminate
measles worldwide through immunisation and surveillance strategies.19 In
2000, measles was the fifth leading cause of childhood morbidity and mortality
worldwide. There were an estimated 770 000 deaths, with more than half of
these occurring in Africa.2,20 Following extensive vaccination campaigns, there
was a 78% reduction to 164 000 deaths worldwide in 2008, with the majority
of deaths reported in Southeast Asia.21 In 2003, measles elimination, defined as
the absence of endemic measles virus transmission, was included as a regional
goal under the Expanded Programme on Immunization (EPI) for the WHO
Western Pacific Region, with a target date set for 2012.22 Considerable progress
has been made with an 86% decline in measles cases in the region (excluding
China).22 However, achieving elimination requires continued strengthening of
immunisation and surveillance efforts, particularly identification of measles
virus genotypes to confirm the absence of an endemic strain. Globally, 10
countries have formally declared measles elimination, including Australia;4
however, consistent criteria for establishing measles elimination across WHO
regions are still being developed.23
4.9.4 Vaccines
Measles immunity induced by 1-dose vaccination provides long-term immunity

in most recipients.2,24 However, approximately 5% of recipients fail to develop
immunity to measles after 1 dose.25 Following a 2nd vaccine dose, approximately
99% of subjects overall will be immune to measles. Measles vaccine effectiveness
studies have found the measles-containing vaccines to be 90 to 95% effective in
developed country settings with high vaccination coverage and low incidence of
measles.2 A Cochrane review reported 1-dose vaccine effectiveness to be 95%;26
however, effectiveness has been demonstrated to be lower, particularly by region
(e.g. Asia, Africa) in 1-dose recipients.27
Combination MMRV vaccines have been shown in clinical trials, predominantly
conducted in children 12 months to 6 years of age, to produce similar rates
of seroconversion to all four vaccine components compared with MMR and
monovalent varicella vaccines administered concomitantly at separate injection
sites.28-31 In one comparative study assessing seroresponses to a single MMRV
vaccine dose in 1214-month-old children, the seroresponse rates to measles,
mumps and rubella were similar, but varicella seroresponses were lower in
Priorix-tetra recipients than in ProQuad recipients.32 However, the clinical
significance of this is not clear, particularly for MMRV given after MMR vaccine.32
Information on adverse events related to MMR and MMRV vaccines is provided
in 4.9.11 Adverse events below, and also in 4.22 Varicella (for MMRV).
Trivalent measles-mumps-rubella (MMR) vaccines

M-M-R II CSL Limited/Merck & Co Inc (live attenuated measles
virus [Enders attenuated Edmonston strain], mumps virus [Jeryl
Lynn B level strain] and rubella virus [Wistar RA 27/3 strain]).
Lyophilised pellet in a monodose vial with separate diluent. Each
0.5mL reconstituted dose contains 1000 tissue culture infectious
dose 50% (TCID50) of Enders attenuated Edmonston measles
virus, 12500 TCID50 of the Jeryl Lynn B level mumps virus, and
1000 TCID50 of the Wistar RA 27/3 rubella virus; sorbitol; sucrose;
hydrolysed gelatin; human albumin; fetal bovine serum; neomycin.
Priorix GlaxoSmithKline (live attenuated measles virus [Schwarz
strain], mumps virus [RIT 4385 strain, derived from the Jeryl Lynn
strain] and rubella virus [Wistar RA 27/3 strain]). Lyophilised pellet
4.9 MEASLES
Monovalent measles vaccine is not available in Australia. Measles vaccination

is provided using either measles-mumps-rubella (MMR) or measles-mumpsrubella-varicella (MMRV) vaccines. Two quadrivalent combination vaccines
containing live attenuated measles, mumps, rubella and varicella viruses
(MMRV) are registered in Australia.

reconstituted dose contains 103.0 cell culture infectious dose 50%
(CCID50) of the Schwarz measles virus, 103.7 CCID50 of the RIT 4385
mumps virus, and 103.0 CCID50 of the Wistar RA 27/3 rubella virus;
lactose; neomycin; sorbitol; mannitol.
Quadrivalent measles-mumps-rubella-varicella (MMRV) vaccines

Priorix-tetra GlaxoSmithKline (live attenuated measles virus
[Schwarz strain], mumps virus [RIT 4385 strain, derived from the
Jeryl Lynn strain], rubella virus [Wistar RA 27/3 strain] and varicellazoster virus [Oka strain]). Lyophilised pellet in a monodose vial with
a pre-filled diluent syringe. Each 0.5mL reconstituted dose contains
103.0 CCID50 of the Schwarz measles virus, 104.4 CCID50 of the RIT
4385 mumps virus, 103.0 CCID50 of the Wistar RA 27/3 rubella virus,
and 103.3 plaque-forming units (PFU) of Oka varicella-zoster virus;
ProQuad CSL Limited/Merck & Co Inc (live attenuated measles
Lynn B level strain], rubella virus [Wistar RA 27/3 strain] and
varicella-zoster virus [Oka/Merck strain]). Lyophilised powder
reconstituted dose contains 103.0 TCID50 of Enders attenuated
Edmonston measles virus, 104.3 TCID50 of the Jeryl Lynn B level
mumps virus, 103.0 TCID50 of the Wistar RA 27/3 rubella virus, and
103.99 PFU of Oka/Merck varicella virus; sucrose; hydrolysed gelatin;
urea; sorbitol; monosodium L-glutamate; human albumin; neomycin;
residual components of MRC-5 cells; bovine serum albumin.

Both MMR and MMRV vaccines must be reconstituted by adding the entire
contents of the diluent container to the vial containing the pellet and shaking
until the pellet is completely dissolved.
Reconstituted Priorix (MMR), M-M-R II (MMR) and Priorix-tetra (MMRV)
vaccines should be used as soon as practicable. If storage is necessary, hold at
Reconstituted ProQuad (MMRV) vaccine must be used within 30 minutes.

The dose of Priorix (MMR) vaccine for both children and adults is 0.5mL, to be
given by either SC or IM injection.
For children <14 years of age, the dose of MMRV vaccine is 0.5mL, to be given
by SC injection. Priorix-tetra may also be given by IM injection.34
MMRV vaccines are not recommended for use in persons aged 14 years.
When 2 doses of MMR-containing vaccine are required, the minimum interval
between doses is 4 weeks.

MMR or MMRV vaccines can be given at the same time as other live attenuated
parenteral vaccines (e.g. varicella, BCG, yellow fever) or other inactivated
vaccines (including DTPa, hepatitis B, Hib, IPV, MenCCV, hepatitis A and
pneumococcal conjugate vaccine),32 using separate syringes and injection sites. If
MMR or MMRV vaccine is not given simultaneously with other live attenuated
parenteral vaccines, they should be given at least 4 weeks apart.35,36
If MMR vaccine is given at the same time as monovalent varicella vaccine (VV),
they should be given using separate syringes and injection sites. MMR vaccine
and monovalent VV should not be mixed together prior to injection.
Separate administration of measles, mumps or rubella vaccine is not available
as an alternative to MMR vaccine, although a monovalent varicella vaccine is
available (see 4.22 Varicella).
Interchangeability of MMR-containing vaccines

In general, the two brands of MMR vaccine can be considered interchangeable,
that is, the 2nd MMR dose does not have to be of the same brand as the 1st. The
same principle applies to the two available MMRV vaccines,32 although they are
not routinely recommended in a 2-dose schedule.
For additional recommendations associated with MMRV administration to
prevent varicella disease, see 4.22 Varicella.
Infants aged <12 months

MMR-containing vaccines are not routinely recommended for infants
<12 months of age. However, MMR vaccine can be given to children from as
early as 9 months of age in certain circumstances, including travel to highly
endemic areas and during outbreaks (see Travellers below, and 4.9.12 Public
health management of measles).
4.9 MEASLES
The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5mL, to
be given by SC injection.
Two doses of measles-containing vaccine should be administered at 12 months

of age (see Children below). This is because maternal antibodies to measles are
known to persist in many infants until approximately 11 months of age and may
interfere with active immunisation before 12 months of age.2 However, there is
some evidence that a dose provided at 11 months (but prior to 12 months) of
age is sufficiently immunogenic; as such, doses given in this timeframe may not
need to be repeated in all circumstances (see also Table 2.1.5 Minimum acceptable
age for the 1st dose of scheduled vaccines in infants in special circumstances).
Children
Two doses of measles-containing vaccine are recommended for all children. The
1st dose should be given at 12 months of age as MMR vaccine. MMRV vaccines
are not recommended for use as the 1st dose of MMR-containing vaccine in
children <4 years of age, due to a small but increased risk of fever and febrile
seizures when given as the 1st MMR-containing vaccine dose in this age group
(see 4.9.11 Adverse events and Table 4.9.1 below).
The 2nd dose of measles-containing vaccine is recommended to be given
routinely at 18 months of age as MMRV vaccine. This is to commence from July
2013 once MMRV vaccine(s) are available under the NIP (see Table 4.9.1 below).
The recommended age for administration of the 2nd dose of measles-containing
vaccine will be moved down from 4 years of age, to provide earlier 2-dose
protection against measles, mumps and rubella, and to improve vaccine uptake
(see 4.9.3 Epidemiology above).
Catch-up vaccination of children who did not receive the 2nd dose of MMRcontaining vaccine at 18 months of age can occur at the 4-year-old schedule point,
until all relevant children have reached 4 years of age. Use of MMRV vaccine
at the 4-year-old schedule point is preferred when varicella vaccination is also
indicated (see 4.22 Varicella).
Children >12 months of age who have received 1 dose of MMR vaccine can be
offered their 2nd dose of MMR-containing vaccine early (if at least 4 weeks after
the 1st dose has elapsed) if they are considered at risk of coming in contact with
measles37 (see 4.9.12 Public health management of measles below).
If MMRV vaccine is inadvertently administered as dose 1 of MMR-containing
vaccine, the dose does not need to be repeated (providing it was given at
12 months of age; see also Table 2.1.5 Minimum acceptable age for the 1st dose of
scheduled vaccines in infants in special circumstances). However, parents/carers
should be advised regarding the small but increased risk of fever and febrile
seizures (compared with that expected following MMR vaccine).
Vaccines
Schedule point (age)

12 months
18 months
4 years
(a) O
nly monovalent varicella
vaccine available
MMR
VV
MMR*
(b) When MMRV vaccine available

(from July 2013)
MMR
MMRV
* The 2nd dose of MMR-containing vaccine is recommended to be provided at 18 months of age

to improve 2-dose coverage and protection against measles in young children. However, until
June 2013, the 2nd dose of MMR vaccine is included under the NIP schedule for administration
at 4 years of age. From July 2013, the 2nd dose of MMR vaccine will move to the 18-month NIP
schedule point and be provided as MMRV vaccine.
Adults and adolescents

Persons born before 1966
No vaccination is required for persons born before 1966 (unless serological

evidence indicates otherwise), as circulating virus and disease were prevalent
before this time, suggesting most persons would have acquired immunity
from natural infection. However, confirmed cases of measles have occurred in
persons born before 19667 and, if doubt exists, it may be more expedient to offer
vaccination than serological testing. (See also Serological testing for immunity to
measles below.)
Persons born during or since 1966
All persons born during or since 1966 who are 18 months of age (or, until
catch-up following the move of the 2nd NIP dose of measles-containing
vaccine to 18 months of age is completed, are 4 years of age) should have
documented evidence of 2 doses of MMR-containing vaccine (administered
at least 4 weeks apart and with both doses administered at 12 months of age;
see Children above) or have serological evidence of protection for measles,
mumps and rubella.
It is recommended that all adolescents and young adults have their
vaccination records reviewed to ensure they have received 2 doses of MMR
vaccine (see 4.9.3 Epidemiology above).
MMRV vaccines are not recommended for use in persons 14 years of age, due
to a lack of data on safety and immunogenicity/efficacy in this age group. If a
dose of MMRV vaccine is inadvertently given to an older person, this dose does
not need to be repeated.
4.9 MEASLES
Table 4.9.1: R
ecommendations for measles vaccination with (a) measlesmumps-rubella (MMR) (currently available), and (b) once measlesmumps-rubella-varicella (MMRV) vaccines are available from
July 2013
Healthcare workers and other occupations

All adolescents and adults (born during or since 1966) should have their
vaccination records reviewed to ensure they have received 2 doses of MMR
vaccine. This is important for all persons, but especially those working in certain
occupations, such as healthcare workers, staff working in early childhood
education and care, staff of long-term care facilities and staff of correctional
facilities. Those who were born during or since 1966 and are non-immune, or
who have only received 1 dose of MMR vaccine, should be vaccinated and have
documented evidence of 2 doses of MMR vaccine or serological evidence of
immunity to measles (see Adults and adolescents above). (See also 3.3 Groups
with special vaccination requirements, Table 3.3.7 Recommended vaccinations for
persons at increased risk of certain occupationally acquired vaccine-preventable diseases.)
Travellers
It is especially important that all persons born during or since 1966 have been
given 2 doses of measles-containing vaccine (administered at least 4 weeks
apart, with both doses administered at 12 months of age; see Children above)
before embarking on international travel if they do not have evidence of previous
receipt of 2 doses of MMR vaccine or serological evidence of protection for
measles, mumps and rubella (see Adults and adolescents above).
Infants travelling to countries in which measles is endemic, or where measles
outbreaks are occurring, may be given MMR vaccine from as young as 9 months
of age, after an individual risk assessment. In these cases, 2 further doses of
MMR vaccine are still required. The next dose of MMR vaccine should be given
at 12 months of age or 4 weeks after the 1st dose, whichever is later. This should
be followed by the routine administration of the next dose of measles-containing
vaccine, as MMRV vaccine, at 18 months of age.
Serological testing for immunity to measles

Serological testing for immunity to measles, mumps, rubella or varicella is not
recommended before or after routine administration of the 2-dose childhood
schedule of these vaccines.
However, serological testing for measles can be performed in cases where a
history of natural immunity or 2 doses of vaccine administration is uncertain
(see Adults and adolescents above). Serology is indicated in special situations,
such as pre-pregnancy planning (see also 4.18 Rubella, 4.22 Varicella and 3.3.2
Vaccination of women who are planning pregnancy, pregnant or breastfeeding, and
preterm infants). Serological tests to investigate immunity to measles are generally
sensitive at detecting antibody produced by both prior natural infection and
vaccination, although sensitivity varies by assay and the clinical setting (e.g.
time since vaccination).2 Interpretation of the results of serological testing may
be enhanced by discussion with the laboratory that performed the test, ensuring
that relevant clinical information is provided. An alternative to serological testing
is presumptive administration of MMR vaccine dose(s). There is no known
increase in adverse events from vaccinating those with pre-existing immunity to

one or more of the vaccine components (see 4.9.11 Adverse events below).
MMR vaccines can be given to breastfeeding women. (See also 4.18 Rubella.)
There is no risk to pregnant women from contact with recently vaccinated
persons. The vaccine virus is not transmitted from vaccinated persons to
susceptible contacts.1
See also 4.18 Rubella, 4.22 Varicella and 3.3 Groups with special vaccination
requirements, Table 3.3.1 Recommendations for vaccination in pregnancy for more
information.
Anaphylaxis to vaccine components
MMR and MMRV vaccines are contraindicated in persons who have had:
anaphylaxis following a previous dose of any MMR-containing vaccine

Measles-, mumps- and rubella-containing vaccines contain live
attenuated vaccine viruses and are contraindicated in persons who are
immunocompromised. Thus, MMR-containing vaccines are contraindicated in
the following groups:
Persons immunocompromised due to HIV/AIDS. MMR vaccination of
asymptomatic HIV-infected persons >12 months of age with an age-specific
CD4+ count of 15% may be considered39-42 (see HIV-infected persons
in 3.3.3 Vaccination of immunocompromised persons). Since studies have not
been performed using combination MMRV vaccines in asymptomatic HIVinfected persons or persons with an age-specific CD4+ count of 15%, it is
recommended that only MMR vaccine (and monovalent VV, see 4.22 Varicella)
be considered for use in this setting.41,43-45
Persons with other medical conditions associated with significant
immunocompromise (see 3.3.3 Vaccination of immunocompromised persons).
Persons receiving high-dose systemic immunosuppressive therapy,
such as chemotherapy, radiation therapy or oral corticosteroids. MMRcontaining vaccines are contraindicated in persons taking high-dose oral
corticosteroids for more than 1 week (in children equivalent to >2mg/kg
per day prednisolone, and in adults >60mg per day) (see 3.3.3 Vaccination
4.9 MEASLES
MMR-containing vaccines are contraindicated in pregnant women. Pregnancy

should be avoided for 28 days after vaccination.38
of immunocompromised persons). Those who have been receiving highdose systemic steroids for more than 1 week may be vaccinated with live
attenuated vaccines after corticosteroid therapy has been discontinued
for at least 1 month46 (see 4.9.10 Precautions below and 3.3.3 Vaccination of
immunocompromised persons).
See also 3.3 Groups with special vaccination requirements and 4.22 Varicella for more
information.
Pregnant women
See 4.9.8 Pregnancy and breastfeeding above.
4.9.10 Precautions
Persons with egg allergy
Children with egg allergy can be safely given MMR or MMRV vaccine.1,47 Skin
testing is not required prior to vaccine administration.1 Although measles and
mumps (but not rubella or varicella) vaccine viruses are grown in chick embryo
tissue cultures, it is now recognised that measles- and mumps-containing
vaccines contain negligible amounts of egg ovalbumin (see 4.9.13 Variations from
product information below).
Vaccination with other live attenuated parenteral vaccines

If MMR or MMRV vaccine is not given simultaneously with other live attenuated
parenteral vaccines (e.g. varicella, BCG, yellow fever), the vaccines should be
given at least 4 weeks apart.
Vaccination after immunoglobulin or blood product administration

Administration of MMR or MMRV vaccine should be delayed after
administration of immunoglobulin-containing products. After receipt of
immunoglobulin-containing blood products, the expected immune response
to measles, mumps, rubella and varicella vaccination may be impaired.25,35,48
MMR-containing vaccines should not be given for between 3 and 11 months
following the administration of immunoglobulin-containing blood products.
The interval between receipt of the blood product and vaccination depends on
the amount of immunoglobulin in each product, and is indicated in 3.3 Groups
with special vaccination requirements, Table 3.3.6 Recommended intervals between
either immunoglobulins or blood products and MMR, MMRV or varicella vaccination.35
For further information, see 3.3.4 Vaccination of recent recipients of normal human
immunoglobulin and other blood products.
Recent blood transfusion with washed red blood cells is not a contraindication to
MMR or MMRV vaccines.
MMR vaccine may be administered concomitantly with, or at any time in
relation to, anti-D immunoglobulin, but at a separate injection site. Anti-D
immunoglobulin does not interfere with the antibody response to vaccine.
Immunoglobulin or blood product administration after vaccination
Rh (D) immunoglobulin (anti-D) may be given at the same time in different sites
with separate syringes or at any time in relation to MMR vaccine, as it does not
interfere with the antibody response to the vaccine.
HIV-infected persons
MMR vaccine can be given to asymptomatic HIV-infected persons >12 months
of age with an age-specific CD4+ count of 15%49 (see 3.3 Groups with special
vaccination requirements, Table 3.3.4 Categories of immunocompromise in HIV-infected
persons, based on age-specific CD4+ counts and percentage of total lymphocytes). This is
because the risk posed by measles infection is considered to be greater than the
likelihood of adverse events from vaccination.46 MMR vaccine is contraindicated
in immunocompromised HIV-infected persons (see 4.9.9 Contraindications above).
As there are no data available on the safety, immunogenicity or efficacy of MMRV
vaccines in HIV-infected children, MMRV vaccine should not be administered as
a substitute for MMR vaccine when vaccinating these children.25,48
Persons receiving immunosuppressive therapy

MMR-containing vaccines may be given to persons on low-dose systemic
corticosteroid therapy (e.g. children on doses of 2mg/kg per day for less than
1 week, and those on lower doses of 1mg/kg per day or alternate-day regimens
for longer periods). Persons receiving high-dose corticosteroids can receive
MMR-containing vaccines after corticosteroid therapy has been discontinued
for at least 1 month (see 4.9.9 Contraindications above).46 Some experts
suggest withholding lower doses of steroids 2 to 3 weeks prior to vaccination
with live viral vaccines, if this is possible.46,48 (See also 3.3.3 Vaccination of
immunocompromised persons.)
Household contacts of persons who are immunocompromised

Household contacts of persons who are immunocompromised, should ensure
that they are age-appropriately vaccinated against, or are immune to, measles,
as well as mumps, rubella and varicella. MMR-containing vaccines can be safely
administered to household contacts, as measles, mumps and rubella vaccine
viruses are not transmissible from vaccinated persons to others.25 If using MMRV
vaccine, see 4.22 Varicella for information regarding varicella vaccine virus
transmission.
4.9 MEASLES
Immunoglobulin-containing products should not be administered for 3 weeks

following vaccination with measles-containing vaccines, unless the benefits
exceed those of vaccination. If immunoglobulin-containing products are
administered within this interval, the vaccinated person should either be
revaccinated later at the appropriate time following the product (as indicated in
Table 3.3.6), or be tested for immunity 6 months later and then revaccinated if
seronegative.
Persons receiving long-term aspirin or salicylate therapy

There is no need to avoid salicylates before or after MMR or MMRV vaccination.
Persons receiving long-term salicylate therapy (aspirin) can be vaccinated with
MMRV, if indicated, as the benefit is likely to outweigh any possible risk of Reye
syndrome occurring after vaccination with a varicella-containing vaccine (see
4.22 Varicella).
Persons with a history of thrombocytopenia

Thrombocytopenia is a rare adverse event following MMR vaccination (see
also 4.9.11 Adverse events below).1,50,51 In children with a past history of an
episode(s) of idiopathic thrombocytopenia purpura (ITP), the risk of vaccineassociated thrombocytopenia occurring following a dose of MMR vaccine has
been uncertain.25,51 However, a recent systematic review concluded that MMR
vaccination, either as a 1st or 2nd dose, did not lead to a recurrence of ITP.52
Personal or close family history of seizures or convulsions

Children with a personal or close family history of seizures or convulsions
should be given MMR or MMRV vaccine, provided the parents/carers
understand that there may be a febrile response 5 to 12 days after vaccination.25
Advice should be given regarding reducing fever with paracetamol and other
measures. Due to an increased risk of fever and febrile convulsions in 1st dose
recipients of MMRV vaccine, MMRV vaccines are only recommended for use as
the 2nd dose of MMR-containing vaccine (see 4.9.7 Recommendations above and
4.9.11 Adverse events below).
Tuberculin skin testing following MMR vaccination

Measles virus inhibits the response to tuberculin and tuberculin-positive persons
may become tuberculin-negative for up to a month after measles infection.25,53 As
such, tuberculin skin testing (Mantoux test) may be unreliable for at least 4 weeks
after the administration of measles-containing vaccines. There are no studies
on the effect of MMR or MMRV vaccination on the results of interferon-gamma
release assays (IGRAs).54

If using MMRV vaccine, additional adverse events relating to the varicella
vaccine component are outlined in 4.22 Varicella.
Adverse events following administration of MMR-containing vaccines are
generally mild and well tolerated.2 Adverse events are much less common after
the 2nd dose of MMR or MMRV vaccine than after the 1st dose.
Fever (with malaise and/or a rash, which is non-infectious) may occur after
MMR vaccination, most commonly between 7 to 10 days (range 5 to 12
days) after vaccination and lasting about 2 to 3 days. This coincides with the
period of peak measles vaccine virus replication. High fever (>39.4C) occurs
in approximately 5 to 15% of MMR vaccine recipients, and rash occurs in
approximately 5%.2,25 There is also an increased risk for febrile seizures in the
same time period of approximately 1 case per 3000 doses.25
Higher rates of fever were observed in clinical trials of both MMRV vaccines,
particularly following dose 1, when compared with giving MMR vaccine and
monovalent VV at the same time but at separate sites.28-31 Two post-marketing
studies in the United States identified an approximately 2-fold increased risk of
fever and febrile convulsions in 1st dose recipients of MMRV vaccine, who were
predominantly 1223 months of age, in the period 7 to 10 days55 (or 5 to 12 days)56
after vaccination, compared with recipients of separate MMR and VV vaccines.
MMRV vaccination resulted in 1 additional febrile seizure for every 2300 doses
compared to separate MMR and VV vaccination.55 An increase in fever or febrile
convulsions has not been identified after the 2nd dose of MMRV vaccine in the
United States, although most 2nd dose recipients were aged 46 years, an age at
which the incidence of febrile convulsions is low.57 These post-marketing studies
were in children who received ProQuad; however, it is anticipated that this side
effect profile would be similar in Priorix-tetra recipients.
A varicelliform rash may occur after MMRV vaccination (see 4.22.11 Adverse
events in 4.22 Varicella). The appearance of a rash after monovalent varicella
vaccine occurs in less than 5% of vaccine recipients (usually within 5 to 26 days),
and similar rates are observed with the use of MMRV vaccine.58
Anaphylaxis following the administration of MMR vaccine is very rare (less
than 1 in 1 million doses distributed).25 Although no cases of anaphylaxis were
reported in MMRV vaccine clinical trials, the incidence is likely to be similar to
that occurring with use of MMR vaccine. Anaphylaxis after vaccination is likely
due to anaphylactic sensitivity to gelatin or neomycin, not egg allergy (see 4.9.10
Precautions above).
Thrombocytopenia (usually self-limiting) has been very rarely associated with the
rubella or measles component of MMR vaccine, occurring in 3 to 5 per 100 000
doses of MMR vaccine administered.1,25,50,51 This is considerably less frequent
than after natural measles, mumps and rubella infections.51 Any association with
MMRV vaccine is expected to be similar.
It is uncertain whether encephalopathy occurs after measles vaccination. If it
does, it is at least 1000 times less frequent than as a complication from natural
infection.2,25
Other rare adverse events attributed to MMR vaccine include transient
lymphadenopathy and arthralgia (see 4.18 Rubella). Parotitis has been reported
rarely (see 4.11 Mumps).25
4.9 MEASLES
It is recommended that vaccine recipients or their parents/carers be advised

about possible symptoms, and given advice for reducing fever, including the use
of paracetamol for fever in the period 5 to 12 days after vaccination.
Autism, autistic spectrum disorder and inflammatory bowel disease are

not associated with the MMR vaccine. There has been no credible scientific
evidence to support this claim and most proponents of the link have retracted
this claim.59,60 There is now a substantial body of evidence to refute it61-64 (see
Appendix 4 Commonly asked questions about vaccination).
4.9.12 Public health management of measles

Measles is a notifiable disease in all states and territories in Australia. The public
health management of measles is described in Measles: national guidelines for public
health units37 (www.health.gov.au/cdnasongs) and is given urgent public health
priority. Refer to the national guidelines for current case definitions, testing and
post-exposure prophylaxis of contacts.
Further instructions about the public health management of measles can also
MMR vaccine (and MMRV in some instances) is recommended for post-exposure
prophylaxis within 72 hours of a non-immune individual being exposed to
measles. See Table 4.9.2 for detailed information. Administration of normal
human immunoglobulin (NHIG), rather than MMR or MMRV, is recommended
in some settings (see Part 5 Passive immunisation and Table 4.9.2).37 Post-exposure
prophylaxis should be given on the direction of public health authorities.
Children >12 months of age who have received 1 dose of measles-containing
vaccine can be offered their 2nd dose early (if at least 4 weeks after the 1st dose
has elapsed) if they are considered at risk of coming in contact with measles37
(see 4.9.7 Recommendations above and Table 4.9.2). If varicella vaccination is also
indicated, MMRV vaccine can be used, although MMRV vaccine is not routinely
recommended as the 1st dose of MMR-containing vaccine in children aged
<4 years (see 4.9.7 Recommendations above). If a child receives the 2nd dose of
measles-containing vaccine early, they are considered to have completed their
vaccination schedule and therefore do not require another dose at 18 months of
age or beyond, provided that the 2 doses were given at 12 months of age and at
least 4 weeks apart.
Table 4.9.2: P
ost-exposure prophylaxis 72 hours since exposed to measles
for non-immune individuals (adapted from Measles: national
guidelines for public health units)37
* A subsequent dose of MMR-containing vaccine (MMR or MMRV) should be provided at least

4 weeks after the 1st valid dose (a valid dose is one given at 12 months of age) to complete a
2-dose vaccine schedule (see 4.9.7 Recommendations above).
4.9 MEASLES
Age or immune status Measles-mumps-rubella (MMR) vaccination history

0 doses MMR or
1 dose MMR
2 doses MMR
unknown
Normal human
NHIG
NHIG
immunoglobulin
0.5 mL/kg to
0.5 mL/kg to
Immunocompromised (NHIG)
maximum of
maximum of
(any age)
0.5 mL/kg to
15mL
15mL
maximum of
15mL
NHIG
Not applicable
Not applicable
0.2 mL/kg
only if mother
has had <2 doses
Birth to 5 months
of MMR and no
history of past
measles infection,
otherwise no
NHIG
NHIG
Not applicable
Not applicable
6 to 8 months
0.2 mL/kg
MMR now, then
Not applicable
Not applicable
another dose at
12 months of age
9 to 11 months
or 4 weeks later
(whichever is
later)*
MMR*
MMR (or MMRV) Nil necessary
(unless 1st dose
12 months to <4 years
was given <4
weeks ago)
MMR if not
MMR if not
Nil necessary
pregnant*
pregnant
4 years
If pregnant, offer
If pregnant, offer
and born during or
NHIG (0.2mL/kg NHIG (0.2mL/kg
since 1966
to a maximum of
to a maximum of
15mL) and inform 15mL) and inform
obstetrician or GP obstetrician or GP

The product information for MMR and MMRV vaccines recommends that
women of child-bearing age should be advised not to become pregnant for
3 months after vaccination. The ATAGI instead recommends avoiding
pregnancy for 28 days after vaccination.38
The product information for Priorix, M-M-R II, Priorix-tetra and ProQuad states
that persons with a history of anaphylactic or anaphylactoid reactions to egg
should not be vaccinated. The ATAGI recommends instead that either Priorix,
M-M-R II, Priorix-tetra or ProQuad can be given in this situation.25
The product information for Priorix-tetra states that it should be given by SC
injection. The ATAGI recommends that it may also be given by IM injection.
The product information for ProQuad states that this vaccine is indicated for
vaccination in individuals 12 months through 12 years of age. The product
information for Priorix-tetra states that this vaccine can be used in persons from
9 months of age. The ATAGI recommends instead that both MMRV vaccines
can be given to persons up to 14 years of age. The ATAGI also recommends that
MMRV vaccine should not be used routinely as the 1st dose of MMR-containing
vaccine in children aged <4 years.
The product information for both MMRV vaccines states that salicylates should
be avoided for 6 weeks after vaccination, as Reye syndrome has been reported
following the use of salicylates during natural varicella infection. The ATAGI
recommends instead that non-immune persons receiving long-term salicylate
therapy can receive varicella-containing vaccine, as the benefit is likely to
outweigh any possible risk of Reye syndrome occurring after vaccination.
References
4.10.1 Bacteriology
Meningococcal disease is caused by the bacterium Neisseria meningitidis (or
meningococcus), a Gram-negative diplococcus. There are 13 known serogroups
distinguished by differences in surface polysaccharides of the outer membrane
capsule. Meningococcal serogroups are designated by letters of the alphabet.
Globally, serogroups A, B, C, W135 and Y most commonly cause disease.
Meningococci can be further classified by differences in their outer membrane
proteins, which are referred to as serotypes and serosubtypes.1 More recently,
molecular typing has been used to further differentiate meningococci. There is no
consistent relationship between serogroup or serotype/subtype and virulence.2

N.meningitidis can cause meningitis, septicaemia or a combination of the two.
Other localised infections, including pneumonia, arthritis and conjunctivitis,
may also occur but are uncommon. Septicaemia, with or without meningitis,
can be particularly severe. The overall mortality risk for invasive disease is high
(between 5 and 10%), despite appropriate antibiotic therapy.2 Of those who
survive, approximately 10 to 20% develop permanent sequelae, including limb
deformity, skin scarring and neurologic deficits.1 Prior invasive meningococcal
disease does not induce protective immunity against the implicated serogroup of
meningococci. Therefore, persons with a history of meningococcal disease should
still be vaccinated if required.
N.meningitidis is carried and transmitted only by humans. There are no known
animal reservoirs. Asymptomatic respiratory tract carriage of meningococci
is present in about 10% of the population, and the prevalence may be higher
when groups of people occupy small areas of living space.3,4 Recent studies
indicate that there may be a number of factors that contribute to the increased
risk of contracting meningococcal disease, including exposure to smokers, recent
illness, living in crowded conditions and multiple intimate kissing partners.2-4
Persons with inherited disorders of phagocytosis associated with properdin
deficiency or absence of the terminal components of complement, as well
as persons with functional or anatomical asplenia, have an increased risk of
meningococcal infection.1
The disease is transmitted via droplets and has an incubation period of between
1 and 10 days, but commonly 3 to 4 days.4 The capacity of meningococcal disease
to have a fulminant and rapidly fatal course in previously healthy (and usually
young) persons causes it to be greatly feared. Intensive public health follow-up
is required after each single case to trace contacts and to institute appropriate
public health measures for them. As a result of all these factors, this disease can
cause widespread community alarm and generate significant media interest.4
4.10 MENINGOCOCCAL DISEASE
4.10.3 Epidemiology
Meningococci cause both sporadic and epidemic disease throughout the world.
Serogroup A disease occurs predominantly in low-income countries, such as
those in Africa and Asia, while serogroup B is the major cause of sporadic
meningococcal disease in most developed countries, including Australia.
Serogroup C meningococci have been occasionally associated with small
clusters of meningococcal disease cases in schools, universities and nightclubs in
Australia in the past.5-7 Rarely, there are clusters of meningococcal disease cases
associated with serogroup B.8
As in other temperate climates, meningococcal disease cases occurring in
Australia tend to follow a seasonal trend, with a large proportion of cases
reported during late winter and early spring. The overall notification rate for
invasive meningococcal disease to the National Notifiable Diseases Surveillance
System reached a peak of 3.5 per 100 000 in 2001, but declined to 1 case per
100 000 in 2010.9,10 There have been considerable differences noted in the
incidence of meningococcal disease between Australian states and territories in
the past. Notifications include meningococcal disease cases that were diagnosed
on clinical grounds alone, and those cases that were confirmed by laboratory
methods such as culture, serology or nucleic acid testing of clinical material.
In 2009, 259 cases were reported nationally, of which 194 were laboratoryconfirmed.9,10 The majority of laboratory-confirmed meningococcal cases were
serogroup B (83%) and serogroup C (5.6%).10 There has been a sustained decline
in serogroup C meningococcal disease among the 119 years age group, as
well as other age groups not targeted in the vaccine program, since the 2003
introduction of routine serogroup C vaccination and catch-up programs.9-11 In
other countries that introduced a meningococcal C vaccination program, this
herd immunity effect has also resulted in a reduction in incidence in age groups
not targeted by the program.12-14
Meningococcal disease can occur in any age group, but a large proportion of
cases occur in those <5 years of age, with a secondary peak seen in the 1524
years age group.10 In Australia, meningococcal disease in the <5 years age group
is due predominantly to infection with serogroup B meningococci; very few
cases of serogroup C meningococcal disease are now seen in this age group.10,11
In the 1519 years age group, both serogroup B and C disease were seen before
the introduction of the meningococcal C conjugate vaccine in 2003. In contrast
to Australia, New Zealand experienced an epidemic of meningococcal disease
that was almost exclusively associated with a particular strain of serogroup B
(B:4:P1.7b,4).15,16 A meningococcal outer membrane vesicle vaccine (MeNZB)
was used exclusively in New Zealand, and the program ceased in 2008.15,16 This
vaccine was only known to be effective against the serotype and serosubtype of
the New Zealand serogroup B strain and was not available in Australia.
There are different types of meningococcal vaccines:

meningococcal C conjugate vaccines (MenCCV)
Haemophilus influenzae type bmeningococcal C combination vaccine (HibMenCCV)
quadrivalent meningococcal conjugate vaccines (4vMenCV)
quadrivalent meningococcal polysaccharide vaccines (4vMenPV).
Conjugate vaccines
Meningococcal C conjugate vaccines (MenCCV)
Meningitec Pfizer Australia Pty Ltd (meningococcal serogroup
CCRM197 conjugate). Each 0.5mL pre-filled syringe contains 10g
Neisseria meningitidis serogroup C oligosaccharide conjugated to
approximately 15g of non-toxic Corynebacterium diphtheriae CRM197
protein; aluminium phosphate.
Menjugate Syringe CSL Limited/Novartis Vaccines and Diagnostics
Pty Ltd (meningococcal serogroup CCRM197 conjugate). Lyophilised
powder in a monodose vial with a pre-filled diluent syringe. Each
0.5mL reconstituted dose contains 10g N.meningitidis serogroup C
oligosaccharide conjugated to 12.525g of non-toxic C.diphtheriae
CRM197 protein; 1.0mg aluminium hydroxide.
NeisVac-C Baxter Healthcare (meningococcal serogroup Ctetanus
toxoid conjugate). Each 0.5mL pre-filled syringe contains 10 g
N.meningitidis serogroup C polysaccharide conjugated to 1020g of
tetanus toxoid; 0.5mg aluminium as aluminium hydroxide.
Combination vaccine that contains meningococcal C

Menitorix GlaxoSmithKline (Haemophilus influenzae type b [PRP-T]meningococcal serogroup Ctetanus toxoid conjugate). Lyophilised
powder in a monodose vial with a pre-filled diluent syringe. Each
0.5mL reconstituted dose contains 5g Hib capsular polysaccharide
(PRP) conjugated to 12.5g tetanus toxoid, and 5g N.meningitidis
serogroup C polysaccharide conjugated to 5g tetanus toxoid; traces
of trometamol and sucrose.
Quadrivalent meningococcal conjugate vaccines (4vMenCV)

Menactra Sanofi Pasteur Pty Ltd (meningococcal serogroups A,
C, W135, Ydiphtheria toxoid conjugate). Each 0.5mL monodose vial
4.10.4 Vaccines
contains 4g each of serogroups A, C, W135 and Y polysaccharides

conjugated with a total of approximately 48g of a diphtheria toxoid
protein.
Menveo CSL Limited/Novartis Vaccines and Diagnostics Pty
Ltd (meningococcal serogroups A, C, W135, YCRM197 conjugate).
Lyophilised powder containing serogroup A (MenA) in a monodose
vial with a pre-filled syringe or vial containing serogroups C, W135 and
Y (MenCWY) in saline suspension. Each 0.5mL reconstituted dose
contains 10g of serogroup A and 5g each of serogroups C, W135
and Y oligosaccharides individually conjugated with up to 33.3g of
non-toxic C.diphtheriae CRM197 protein; sucrose.
All conjugate vaccines induce immunity within 10 to 14 days of administration.

MenCCVs confer protection only against serogroup C disease. 4vMenCVs will
provide protection against four serogroups of meningococci: serogroups A, C,
W135 and Y. Neither MenCCV nor 4vMenCV will provide protection against
serogroup B meningococcal disease.
MenCCVs have been used in an infant schedule in many countries, including
Australia.11-13,17-19 The vaccine effectiveness following 1 dose of MenCCV has
been estimated to range from 83 to 100%.13,17 There has been a sustained decline
in serogroup C meningococcal disease, which has also been observed in age
groups not targeted in vaccination programs, both in Australia and overseas.11,14
Duration of immunity is still uncertain. However, current serogroup C
meningococcal disease epidemiology in Australia suggests ongoing protection in
those groups previously vaccinated.11
Hib-MenCCV can be administered where a booster dose of H.influenzae
type b and primary vaccination for meningococcal serogroup C is required.
The immunogenicity and safety of Hib-MenCCV as a booster dose has been
demonstrated in clinical trials and in the United Kingdom, where this vaccine is
now administered as part of the infant schedule.20-25
Several clinical trials have demonstrated the immunogenicity of 4vMenCV,
with human serum bactericidal assay titres of 1:4 reported in adolescents and
young adults.26-28 There have been a number of studies examining 4vMenCV in
children.29-31 All studies indicated that 4vMenCVs were safe and immunogenic in
both infants and children.29-33 Menveo has demonstrated superiority to Menactra
in serum bactericidal assays to serogroups A, W135 and Y (and variably also to
serogroup C); however, the clinical relevance of this is currently unknown.27,34-36
Quadrivalent meningococcal polysaccharide vaccines (4vMenPV)

Mencevax ACWY GlaxoSmithKline (meningococcal serogroups A,
C, W135 and Y polysaccharides). Lyophilised pellet in a monodose vial
with separate saline diluent. Each 0.5mL reconstituted dose contains
50g of each meningococcal serogroup polysaccharide; 12.6mg
sucrose; 0.1mg trometamol.
Menomune Sanofi Pasteur Pty Ltd (meningococcal serogroups A, C,
W135 and Y polysaccharides). Lyophilised powder in a monodose vial
with separate saline diluent. Each 0.5mL reconstituted dose contains
50g of each meningococcal serogroup polysaccharide; 2.55mg
lactose.
4vMenPV provides protection against serogroups A, C, W135 and Y. These

vaccines induce antibodies in 10 to 14 days in 90% of recipients >2 years of age.
Immunity decreases markedly during the first 3 years following a single dose of
vaccine, particularly in infants and young children. However, clinical protection
persists for at least 3 years in school-aged children and adults.
The duration of immunity is further complicated by the induction of
immunological hyporesponsiveness to the serogroup C component
following repeated vaccination with 4vMenPV, as revaccination results in
a reduced antibody response compared with the primary immunisation.37
This phenomenon has been noted in both children and adults.38-40 The
demonstration of subsequent hyporesponsiveness has led to the concern that
vaccinating persons at low risk may reduce the effectiveness of revaccination
in a subsequent high-risk situation, although this has not been clinically
demonstrated. This hyporesponsiveness can be overcome with meningococcal
conjugate vaccines,38 although additional doses of a conjugate vaccine may
be required in young children. There is little response to the serogroup C
component of the 4vMenPV before 18 months of age and little response to
serogroup A before 3 months of age.41

Conjugate vaccines
Menjugate Syringe must be reconstituted by adding the entire contents of the
diluent syringe to the vial and shaking until the powder is completely dissolved.
Reconstituted vaccine should be used immediately.
Polysaccharide vaccines
The product information for NeisVac-C states that this vaccine can be stored at
+25C for a period of up to 9 months. Refer to product information for further vaccine
storage details.
Menitorix must be reconstituted by adding the entire contents of the diluent
syringe to the vial and shaking until the powder is completely dissolved.
Reconstituted vaccine should be used as soon as practicable. If storage is
necessary, hold at +2C to +8C for not more than 24 hours.
Menveo must be reconstituted by adding the entire contents of the liquid
MenCWY syringe/vial to the lyophilised MenA vial and shaking until the
powder is completely dissolved. Reconstituted vaccine should be used as soon
as practicable. If storage is necessary, hold at +2C to +8C for not more than
24 hours.
Mencevax ACWY must be reconstituted by adding the entire contents of the
diluent container to the vial and shaking until the powder is completely
dissolved. Reconstituted vaccine should be used as soon as practicable. If storage
is necessary, hold at +2C to +8C for not more than 8 hours.
Menomune must be reconstituted by adding the entire contents of the diluent
container to the vial and shaking until the powder is completely dissolved.
Reconstituted vaccine must be used within 24 hours.

Conjugate vaccines
The dose of all meningococcal conjugate vaccines (MenCCV, Hib-MenCCV,
4vMenCV) is 0.5mL to be given by IM injection. Do not mix with other vaccines
in the same syringe.
MenCCVs are registered for use in infants from 6 weeks of age. Hib-MenCCV
is registered for use in infants from 6 weeks of age, and can be administered as
the primary dose of serogroup C meningococcal vaccine and the booster dose
of Hib vaccine.
Both 4vMenCVs may be given from 9 months of age (see 4.10.12 Variations
from product information below).
Either MenCCV or Hib-MenCCV may be administered simultaneously
with other vaccines in the NIP schedule (see 4.10.12 Variations from product
information below).
The dose of both 4vMenPVs is 0.5mL, to be given by SC injection.
4vMenPVs are registered for use in children 2 years of age, adolescents and
adults.
4vMenPV may also be co-administered with other vaccines.
Experience from the use of conjugate Hib vaccines suggests that the different
brands of conjugate meningococcal vaccines are interchangeable.
There are limited data available on the length of time that should elapse before
administration of 4vMenCV after giving MenCCV. The ATAGI recommends a
minimum period of 8 weeks before 4vMenCV is given.
There are limited data available on the length of time that should elapse
before administration of either MenCCV or 4vMenCV after giving 4vMenPV.
A minimum period of 6 months is recommended before conjugate vaccine is
given.37,39,40
Previous meningococcal disease, regardless of the serogroup, is not a
contraindication to the administration of any meningococcal vaccine.
Meningococcal C conjugate-containing vaccines

Children aged 12 months
It is recommended that a single dose of MenCCV or Hib-MenCCV be given

to all children at the age of 12 months.
Hib-MenCCV is administered as a single dose at 12 months of age where a
booster dose of Hib and the primary dose of serogroup C meningococcal vaccine
are required.
Vaccination before 12 months of age is not recommended, except in infants
with inherited defects of properdin or complement, or functional or anatomical
asplenia (see Persons at high risk for meningococcal disease below).43,44 Infants,
other than those described in the circumstances below, who receive dose(s) of
vaccine at <12 months of age should be given a further dose at 12 months of age
or a minimum of 8 weeks after the last dose, whichever is later. However, it is
not necessary to recall older children who received 3 doses of MenCCV before
12 months of age, as there has been no evidence to date of vaccine failure in
infants vaccinated according to a 2, 4, 6 months schedule.
Persons at high risk for meningococcal disease
MenCCV is recommended for persons in the following situations:

Close (household or household-like) contacts of meningococcal disease cases
due to serogroup C, who are 6 weeks of age and who have not previously
been vaccinated. A single dose of MenCCV is recommended under these
circumstances, and in other instances where required for the control of
disease outbreaks caused by serogroup C meningococci (refer to Guidelines
for the early clinical and public health management of meningococcal disease in
Australia).2
Interchangeability of meningococcal vaccines
Infants from 6 weeks to 12 months of age who have medical conditions

that put them at high risk of meningococcal disease, such as functional or
anatomical asplenia43 or inherited defects of properdin or complement,
persons receiving treatment with eculizumab (a monoclonal antibody
directed against complement component C5),45 or those post haematopoietic
stem cell transplant (HSCT), are recommended to receive up to 2 doses of
MenCCV vaccine prior to 12 months of age. (See also 3.3 Groups with special
vaccination requirements.)

Infants with these conditions who are 6 weeks to <6 months of age require
2 doses of MenCCV, given at least 8 weeks apart, followed by a dose of
4vMenCV at 12 months of age. Those who are 6 to 11 months of age, and
have not previously received MenCCV, require 1 dose of MenCCV, followed
by a dose of 4vMenCV at 12 months of age or 8 weeks after the 1st dose,
whichever is later.
Infants who received a dose of MenCCV, rather than 4vMenCV, at 12 months

of age, should be vaccinated with 2 subsequent doses of 4vMenCV (see
Quadrivalent meningococcal conjugate and polysaccharide vaccines below
and 3.3 Groups with special vaccination requirements).
Booster doses
Currently there are no indications for booster doses following either MenCCV
or Hib-MenCCV. Studies assessing whether there is a need for booster doses are
being conducted.
Quadrivalent meningococcal conjugate and polysaccharide vaccines

Routine vaccination with 4vMenCV or 4vMenPV is not recommended.46 Where
not otherwise contraindicated, a single dose of 4vMenCV should be administered
in preference to 4vMenPV. A single dose of 4vMenCV, unless otherwise stated, is
recommended for persons in the following situations:
Laboratory personnel who frequently handle N.meningitidis.2
Travellers (aged 9 months) who intend visiting parts of the world where
epidemics of group A, W135 or Y disease are frequent (a current list of those
countries is available from the World Health Organization at either www.
who.int/ith or www.who.int/disease-outbreak-news).
Close (household or household-like) contacts, aged 9 months of age,47
of cases of serogroup A, W135 or Y meningococcal disease, or in outbreaks
caused by these serogroups. Use 4vMenCV in preference to 4vMenPV in
these circumstances, unless the latter is the only vaccine available.2
Pilgrims attending the annual Hajj in Saudi Arabia. Saudi Arabian authorities
require a valid certificate of vaccination as a condition to enter the country.
Requirements are published in the World Health Organization Weekly
Epidemiological Record annually. Follow links under publications at www.who.
int/ith.
Where 4vMenCV is contraindicated, a single dose of 4vMenPV can be given to

persons aged 2 years, unless otherwise indicated.
Booster doses or revaccination
Although the duration of protection following 4vMenCV remains unknown,

persons with medical conditions that place them at high risk of meningococcal
disease (as described above) who have completed a 2-dose primary schedule
of 4vMenCV, should receive 4vMenCV at 5-yearly intervals thereafter, until
further data becomes available.36,49,50 This includes high-risk infants who have
received MenCCV in infancy, followed by 2 doses of 4vMenCV in the 2nd year
of life. (See also 3.3 Groups with special vaccination requirements and Table 3.3.5
Recommendations for vaccination in persons with functional or anatomical asplenia.)
Persons aged 9 months with a medical condition that places them at high risk
of meningococcal disease, and who have previously received 4vMenPV, should
receive a booster dose of 4vMenCV, 3 years after their last dose of 4vMenPV.
Thereafter, administer 4vMenCV every 5 years.
In persons with other risks for meningococcal disease, such as laboratory
personnel or those travelling to endemic or hyperendemic regions, a dose of
4vMenCV should be administered every 5 years if the risk of meningococcal
exposure is ongoing.
For those aged 2 years with underlying risk factors, but in whom 4vMenCV is
contraindicated, ongoing boosting with 4vMenPV is recommended at 5-yearly
intervals unless otherwise indicated.

Meningococcal vaccines are not routinely recommended for pregnant or
breastfeeding women,1,51,52 but can be given where clinically indicated (see 4.10.7
Children (aged 9 months) and adults with high-risk medical conditions,

such as functional or anatomical asplenia43,44 or complement component
disorders (C5-C9, properdin, factor D or factor H), persons receiving
treatment with eculizumab (a monoclonal antibody directed against
complement component C5),45 or those post HSCT. In persons with these
risk factors, a 2-dose primary schedule of 4vMenCV is recommended, with
doses given approximately 8 weeks apart.48 Give 4vMenCV at least 8 weeks
after any previous MenCCV doses. In young children who have received 1 or
more doses of MenCCV prior to 12 months of age, the 1st dose of 4vMenCV
is recommended at 12 months of age. The 2nd 4vMenCV dose should be
provided by 18 months of age. (See also 3.3 Groups with special vaccination
requirements and Table 3.3.5 Recommendations for vaccination in persons with
functional or anatomical asplenia.) For persons who have previously received a
dose of 4vMenPV, a booster dose of 4vMenCV, 3 years after the last dose of
4vMenPV, is recommended (see Booster doses or revaccination below).

The only absolute contraindications to meningococcal vaccines are:
anaphylaxis following a previous dose of any meningococcal vaccine
Previous meningococcal disease, regardless of the serogroup, is not a
contraindication to administration of any meningococcal vaccine.

Common adverse events caused by meningococcal conjugate vaccines are
pain, redness and swelling at the site of injection, fever, irritability, drowsiness,
decreased appetite and headaches.13,21,23-26,29 There are some age-related
differences in the type of adverse events following vaccination, with systemic
adverse events tending to decrease with increasing age, and local adverse events
tending to increase with increasing age. Headache, anorexia, fever and chills
were more likely to be reported in the adolescent and adult age groups following
administration of 4vMenCV.26,29 Among recipients of 4vMenCV, rash and nausea
were common. However, serious general adverse events are rare.26,29
The United States Vaccine Adverse Event Reporting System (VAERS) previously
reported a series of cases of Guillain-Barr syndrome (GBS) temporally
associated with the introduction of the 4vMenCV, Menactra.53,54 The likelihood
of coincidentally experiencing GBS after administration of 4vMenCV is expected
to be greater among persons with a history of GBS than among persons with
no history of GBS. Recent safety studies, during which over 2 million doses of
Menactra were administered, found there was no risk of GBS after Menactra
in the general population, and extrapolated these data to conclude that
persons with a history of GBS are not at higher risk than they are after other
vaccines that have no association with GBS.55,56 It is, therefore, recommended
that 4vMenCV can be administered to persons with previous GBS in whom
vaccination is indicated.
Local adverse events after 4vMenPV include erythema, induration, tenderness,
pain and local axillary lymphadenopathy. However, these reactions are usually
mild and infrequent. Fever and chills occur in approximately 2% of young
children, and may persist for 48 hours or longer, but significant general adverse
events are rare.
4.10.11 Public health management of meningococcal disease

Meningococcal disease is notifiable in all states and territories in Australia.
Further instructions about the public health management of meningococcal
disease, including management of cases of meningococcal disease and their
contacts, should be obtained from state/territory public health authorities (see
If a diagnosis of meningococcal disease is suspected, the patient should be

immediately given parenteral (usually IM) penicillin and transferred to hospital.
A potential outbreak of meningococcal disease in an institutional or community
setting is a public health emergency needing a rapid response from clinicians
and public health practitioners. The decision to control an outbreak with a
vaccination program should be made by the appropriate Public Health Unit,
following the Guidelines for the early clinical and public health management of
meningococcal disease in Australia.2

The product information for meningococcal C conjugate vaccines states that,
under the age of 12 months, either 2 (NeisVac-C) or 3 (Meningitec and Menjugate
Syringe) doses of vaccine are required. The ATAGI recommends instead that
meningococcal C vaccination is routinely not recommended before 12 months of
age (unless specifically indicated).
The product information for Meningitec states that an allergic reaction following
a previous dose is a contraindication to further doses. The ATAGI recommends
The product information for NeisVac-C states that the vaccine should not be
administered with pneumococcal conjugate vaccine, hepatitis B vaccine or
PRP-OMP Haemophilus influenzae type b vaccine unless medically important.
The ATAGI recommends instead that the vaccine may be administered
simultaneously with other vaccines in the NIP. There have been publications
citing the co-administration of MenCCV with other combination vaccines and it
was found to be immunogenic and safe.57,58
The product information for Menactra states that a previous episode of GuillainBarr syndrome is a contraindication to vaccination with Menactra. The ATAGI
recommends instead that either of the available 4vMenCVs can be administered.
The product information for Menactra states that this vaccine is indicated for use
in persons aged 255 years. The ATAGI recommends instead that Menactra can
be given to persons aged 9 months of age.
The product information for Menveo states that this vaccine is indicated for use
in persons 11 years of age. The ATAGI recommends instead that Menveo can be
given to persons aged 9 months of age.
The product information for all meningococcal vaccines (MenCCV, 4vMenCV
and 4vMenPV) states that there are no data on the use of these vaccines in
lactating women. The ATAGI recommends that breastfeeding women can be
vaccinated.
The product information for both 4vMenCVs states that vaccine should be
administered as a single dose. The ATAGI recommends that these vaccines can be
given in a 2-dose primary schedule to children (aged 9 months) and adults with
high-risk medical conditions.
The product information for both 4vMenCVs states that the need for, or timing
of, booster doses has not yet been determined. The ATAGI recommends that,
until more data become available, individuals with underlying risk factors,
including functional or anatomical asplenia, should continue to receive
4vMenCV at 5-yearly intervals.
References
4.11 MUMPS
4.11.1 Virology

Mumps is an acute viral illness with an incubation period of 12 to 25 days.2
Transmission is via respiratory secretions, including aerosol transmission, or by
direct contact with saliva or possibly urine.2 Asymptomatic infection occurs in
one-third of cases.3 Symptomatic disease ranges from mild upper respiratory
symptoms to widespread systemic involvement.3 A high proportion of mumps
infections involve non-specific symptoms including fever, headache, malaise,
myalgia and anorexia.4 The characteristic bilateral, or occasionally unilateral,
parotid swelling occurs in 60 to 70% of clinical cases.4,5 Maximum infectiousness
occurs between 2 days before onset of illness and 4 days afterwards, but patients
may be infectious from 7 days before parotid swelling to 9 days after.2 Meningeal
symptoms and signs appear in approximately 10% of cases, but permanent
neurologic sequelae are rare.2 Mumps encephalitis has been estimated to occur
in 12 per 10 000 cases, with a case-fatality rate of around 1.0%.6 Deafness is
relatively common in mumps meningoencephalitis, although permanent nerve
deafness is rare (1 in 20 000 infections). Orchitis (usually unilateral) has been
reported in up to 15 to 30% of clinical mumps cases in post-pubertal males,
but subsequent sterility is rare.6 Symptomatic involvement of other glands and
organs has been observed less frequently (pancreatitis, oophoritis, hepatitis,
myocarditis, thyroiditis, mastitis).1,4
Mumps infection during the first trimester of pregnancy may result in
spontaneous abortion.3,4 Maternal infection is not associated with an increased
risk of congenital malformation.3,4
4.11.3 Epidemiology
Mumps is reported worldwide. Prior to universal vaccination, mumps was
primarily a disease of childhood with the peak incidence in the 59 years
age group. However, since 2000, peak rates have been reported in older
adolescents and young adults, especially the 2034 years age group.7-10
Between 2002 and 2004, mumps notifications were the lowest recorded in
Australia, averaging 0.4 per 100 000.11 In 2005, notifications increased to
1.2 per 100 000, peaking at 2.7 per 100 000 in 2007, but have since declined to
less than 1 per 100 000 since 2009.10,11 There have also been recent outbreaks of
mumps in the United States and Europe, where the peak rates of disease have
been in the 1824 years age group.12-15
4.11 MUMPS
Mumps is a paramyxovirus, genus Rubulavirus, with a single-stranded RNA

genome. It is rapidly inactivated by heat, formalin, ether, chloroform and light.1
Similar to measles, persons born in the late 1960s to mid-1980s (especially the
19781982 birth cohort) are recognised to be at a greater risk of mumps. Many
missed being vaccinated or acquiring mumps infection as infants (when vaccine
coverage was low and disease incidence was decreasing), and may also have
missed catch-up vaccinations during their school years as part of either the
Measles Control Campaign (which only targeted primary-school-aged children)
or the Young Adult Measles Control Campaign (which did not result in high
coverage).16,17 During outbreaks, mumps attack rates are lowest in persons who
have received 2 doses of mumps-containing vaccines, as this provides optimal
long-term protection.5,13 In Australia, over the 11-year period from 1996 to 2006,
mumps was reported as the underlying cause of 5 deaths, all in adults aged over
80 years.7-10
4.11.4 Vaccines
Monovalent mumps vaccine is not available in Australia. Mumps vaccination
is provided using either measles-mumps-rubella (MMR) or measles-mumpsrubella-varicella (MMRV) vaccines. Two quadrivalent combination vaccines
containing live attenuated measles, mumps, rubella and varicella viruses
(MMRV) are registered in Australia.
Clinical trials of MMR vaccine indicate 95% mumps seroconversion after a single
dose and up to 100% after a 2nd dose.4 However, outbreak investigations and
post-marketing studies have reported 1-dose vaccine effectiveness to be between
60 and 90%.13,18 A Cochrane review reported 1-dose vaccine effectiveness to be
between 69% and 81% for the vaccine containing the Jeryl Lynn mumps strain
and between 70% and 75% for the vaccine containing the Urabe strain.19 While
protection is greater in 2-dose vaccine recipients, recent outbreaks have reported
mumps in 2-dose vaccine recipients, particularly young adults who received
their vaccines more than 10 years previously.14,15,20,21
Combination MMRV vaccines have been shown, in clinical trials, to produce
similar rates of seroconversion to all four vaccine components compared with
MMR vaccine and monovalent varicella vaccines administered concomitantly at
separate injection sites.22-25
See further information on MMR and MMRV vaccines in 4.9 Measles and
4.22 Varicella.
Trivalent measlesmumpsrubella (MMR) vaccines


4.11 MUMPS



The dose of Priorix (MMR) vaccine for both children and adults is 0.5mL to be
The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5mL to be
given by SC injection.
For children <14 years of age, the dose of MMRV vaccine is 0.5mL to be given by
SC injection. Priorix-tetra may also be given by IM injection.27

pneumococcal conjugate vaccine),28 using separate syringes and injection sites. If
MMR or MMRV vaccine is not given simultaneously with other live attenuated
parenteral vaccines, they should be given at least 4 weeks apart.

If MMR vaccine is given at <12 months of age, there is still a need for 2 vaccine
doses to be administered at 12 months of age (see 4.9 Measles).
Children
Two doses of mumps-containing vaccine are recommended for all children. The
(see Table 4.9.1 in 4.9 Measles and Table 4.22.1 in 4.22 Varicella). (See also 4.9.11
Adverse events in 4.9 Measles and 4.22.11 Adverse events in 4.22 Varicella.)
The 2nd dose of mumps-containing vaccine is recommended to be given
routinely at 18 months of age as MMRV vaccine. This is to commence from
July 2013 once MMRV vaccine(s) are available under the NIP (see Table 4.9.1
in 4.9 Measles and Table 4.22.1 in 4.22 Varicella). The recommended age for
administration of the 2nd dose of mumps-containing vaccine will be moved
down from 4 years of age, to provide earlier 2-dose protection against measles,
mumps and rubella, and to improve vaccine uptake (see 4.11.3 Epidemiology
above).
12 months of age); however, parents/carers should be advised regarding
the small but increased risk of fever and febrile seizures (compared with that
expected following MMR vaccine).

Two doses of mumps-containing vaccine are recommended for all nonimmune adolescents and adults (see 4.9 Measles). All persons born during or
since 1966 who are 18 months of age (or, until catch-up following the move
of the 2nd NIP dose of measles-containing vaccine to 18 months of age is
completed, are 4 years of age) should have documented evidence of 2 doses
of MMR-containing vaccine (administered at least 4 weeks apart with both
doses administered at 12 months of age) or have serological evidence of
protection for measles, mumps and rubella.
It is recommended that all adolescents and young adults have their vaccination
records reviewed to ensure they have received 2 doses of MMR vaccine (see
4.11.3 Epidemiology above).
4.11 MUMPS

early as 9 months of age in high-risk circumstances (see 4.9 Measles).
MMRV vaccines are not recommended for use in persons 14 years of age, due to
a lack of data on safety and immunogenicity/efficacy in this age group. If a dose
of MMRV vaccine is inadvertently given to an older person, this dose does not
need to be repeated.
For further information on the recommendations for MMR and MMRV vaccines,
see 4.9 Measles and 4.22 Varicella.
Serological testing for immunity to mumps

Serological testing for immunity to mumps (and measles, rubella and varicella) is
not recommended before or after routine administration of the 2-dose childhood
schedule of these vaccines.
However, serological testing for mumps (and measles and rubella) can be
performed in cases where a history of natural immunity or 2 doses of vaccine
administration is uncertain (see Adults and adolescents above). Serology is
indicated in special situations, such as pre-pregnancy planning (see also 4.9
Measles, 4.18 Rubella and 4.22 Varicella). Serological tests to investigate immunity
to mumps are generally sensitive at detecting antibody produced by both prior
natural infection and vaccination, although sensitivity varies by assay and
the clinical setting (e.g. time since vaccination).4 Interpretation of the results
of serological testing may be enhanced by discussion with the laboratory that
performed the test, ensuring that relevant clinical information is provided. An
alternative to serological testing is presumptive administration of MMR vaccine
dose(s). There is no known increase in adverse events from vaccinating those
with pre-existing immunity to one or more of the vaccine components (see 4.11.11
Adverse events below).

MMR-containing vaccines are contraindicated in pregnant women. Pregnancy
should be avoided for 28 days after vaccination.29
MMR vaccines can be given to breastfeeding women. (See also 4.18 Rubella.)
See also 4.9 Measles, 4.18 Rubella, 4.22 Varicella and 3.3 Groups with special
vaccination requirements, Table 3.3.1 Recommendations for vaccination in pregnancy
for more information.
For information on contraindications to MMR and MMRV vaccines, see 4.9
Measles and 4.22 Varicella.
4.11.10 Precautions
For additional precautions related to MMR and MMRV vaccines, see 4.9 Measles
and 4.22 Varicella.

The most common adverse events following mumps vaccination are fever and
parotitis.4 Parotitis occurs most commonly from 10 to 14 days after vaccination.
The incidence varies by vaccine strain; in studies of the Jeryl Lynn vaccine strain,
parotid and/or submandibular swelling occurred in 0.5 to 1.6% of recipients.4,30,31
An increased risk of aseptic meningitis has been observed after vaccination with
the Urabe strain of mumps vaccine in some countries.4 However, the Urabe strain
is not used in Australia. MMR and MMRV vaccines available in Australia contain
a Jeryl Lynn-derived strain of mumps, which is not associated with an increased
risk of aseptic meningitis.32,33
For further information on the adverse events associated with MMR and MMRV
vaccines, see 4.9 Measles and 4.22 Varicella.
4.11.12 Public health management of mumps

Mumps is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of mumps, including
management of cases of mumps and their contacts, should be obtained from
state/territory public health authorities (see Appendix 1 Contact details for
Australian, state and territory government health authorities and communicable
disease control).
Mumps-containing vaccine does not provide protection if given after an
individual has been exposed to mumps.1,34 However, if the exposure did not
result in infection, the vaccine would induce protection against subsequent
infection. Normal human immunoglobulin (NHIG) has been shown not to be of
value in post-exposure prophylaxis for mumps.1,34

For information on MMR and MMRV vaccines, see 4.9 Measles and 4.22 Varicella.
References
4.11 MUMPS
4.12 PERTUSSIS
4.12.1 Bacteriology
Pertussis (whooping cough) is caused by Bordetella pertussis, a fastidious, Gramnegative, pleomorphic bacillus. There are other organisms (such as Bordetella
parapertussis, Mycoplasma pneumoniae and Chlamydia pneumoniae) that can cause a
pertussis-like syndrome.1

Pertussis is a respiratory infection with an incubation period of 7 to 20 days. In
unvaccinated persons, B.pertussis is highly infectious, spreading by aerosols
to 90% of susceptible household contacts.2 Natural infection does not provide
long-term protection and repeat infection can occur.2 The characteristic
paroxysmal cough with inspiratory whoop seen in unvaccinated children is less
common in individuals who have varying degrees of immunity acquired from
vaccination or infection.3 It has been estimated that B.pertussis accounts for up
to 7% of cough illnesses per year in adults and, each year, more than 25% of
adults experience a coughing illness of at least 5 days duration.4 Even in adults,
pertussis can be associated with significant morbidity, with cough persisting
for up to 3 months, and other significant symptoms, such as sleep disturbance
or, rarely, rib fracture.5 Identification of pertussis is limited by patient and
physician awareness and, in some cases, the limited sensitivity of diagnostic
tests; it is generally believed to be significantly under-diagnosed (refer to
4.12.11 Public health management of pertussis below).
Death due to pertussis is rare in people aged 1070 years. However, the casefatality rate in unvaccinated infants <6months of age is estimated to be 0.8%.6,7
The most common cause of death in persons with pertussis infection is pertussis
pneumonia, sometimes complicated by seizures and hypoxic encephalopathy.3
4.12.3 Epidemiology
Despite a long-standing immunisation program, pertussis remains highly
prevalent in Australia and the least well controlled of all vaccine-preventable
diseases. Epidemics occur every 3 to 4 years. In unvaccinated populations, these
outbreaks can be very large. In vaccinated populations, outbreaks are smaller,
with greatly reduced mortality and morbidity, and may continue to occur every
3 to 4 years or be more widely spaced.8 The maximal risk of infection and severe
morbidity is before infants are old enough to have received at least 2 vaccine
doses.9 In recent years, among highly immunised communities, many cases of
pertussis have occurred in adults and adolescents due to waning immunity.8,10
These persons are a significant reservoir of infection. Evidence from studies of
infant pertussis cases indicates that household contacts and carers are frequently
the source of infection, with parents identified as the source for more than
50% of cases.11 However, Australian studies have shown that in settings where
notification rates in children are high, siblings are a significant source of infant
302 The Australian Immunisation Handbook 4.12 (Pertussis updated March 2015)
Between 1995 and 2012, multiple epidemics of pertussis occurred in Australia;

however, the timing and frequency of these varied by geographical location. The
highest annual incidence of notifications (173 cases per 100000 population) was
reported in 2011, with 38732 notified cases.19
There have been a number of changes introduced to the NIP schedule over
time in an attempt to improve control of pertussis. Introduction of a 5th dose of
diphtheria, tetanus and whole-cell pertussis vaccine (DTPw) for 45-year-old
children in August 1994 was followed by a decrease in notifications consistent
with a vaccine effect; first among children aged 5 and 6 years, then by those
in the 79 years age group.8,20 Subsequently, the average age of pertussis
notifications continued to increase. By 2005, the proportion of notifications in
adults >20 years of age had reached 83%,8 compared with 40% in the early 1990s.
Acellular pertussis vaccine (DTPa) replaced DTPw for booster doses in 1997,
and for all doses from 1999. In 2003, the DTPa booster dose at 18 months of age
was removed from the NIP, moving the 1st booster dose to 4 years of age. The
removal of the 18-month booster dose from the schedule was based on evidence
from an Italian longitudinal study of DTPa trial participants. The study found
that a primary DTPa course at 2, 4 and 6 months of age provided 76 to 80%
protection from prolonged cough disease and this was maintained until 6 years
of age.21
In contrast to preceding epidemics, in the 20082011 epidemic period the
highest notification rates in Australia were in children <15 years of age and the
proportion of notifications in older adolescents and adults decreased. Notable
increases in pertussis notifications occurred for children between 3 and 9 years of
age.19 Although more accessible and sensitive diagnostic testing with polymerase
chain reaction (PCR) contributed to the rise in notified cases,22 waning of DTPa
vaccine-induced immunity has also been demonstrated to be a factor (refer to
4.12.4 Vaccines below).23-26 Although increased notification rates were observed
in the most recent epidemic, hospitalisation and death rates from pertussis did
not increase substantially.27 A high proportion of hospitalisations, and almost all
deaths, attributed to pertussis occur in infants too young to have received more
than 1 dose of pertussis-containing vaccine.18,28
The prevention of severe pertussis morbidity and deaths, particularly in infants
<3 months of age, is a major goal in Australia and similar countries. Two
vaccination strategies have been considered to achieve this indirect protection
from immunisation of household contacts and carers of newborn infants, known
as the cocoon strategy,29 and direct protection from immunisation of the mother
during the last trimester of pregnancy30 (refer to 4.12.4 Vaccines and 4.12.7
Recommendations below).
(Pertussis updated March 2015 ) PART 4 VACCINE-PREVENTABLE DISEASES 303
4.12 PERTUSSIS
infections.12,13 There have also been case reports documenting nosocomial

infection in young infants acquired from healthcare workers.14-17 Pertussis
hospitalisation rates for persons aged 60 years are higher than for other adults.18
4.12.4 Vaccines
Pertussis vaccine is only available in Australia in combination with diphtheria
and tetanus, with or without other antigens such as inactivated poliomyelitis,
hepatitis B and Haemophilus influenzae type b. The acronym DTPa, using capital
letters, signifies child formulations of diphtheria, tetanus and acellular pertussiscontaining vaccines. The acronym dTpa is used for formulations that contain
substantially lesser amounts of diphtheria toxoid and pertussis antigens than
child (DTPa-containing) formulations; dTpa vaccines are usually used in
adolescents and adults.
Acellular pertussis-containing vaccines have been used for both primary and
booster vaccination of children in Australia since 1999. Whole-cell pertussiscontaining vaccines were used exclusively before 1997. Between 1997 and 1999
acellular vaccines were used for booster doses. There are a number of acellular
pertussis-containing vaccines that contain two or more purified components
of B.pertussis. In the 2-component vaccine these are pertussis toxin (PT) and
filamentous haemagglutinin (FHA); in the 3-component vaccines, pertactin
(PRN) is also included; and in the 5-component vaccines, two fimbrial (FIM)
antigens are also included. In the last decade, 3-component vaccines have been
predominantly used in the childhood immunisation schedule in Australia.
Pertussis vaccines provide good protection against severe and typical pertussis,
but substantially less against milder coughing illness.31,32 Vaccine efficacy of
DTPa vaccines with three or more antigens has been reported as 71 to 78%
for preventing milder symptoms of pertussis and 84% for preventing typical
disease.32 Epidemiological data suggest that receipt of the 1st dose of the primary
DTPa course significantly reduces the incidence of severe pertussis disease in
young infants, as measured by hospitalisation rates.33-35 However, there is a
growing body of evidence that immunity following DTPa, and in turn vaccine
effectiveness, wanes over time. In Australia, the effectiveness of 3 doses of
pertussis-containing vaccine declined progressively from 2 years of age, to less
than 50% by 4 years of age, in children aged 13 years who had not received an
18-month booster dose.26 Likewise, studies in older children from both Australia
and the United States have shown a reduction in vaccine effectiveness associated
with time since the dose of DTPa given prior to starting school.23-25
Reduced antigen content formulation, dTpa, vaccines are immunogenic.36-39
A randomised trial in adults reported a point estimate of 92% efficacy against
culture/nucleic acid test-positive disease within 2.5 years of vaccination
with a 3-component monovalent pertussis vaccine.4 Data on the duration of
immunity to pertussis following a single booster dose of dTpa are limited. Longterm follow-up of adults vaccinated with dTpa has shown a rapid decline in
levels of pertussis antibodies within the first 2 years after vaccination, with a
continued steady decline out to 10 years after vaccination, although antibody
levels remained above baseline.40 A similar long-term follow-up of adolescents
demonstrated a more rapid decline, with pertussis antibody levels decreasing
Vaccination of pregnant women with dTpa has been shown to be effective in

preventing pertussis disease in newborn infants via the transfer of maternal
antibodies in utero. Vaccination of mothers at least 7 days before delivery
reduced pertussis disease by 91% in infants <3 months of age.42 However, the
level of pertussis antibody required in the pregnant woman to achieve this
level of protection and the impact of waning pertussis immunity in the mother
are not known. On the one hand, pertussis-specific IgG levels in maternal and
umbilical cord serum of mother-and-newborn pairs show significant antibody
decay over a 2-year interval between pregnancies.43 On the other hand, pertussis
antibody levels in the cord blood of infants whose mothers were vaccinated
approximately 13 months previously (following birth of an older sibling) were
significantly higher than those in cord blood of the older sibling prior to maternal
vaccination.44
Studies have shown lower levels of anti-pertussis antibodies at 7 months of age
in children born to women vaccinated with dTpa during pregnancy, compared
to children of mothers who were not vaccinated. However, when children were
given a booster dose of DTPa-containing vaccine at 1218 months of age, levels
of anti-pertussis antibodies 1month later were similar irrespective of whether the
childs mother was vaccinated during pregnancy or not.45,46
Cocoon vaccination is an alternative vaccination strategy expected to reduce
infection risk to infants, especially the youngest of infants, through the
vaccination of household contacts and carers who are known to be an important
source of pertussis infection (refer to 4.12.3 Epidemiology above).11 However, the
emerging data on the effectiveness of indirect protection to infants from the
cocoon approach suggest only a modest benefit.47

Infanrix GlaxoSmithKline (DTPa; diphtheria-tetanus-acellular
pertussis). Each 0.5mL monodose vial or pre-filled syringe contains
30IU diphtheria toxoid, 40IU tetanus toxoid, 25g pertussis toxoid
(PT), 25g filamentous haemagglutinin (FHA), 8g pertactin (PRN),
adsorbed onto 0.5mg aluminium as aluminium hydroxide.
toxoid, 25g PT, 25g FHA, 8g PRN, 10g recombinant HBsAg, 40
4.12 PERTUSSIS
to or approaching pre-vaccination levels after 10 years.41 The rate of decline in

clinical protection is unknown, but some protection against clinical disease may
persist for up to 10 years. Recent studies have indicated that dTpa vaccine is
immunogenic in the elderly.39
D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen

units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett), adsorbed
PT, 25g FHA, 8g PRN, 40 D-antigen units inactivated poliovirus
units type 3 (Saukett), adsorbed onto aluminium hydroxide; traces of
formaldehyde, polysorbate 80, polymyxin and neomycin.
and streptomycin.
neomycin.
toxoid, 40IU tetanus toxoid, 10g PT, 5g FHA, 3g PRN, 5g FIM
2+3; 1.5mg aluminium phosphate; 3.4mg phenoxyethanol.
Reduced antigen formulations for adults, adolescents and children aged 10 years
Adacel Polio Sanofi Pasteur Pty Ltd (dTpa-IPV; diphtheria-tetanusacellular pertussis-inactivated poliovirus). Each 0.5mL monodose
vial or pre-filled syringe contains 2IU diphtheria toxoid, 20IU
tetanus toxoid, 2.5g PT, 5g FHA, 3g PRN, 5g FIM 2+3, 40
D-antigen units inactivated poliovirus type 1 (Mahoney), 8 D-antigen
units type 2 (MEF-1) and 32 D-antigen units type 3 (Saukett); 0.33mg
aluminium as aluminium phosphate; phenoxyethanol; traces of
and streptomycin.
glycine.


The dose of all pertussis-containing vaccines is 0.5mL to be given by IM injection.
4.12 PERTUSSIS

phenoxyethanol; traces of formaldehyde and glutaraldehyde.
Do not mix DTPa- or dTpa-containing vaccines with any other vaccine in the
same syringe, unless specifically registered for use in this way.
Primary doses
Pertussis-containing vaccine is recommended in a 3-dose primary schedule for
infants at 2, 4 and 6 months of age. Due to the high morbidity and occasional
mortality associated with pertussis in the first few months of life, the 1st dose
can be given as early as 6 weeks of age (refer to Table 2.1.5 Minimum acceptable
age for the 1st dose of scheduled vaccines in infants in special circumstances). Giving a
1st dose at 6 weeks of age rather than 2 months of age is estimated to prevent an
additional 8% of infant pertussis cases. The next scheduled doses should still be
given at 4 months and 6 months of age.33,49
Booster doses
Two booster doses of pertussis-containing vaccine are recommended during
childhood to provide ongoing protection against pertussis through to early
adolescence (refer to Older children and adolescents below).
The first booster dose of pertussis-containing vaccine (dose 4 in the childhood
series), usually provided as DTPa, is recommended at 18 months of age. This
booster dose is required due to waning of pertussis immunity following receipt
of the primary schedule (refer to 4.12.4 Vaccines above).26
The second booster dose of pertussis-containing vaccine (dose 5 in the childhood
series), usually provided as DTPa-IPV, is recommended at 4 years of age.
This second booster dose is essential to maximise pertussis immunity during
childhood as waning occurs progressively with age.23,24
For details on the management of children who require catch-up vaccination for
pertussis, including minimum acceptable intervals between vaccine doses, refer
to 2.1.5 Catch-up.
In addition, household contacts and carers of infants should be age-appropriately
immunised to minimise the risk of severe disease occurring in young infants
prior to completion of the primary course (refer to Older children and
adolescents and Adults below).

An additional booster dose of pertussis-containing vaccine (i.e. in addition to
those recommended for young children, refer to above) is recommended for
adolescents between 10 and 17 years of age, using the reduced antigen content
dTpa. The optimal age for administering this dose is 1113 years, due to
waning of the antibody response following the booster dose recommended at
4 years of age.23,24 This adolescent booster dose of pertussis-containing vaccine
is essential for maintaining immunity to pertussis (and diphtheria and tetanus)
into adulthood.50
vaccination for pertussis, refer to 2.1.5 Catch-up.
Vaccination with dTpa is recommended for any adult who wishes to reduce the
likelihood of becoming ill with pertussis. Vaccination is particularly important
if the adult meets the criteria of a special risk group (refer to Persons in contact
with infants and others at increased risk from pertussis below).
dTpa vaccine should be used in place of dT at the age routinely recommended
for a tetanus and diphtheria booster (50 years). There is currently insufficient
evidence to recommend routine 10-yearly booster doses of dTpa vaccine for all
adults (who do not meet the criteria of a special risk group below). However,
due to the increased morbidity associated with pertussis in the elderly,18 adults
aged 65 years should be offered a single dTpa booster if they have not received
one in the previous 10 years.18,51 Adults of all ages who require a booster dose
of dT vaccine should be encouraged to do so with dTpa vaccine, particularly
if they have not received a dTpa dose previously (refer to 4.19 Tetanus and 4.2
Diphtheria).52
Travellers should receive a booster dose of dT (or dTpa if not given previously)
if more than 10 years have elapsed since the last dose of dT-containing vaccine.
of a dT-containing vaccine (refer to 4.19 Tetanus and 4.2 Diphtheria).
For those adults requiring additional protection from polio (refer to 4.14
Poliomyelitis), dTpa-IPV can be used.
or pertussis-containing vaccine requiring catch-up, refer to 4.19 Tetanus and 2.1.5
Catch-up.
Persons in contact with infants and others at increased risk from pertussis
There is significant morbidity associated with pertussis infection in infants <6
months of age, particularly those <3months of age,18 and the source of infection
in infants is often a household contact11 (also refer to 4.12.3 Epidemiology above).
Pertussis vaccination of the close contacts of young infants is likely to reduce the
risk of pertussis occurring in the infant and is recommended for the following
groups.
Women who are pregnant or post-partum
dTpa vaccine is recommended as a single dose during the third trimester of each
pregnancy (refer to 3.3 Groups with special vaccination requirements). Vaccination
during pregnancy has been shown to be more effective in reducing the risk of
pertussis in young infants than vaccination of the mother post partum.42,47 This
added benefit is due to direct passive protection of the newborn by transplacental
transfer of high levels of pertussis antibodies from the vaccinated woman
4.12 PERTUSSIS
Adults
to the fetus. As pertussis antibody levels do not peak until approximately 2

weeks after vaccination53 and active transport of maternal antibody to the fetus
occurs predominantly from 30 weeks gestation onwards,54 the optimal time for
vaccination is early in the third trimester (between 28 and 32 weeks). However,
the vaccine can be given at any time during the third trimester up to delivery.
Vaccination is recommended with each pregnancy to provide maximal protection
to every infant; this includes pregnancies which are closely spaced (e.g. <2 years).
Vaccine-induced pertussis antibodies wane over time and the protective antibody
level required in newborn infants is unknown (refer to 4.12.4 Vaccines above).
It is therefore possible that if a mother is not revaccinated during a subsequent
pregnancy (even if closely spaced), her newborn will not be adequately protected
against severe pertussis illness.
For any pregnancy where antenatal vaccination does not occur, vaccination
during the post-partum period, as soon as possible after delivery of the infant
(preferably before hospital discharge), will reduce the likelihood of pertussis
occurring in the mother and thus provide some indirect protection to the infant.47
Other adult household contacts and carers of infants <6 months of age
Adult household contacts and carers (e.g. fathers, grandparents) of infants

<6months of age should ideally receive a dTpa vaccine at least 2weeks before
beginning close contact with the infant. A booster dose of dTpa is recommended
if 10years have elapsed since a previous dose.40,41
Healthcare workers
All healthcare workers should receive dTpa vaccine because of the significant
risk of nosocomial transmission of pertussis to vulnerable patients.14-17 (also
refer to 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended
vaccinations for persons at increased risk of certain occupationally acquired vaccinepreventable diseases.) A booster dose of dTpa is recommended if 10years have
elapsed since a previous dose.40,41 Vaccinated healthcare workers who develop
symptoms compatible with pertussis should still be investigated for pertussis.
There have been cases of nosocomial transmission of pertussis to infants from
healthcare workers who have previously received dTpa vaccine.15
Staff working in early childhood education and care
Adults working with infants and young children aged <4 years should receive
dTpa vaccine (refer to 3.3 Groups with special vaccination requirements, Table
3.3.7 Recommended vaccinations for persons at increased risk of certain occupationally
acquired vaccine-preventable diseases). A booster dose of dTpa is recommended if
10years have elapsed since a previous dose.40,41
Interval between dTpa and other tetanus/diphtheria-containing vaccines

A single dose of dTpa can be administered at any time after a dose of a vaccine
containing tetanus and diphtheria toxoids. Studies indicate that the adverse
reactions to a single dose of dTpa are similar whether administered shortly after
Persons with a history of pertussis infection

Administration of pertussis vaccine in children, adolescents or adults who have
had laboratory-confirmed pertussis infection is safe and is necessary, as natural
immunity does not confer life-long protection. In particular, incompletely
vaccinated infants <6 months of age who develop pertussis may not mount an
adequate immune response following infection and should receive all routinely
scheduled pertussis-containing vaccines.

dTpa vaccine is recommended for pregnant women (in the third trimester of
each pregnancy) (refer to Women who are pregnant or post-partum in 4.12.7
dTpa vaccine can be given to breastfeeding women.
The only absolute contraindications to acellular pertussis-containing vaccines are:
anaphylaxis following a previous dose of any acellular pertussis-containing
vaccine

DTPa-containing vaccines in children
Acellular pertussis vaccines are associated with a much lower incidence of fever
(approximately 20%) and local adverse events (approximately 10%) than wholecell pertussis vaccines (approximately 45% and 40%, respectively), which are no
longer used in Australia.31,32,60
Extensive limb swelling, defined as swelling and/or redness involving at least
half the circumference of the limb and the joints both above and below the
injection site, is a recognised adverse event that occurs rarely following booster
doses of DTPa. Such reactions commence within 48 hours of vaccination, last
for 1 to 7 days and resolve completely without sequelae.61 The pathogenesis of
extensive limb swelling is poorly understood. In an analysis of 4th and 5th dose
follow-up studies that examined 12 different DTPa vaccines, 2% of 1015 children
who received consecutive doses of the same DTPa vaccine reported entire thigh
swelling, which resolved completely.61 A history of extensive limb swelling after
4.12 PERTUSSIS
(18 months), or at a longer interval after, a previous dose of a vaccine containing

tetanus/diphtheria toxoids.55-58 Where a tetanus- and diphtheria-containing
vaccine has been given less than 18 months previously, the benefits of protection
against pertussis gained from using dTpa, where recommended, are likely to
outweigh the risk of an adverse event.59
a booster dose of DTPa is not a contraindication to reduced antigen formulations

of dTpa at 1113 years of age (or older).62 Parents of children about to receive a
booster dose of a DTPa-containing vaccine should be informed of the small but
well-defined risk of this adverse event which, even when extensive, is usually
not associated with significant pain or limitation of movement.
Febrile convulsions are very infrequently reported following DTPa-containing
vaccines, within 48 hours of vaccination. The risk is even lower in infants who
complete their primary course at 6 months of age, as febrile convulsions are
uncommon in children <6 months of age. Children who experience a febrile
convulsion after a dose of DTPa-containing vaccine have a slightly greater risk
of a further febrile convulsion following a subsequent dose of a DTPa-containing
vaccine. This risk can be minimised by appropriate measures to prevent fever, so
vaccination is still recommended.
Hypotonic-hyporesponsive episodes (HHE), defined as an episode of pallor,
limpness and unresponsiveness, occur rarely following DTPa vaccine, 1 to 48
hours after vaccination. Shallow respiration and cyanosis may also occur in an
HHE. An HHE may last from a few minutes to 36 hours. In Australia during
2009, 3.2 cases of HHE were reported per 100000 doses of DTPa-containing
vaccine given to children <1 year of age.63 Follow-up of children with HHE
shows no long-term neurological or other sequelae and they can receive further
doses of DTPa-containing vaccines.64 Children who have an HHE following
DTPa-containing vaccines should receive further doses as recommended.
Supervision may be required under some circumstances; advice can be obtained
from clinics specialising in the management of adverse events following
immunisation (refer to Appendix 1 Contact details for Australian, state and territory
Pertussis-containing vaccines do not cause infantile spasms or epilepsy. Infants
and children known to have active or progressive neurological disease can be
safely vaccinated with DTPa-containing vaccines. A large Canadian study found
no evidence of encephalopathy following acellular pertussis vaccines.65 For
infants and children with stable neurological disease (including cerebral palsy),
or a family history of idiopathic epilepsy or other familial neurological disorder,
the risk of adverse events following DTPa-containing vaccines is the same as for
other infants of the same age.
Sudden infant death syndrome (SIDS) is not associated with either DTPa or any
pertussis-containing vaccine.66 Some studies suggest a decreased risk of SIDS in
children who have been vaccinated.67-69
dTpa-containing vaccines in adolescents and adults

Reduced antigen content dTpa vaccines are safe and well-tolerated in adults.36,70,71
The incidence of fever is low, and comparable in vaccine and placebo recipients
in clinical trials.36,70,71 Studies investigating revaccination within 10 years (and
Brachial neuritis (inflammation of a nerve in the arm, causing weakness or

numbness) has been described following the administration of tetanus toxoidcontaining vaccines, with an estimated excess risk of approximately 0.51 in
100000 doses in adults.73,74
dTpa vaccines in pregnant women

Studies have found no evidence of an increased risk of adverse pregnancy
outcomes (such as stillbirth, pre-eclampsia, fetal distress, low birth weight or
neonatal renal failure) related to pertussis vaccination during pregnancy.45,75-79
While dTpa vaccine is generally safe and well-tolerated in adults, there is a small
risk that significant injection site reactions following subsequent doses might
occur in some women who receive dTpa vaccines during successive closely
spaced pregnancies. This low risk is considered to be balanced by the benefit to
each infant of protection against pertussis.
4.12.11 Public health management of pertussis

Pertussis (both suspected and confirmed) is a notifiable disease in all states and
territories in Australia. Detailed information regarding case definitions and
the management of pertussis cases and contacts can be found in the national
guidelines for control of pertussis80 (www.health.gov.au/cdnasongs).
Further instructions about the public health management of pertussis can also
be obtained from state/territory public health authorities (refer to Appendix 1
Suspected cases of pertussis should be investigated, regardless of vaccination
status, as immunisation is not 100% effective and immunity wanes over time. The
diagnosis of pertussis can be confirmed by either culture or nucleic acid testing
of a per-nasal swab or nasopharyngeal aspirate specimen, or by serology. The
appropriate diagnostic test depends on the age, vaccination history and duration
of symptoms. PCR is usually the diagnostic method of choice, particularly if
pertussis is suspected in someone who has received a pertussis-containing
vaccine within the previous 5 years.81
To reduce the risk of transmission of B. pertussis, persons with pertussis infection
should commence appropriate antibiotic therapy on clinical suspicion, if within
4.12 PERTUSSIS
some within 2 years) after a tetanus toxoid-, dT- or dTpa-containing vaccine

in non-pregnant adolescents and adults have found no increase in moderate
or severe adverse events or subjective fever. However, an increase in mild
transient injection site pain is often reported following dTpa-containing booster
doses.40,57,58,72 Limb swelling reactions after dTpa-containing booster doses are
rare.40,41,72 In adults who report a history of adverse event(s) following whole-cell
pertussis-containing vaccine given in childhood, dTpa can almost always be
given (refer to 3.3.1 Vaccination of persons who have had an adverse event following
immunisation).
21 days of the onset of coryza. Antibiotic treatment does not shorten the course
of the illness, but reduces infectivity if provided early in the illness. Detailed
information regarding appropriate macrolide antibiotics and dosing can be found
in the national guidelines for control of pertussis.80,82
Management of contacts of cases

Vaccination
Since a primary vaccination course requires three or more injections to protect
against pertussis, infant vaccination cannot be effectively used to protect
unimmunised infants. Vaccination has not been shown to have a role in
controlling outbreaks at any age, even in closed settings. However, unvaccinated
or partially vaccinated contacts, up to their 10th birthday, should be offered
DTPa-containing vaccines, and older contacts should be offered dTpa (refer to
2.1.5 Catch-up).
Passive immunisation with normal human immunoglobulin is not effective in the
prevention of pertussis.
Chemoprophylaxis
The benefit of chemoprophylaxis in preventing the secondary transmission
of pertussis is limited due to multiple factors, including delayed clinical
presentation, delayed diagnosis and imperfect compliance.83 The use of
chemoprophylaxis for prevention of secondary cases should be limited
to high-risk close contacts of cases. Further recommendations regarding
chemoprophylaxis of close contacts can be found in the national guidelines for
control of pertussis.80

The product information for Infanrix states that this vaccine is indicated for
primary immunisation of infants from the age of 2 months to 12 months and
as a booster dose for children from 15 months to 6 years of age who have
previously been vaccinated against diphtheria, tetanus and pertussis. The
ATAGI recommends that this vaccine may also be used for catch-up of the
primary schedule or as a booster in children <10 years of age. The ATAGI also
recommends that the primary schedule may be commenced at 6 weeks of age, if
required.
for use in a 3-dose primary schedule for immunisation of infants from the age
of 6 weeks and as a single booster dose for children 6 years of age who have
previously been vaccinated against diphtheria, tetanus, pertussis and poliomyelitis.
In addition, the ATAGI recommends that this product may also be used for catchup of the primary schedule or as a booster in children <10 years of age.
The product information for Adacel states that vaccination in pregnancy is not
recommended unless there is a definite risk of acquiring pertussis. The product
information for Boostrix states that the vaccine should be used during pregnancy
only when clearly needed, and the possible advantages outweigh the possible
risks for the fetus. The ATAGI recommends that pregnant women receive a dose
with every pregnancy.
The product information for Adacel and Boostrix state that there is no
pertussis in adults. However, the ATAGI recommends that pregnant or postpartum women receive a booster dose with every pregnancy and that other
4.12 PERTUSSIS
adults in contact with infants and/or at increased risk from pertussis can receive
a booster dose every 10 years.
The product information for Adacel, Adacel Polio, Boostrix, Boostrix-IPV,
Infanrix, Infanrix hexa, Infanrix IPV, Pediacel, Quadracel and Tripacel states that
these vaccines are contraindicated in children with encephalopathy of unknown
aetiology or with neurologic complications occurring within 7 days following a
vaccine dose. The ATAGI recommends instead that the only contraindication is a
history of anaphylaxis to a previous dose or to any of the vaccine components.
References
4.13.1 Bacteriology
Streptococcus pneumoniae (pneumococcus) is a Gram-positive coccus. The
polysaccharide capsule is the most important virulence factor of pneumococci.1,2
Over 90 capsular antigenic types (serotypes) have been recognised, each of which
elicits type-specific immunity in the host.3,4 The natural reservoir of pneumococci
is the mucosal surface of the upper respiratory tract of humans.1,3 In a large
majority of hosts, pneumococci are carried with no apparent symptoms. Different
pneumococcal serotypes vary in their propensity to cause nasopharyngeal
colonisation or disease. Worldwide, only a limited number of serotypes are
responsible for most cases of invasive pneumococcal disease (IPD) but the
predominant serotypes vary by age group and geographic area.5,6 Antibiotic
resistance in pneumococci is an increasing challenge; in 2006, 11% of Australian
IPD isolates were non-susceptible to penicillin and 3% were non-susceptible to
ceftriaxone/cefotaxime.7

Person-to-person transmission of S.pneumoniae occurs via contact with
respiratory droplets of colonised persons. Almost all pneumococcal disease
probably begins with the establishment of nasopharyngeal colonisation. From
the nasopharynx, pneumococci may spread locally into adjacent sites to cause
sinusitis, otitis media or pneumonia. Pneumococci may enter the bloodstream,
and also localise in the meninges, causing meningitis, or at other sites including
bones, joints and soft tissues.1-3,5 For disease surveillance purposes, detection
of S.pneumoniae in a normally sterile site, such as blood, cerebrospinal fluid
or pleural fluid, by culture or nucleic acid testing, is classified as IPD. The
major clinical categories of IPD are meningitis, bacteraemic pneumonia, and
bacteraemia without focus. In adults, pneumonia with bacteraemia is the most
common manifestation of IPD. Although more difficult to measure for nonbacteraemic cases, it is estimated that pneumococci account for over one-third of
all community-acquired pneumonia and up to half of hospitalised pneumonia
in adults.2,8 In children, the most common manifestation is bacteraemia without
focus, accounting for approximately 70% of IPD, followed by pneumonia with
bacteraemia. Meningitis, although least common, is the most severe category of
IPD and has an estimated case-fatality rate of about 30%.1,2 Acute otitis media
(AOM) is the most common non-invasive manifestation of pneumococcal disease
in children. S.pneumoniae is detected in 28 to 55% of middle ear aspirates from
children with AOM.2,5,9
Immunocompromised persons who are unable to mount an adequate immune
response to pneumococcal capsular antigens, including those with asplenia,
have the highest risk of IPD.1,2,4 Household crowding, exposure to cigarette
smoke, childcare attendance, excessive alcohol consumption and certain nonimmunocompromising chronic medical conditions are also associated with
4.13 PNEUMOCOCCAL DISEASE
greater risk and/or severity of IPD.1,2,10,11 Indigenous populations in developed

countries, including Aboriginal and Torres Strait Islander people in Australia,
have a disproportionately high burden of IPD.1,12,13
4.13.3 Epidemiology
The highest incidence of IPD is seen at the extremes of age, in young children
and the elderly.5,7 In Australia, vaccination with 7-valent pneumococcal
conjugate vaccine (7vPCV) was first funded under the NIP from mid-2001, to
5 years of age for Indigenous children living in Central Australia and children
with specified predisposing medical conditions, and to 2 years of age for nonIndigenous children living in Central Australia and Indigenous children in the
rest of the country. One dose of the 23-valent pneumococcal polysaccharide
vaccine (23vPPV) at 1824 months of age, as a booster following a primary
7vPCV schedule, was also funded for Indigenous children without predisposing
medical conditions living in jurisdictions with the highest incidence of IPD (the
Northern Territory, Queensland, South Australia and Western Australia). From
January 2005, NIP-funded 7vPCV was extended to all infants nationally, together
with catch-up vaccination for all children aged <2 years. High vaccination
uptake of over 90% has been maintained since the inception of universal infant
pneumococcal vaccination.
The introduction of 7vPCV led to a dramatic reduction in the overall incidence
of IPD in Australia, which was greatest in the primary target group of children
<2 years of age and for IPD caused by the seven vaccine serotypes. Among
non-Indigenous children <2 years of age, the overall notification rate of IPD
declined by 75%, from 78 per 100 000 in the pre-vaccination period (20022004)
to 19.5 per 100 000 in the post-vaccination period (2007); IPD due to 7vPCV
serotypes decreased by 97%, from 60.9 to 2.1 per 100 000, respectively.14,15 There
was also a marked reduction in pneumonia hospitalisations, presumed to be
attributable to 7vPCV vaccination, in children <2 and 24 years of age (of 38%
and 28%, respectively).16 Reductions in IPD were also observed in age groups
not targeted for vaccination (herd immunity effect); the incidence of IPD due
to 7vPCV serotypes declined by between 50 and 60% in various age groups
>5 years of age.14
Although 7vPCV use resulted in a marked reduction in rates of IPD due to
vaccine serotypes, IPD among Indigenous children remains disproportionately
higher than in non-Indigenous children, due to significantly higher rates of IPD
caused by non-7vPCV serotypes.7,15,17 (See also 3.1 Vaccination for Aboriginal and
Torres Strait Islander people.)
Serotype distribution of pneumococcal disease is more diverse in adults than in
children, and more diverse in Aboriginal and Torres Strait Islanders than in other
Australians. Prior to universal infant vaccination, 85% of IPD in children aged
<2 years was caused by the seven vaccine serotypes;18 however, the proportion
differed substantially between Indigenous children (46%) and
Vaccination using 23vPPV was introduced in 1999 for all Indigenous adults aged
50 years and younger Indigenous adults with risk factors. Since January 2005,
23vPPV has also been funded under the NIP for non-Indigenous adults aged
65 years. Persons aged <65 years with a condition(s) associated with an
increased risk of IPD can access 23vPPV through the Pharmaceutical Benefits
Scheme. Most IPD isolates in adults belong to serotypes contained in 23vPPV.7,21
In non-Indigenous adults, the prevalence of risk factors among those with
IPD increases with age. In contrast, among Indigenous adults, there is a high
prevalence of risk factors in IPD cases of all ages.21 Overall, among adults aged
65 years, the incidence of IPD was 29% lower in 20062007 than in 20022004.
This was mostly due to a 53% decrease in the incidence of serotypes included in
7vPCV, despite increases in IPD caused by serotypes both included in (46%) and
not included in (57%) 23vPPV.14
The impact of 23vPPV on rates of IPD in Indigenous adults has varied in
different geographical areas and, at a national level, disparities remain in disease
rates between Indigenous and non-Indigenous adults. As is the case for influenza
and pneumonia, rates of IPD are highest in older Indigenous adults (see 3.1
Vaccination for Aboriginal and Torres Strait Islander people).
4.13.4 Vaccines
There are two different types of pneumococcal vaccines pneumococcal
conjugate vaccine (PCV) and pneumococcal polysaccharide vaccine (PPV).
Among the pneumococcal conjugate vaccines, formulations vary in the
number of pneumococcal serotypes included and the conjugating proteins
used. Pneumococcal conjugate vaccines are immunogenic in young infants
and can induce an immune memory response. In contrast, 23vPPV is poorly
immunogenic for most serotypes in children aged <2 years and does not induce
immune memory; however, 23vPPV contains more serotypes.
non-Indigenous children (88%).19,20 Since the implementation of the universal

7vPCV program, increased rates of IPD caused by certain serotypes not
contained in 7vPCV (replacement disease) have been observed in Australia and
several other countries. This is particularly so among non-Indigenous children
aged <2 years, in whom 44% of IPD in 2007 was due to serotype 19A.15 In 2009
and 2010, two extended-valency pneumococcal conjugate vaccines (the 10-valent
[10vPCV] and the 13-valent [13vPCV], respectively) became available in
Australia. In the Northern Territory, 10vPCV replaced 7vPCV from October 2009.
In other jurisdictions, 13vPCV (which includes serotype 19A) replaced 7vPCV
under the NIP for infants in July 2011, and in the Northern Territory replaced
10vPCV from September 2011.
Pneumococcal conjugate vaccines

Synflorix GlaxoSmithKline (10-valent pneumococcal conjugate
vaccine; 10vPCV). Each 0.5mL monodose vial or pre-filled syringe
contains 1g of pneumococcal capsular polysaccharide of serotypes
1, 5, 6B, 7F, 9V, 14, 23F and 3g of serotype 4, conjugated to a total of
916g of non-typeable H.influenzae protein D, 3g of serotype 18C
conjugated to 510g of tetanus toxoid carrier protein, and 3g of
serotype 19F conjugated to 36g of diphtheria toxoid carrier protein,
adsorbed onto 0.5mg aluminium as aluminium phosphate.
Prevenar 13 Pfizer Australia Pty Ltd (13-valent pneumococcal
conjugate vaccine; 13vPCV). Each 0.5mL monodose pre-filled syringe
contains 2.2g each of pneumococcal capsular polysaccharide of
serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F and 4.4g of
serotype 6B, conjugated to non-toxic Corynebacterium diphtheriae
CRM197 protein, adsorbed onto 0.565mg aluminium phosphate;
succinic acid; polysorbate 80.
7-valent pneumococcal conjugate vaccine (7vPCV)
A 7vPCV with the mutant non-toxic diphtheria CRM197 protein as the conjugating
protein (Prevenar) became available in Australia in 2001. Efficacy data on the
7vPCV from a pivotal trial in the United States found greater than 95% protective
efficacy against IPD caused by the serotypes contained in the vaccine.22 A
Cochrane review of clinical trials estimated an efficacy of 80% against vaccinetype IPD for PCVs (most, but not all, of which used CRM197 as the conjugating
protein) in children <2 years of age.23 Based on the included studies, the
effectiveness against IPD of any serotype among these children was 58%,23 noting
that the proportion of IPD due to vaccine serotypes varies among different
populations. Effectiveness against X-ray confirmed pneumonia (using World
Health Organization [WHO] criteria) was lower, at 27%.
A 3-dose primary vaccination schedule for 7vPCV consisting of doses at 2, 4
and 6 months of age without a booster in the 2nd year of life was recommended
in Australia from 2001 (except for persons at increased risk of IPD). This
recommendation was initially based on data suggesting similar efficacy against
type-specific IPD with either 3 or 4 doses.22 Subsequent Australian data have
shown similar degrees of direct and indirect reduction in IPD and pneumonia
hospitalisations as those seen in countries with alternate schedules.24-27
7vPCV is no longer available, having been replaced in 2011 by 13vPCV made by
the same manufacturer.
10vPCV has been registered for use in Australia since 2009 and is included under
the NIP. The protein D of non-typeable H.influenzae (NTHi) is one of the main
conjugating proteins in this vaccine. This vaccine was used for all children aged
<2 years in the Northern Territory from October 2009 to September 2011, after
which 13vPCV has been used. (See also 3.1 Vaccination for Aboriginal and Torres
Strait Islander people.)
Clinical trials on 10vPCV with efficacy outcomes are not yet published;
registration of 10vPCV in Australia was based on immunogenicity data.28-32
A clinical study of a prototype 11-valent pneumococcal vaccine (containing
the 10 serotypes in 10vPCV plus serotype 3), also conjugated to NTHi protein
D, showed significant protective efficacy of approximately 58% against acute
otitis media caused by vaccine serotypes (as well as protective efficacy of
approximately 36% against AOM caused by H.influenzae).33 10vPCV has been
shown to produce robust antibody responses to all 10 serotypes contained
in the vaccine after a 4th (booster) dose in the 2nd year of life, but lesser
antibody responses after 3 primary doses given in infancy.31,32 Although
10vPCV does not contain specific antigens for serotypes 6A or 19A, there were
also measurable levels of antibody against these cross-reacting serotypes in
functional antibody assays.31,32
13vPCV has been registered in Australia since 2010, and used in the NIP
since July 2011. A single supplementary dose of 13vPCV for children aged
1235 months who completed primary vaccination with 7vPCV was available
under the NIP for 12 months from October 2011.
Registration of 13vPCV was based on immunogenicity studies showing noninferiority for the 7vPCV serotypes and comparable antibody response to the
additional serotypes.34-39 This includes serotype 19A, for which high levels of
functional antibody have been demonstrated. Early data from 13vPCV use in
England and Wales in 2011 have shown an impact against IPD caused by the
additional serotypes contained in the vaccine.40
Based on the substantial impact of the 7vPCV program on serotype-specific
IPD, the similar composition of 13vPCV and 7vPCV, and immunogenicity data,
a 2, 4, 6 month schedule without a booster is also recommended for 13vPCV
(except for those with a medical condition(s) associated with an increased risk of
IPD or Indigenous children living in high-incidence regions). The comparative
effectiveness of this schedule will continue to be monitored.
13vPCV has also been registered since October 2011 for use in adults aged
50 years, based on immunogenicity data showing equivalent or better antibody
responses than those provided by 23vPPV for the shared vaccine serotypes. There
are currently no data on clinical outcomes for 13vPCV, but a study examining its
efficacy against pneumonia in adults is underway.41 In the absence of evidence
of superior effectiveness against IPD or non-IPD pneumonia, the relative benefit

of 13vPCV over 23vPPV for adults is uncertain, since the serotype coverage of
13vPCV is more limited. It is also uncertain whether the level of reduction in
IPD due to the additional serotypes contained in 13vPCV among adults (herd
immunity effect) will be similar to that seen following widespread use of 7vPCV
in children.
Pneumococcal polysaccharide vaccine

Pneumovax 23 CSL Limited/Merck & Co Inc (23-valent
pneumococcal polysaccharide vaccine; 23vPPV). Each 0.5mL
monodose vial contains 25g each of pneumococcal capsular
polysaccharide of serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A,
12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F; 0.25% phenol.
23vPPV contains polysaccharides derived from the 23 most frequent or most

virulent capsular types of S.pneumoniae isolated from sterile fluids in the United
States in the 1970s/early 1980s, with worldwide serotype distribution and
potential cross-reactive serotypes also taken into consideration.42 These serotypes
are responsible for most IPD cases in adults in Australia. 23vPPV induces
significant immune responses in immunocompetent adults, including the elderly,
with no substantial differences in immune response between older and younger
subjects, but poor responses in the immunocompromised.43 In children <2 years
of age, the antibody response is limited to a small number of serotypes without
previous 7vPCV vaccination.44
The latest published Cochrane review in 2008 found an estimated overall
protective efficacy of 74% for pneumococcal polysaccharide vaccines against
IPD, based on randomised controlled trials (RCTs). The review also found a
vaccine effectiveness of 52% against IPD in older adults or adults with conditions
associated with an increased risk of IPD, based on observational studies, but
lower efficacy against all-cause pneumonia, based on RCTs (29%).45 Evidence
from more recent controlled trials and observational studies using 23vPPV in the
elderly population is similar.46-52 Recent data from England and Wales reported
23vPPV vaccine effectiveness of 48% against IPD within 2 years of vaccination for
adults aged 65 years, but effectiveness waned and became insignificant beyond
5 years. In the subset of adults aged 6574 years with no risk factors, 23vPPV
effectiveness was higher (65% within 2 years) and was maintained for longer.53 In
Victoria, 23vPPV vaccine effectiveness was estimated to be 71% for adults aged
>65 years.54
There are no studies on the effectiveness of revaccination with 23vPPV for
disease endpoints, although significant and sustained antibody responses
after revaccination are seen in adults, including the elderly.55-59 Evidence of

10vPCV should be protected from light.

The dose of pneumococcal conjugate vaccines (10vPCV, 13vPCV) is 0.5mL, to
be given by IM injection, in the opposite limb to other injectable vaccines, if
possible.
The dose of pneumococcal polysaccharide vaccine (23vPPV) is 0.5mL, to be
given by either IM or SC injection, in the opposite limb to other injectable
vaccines, if possible. The IM route is preferred, as a 3-fold greater rate of injection
site reactions is found following administration of 23vPPV by the SC route.62
However, a vaccine dose administered subcutaneously does not need to be
repeated.
10vPCV (Synflorix) is registered for use in infants and children aged
6 weeks up to 5 years.
13vPCV (Prevenar 13) is registered for use in infants and children aged
6 weeks up to 17 years and adults aged 50 years.
23vPPV (Pneumovax 23) is registered for use in children aged 2 years
and in adults.

10vPCV may be concurrently administered with other vaccines routinely
used in the infant schedule.
13vPCV may be concurrently administered with other vaccines in the infant
schedule, including inactivated trivalent influenza vaccine. However, parents/
carers of infants or children who are recommended to receive both influenza
vaccine and 13vPCV should be advised of the increased risk of fever following
concomitant administration of these vaccines (see 4.13.10 Precautions below).
Simultaneous administration of Zostavax with pneumococcal polysaccharide
vaccine is not routinely recommended; if possible, the two vaccines should
be given at least 4 weeks apart. However, inadvertent administration of
Zostavax and pneumococcal polysaccharide vaccine at the same time or at an
interval of less than 4 weeks does not require revaccination. One clinical trial
showed reduced immunogenicity of Zostavax in subjects who received both
vaccines concomitantly, compared with those who received Zostavax alone; the
immunogenicity of 23vPPV was not affected by concurrent administration.63
lesser antibody responses to 2nd or subsequent doses of 23vPPV in adults is

variable,55-58,60 and, even if present, its correlation with clinical effectiveness is
unknown.
However, an observational study from the United States suggests this may not
impact on Zostavax effectiveness.64-66 (See also 4.24 Zoster.)
Interchangeability of 10vPCV and 13vPCV

There are no available specific data on the interchangeability of 10vPCV and
13vPCV. Although completion of a primary course of pneumococcal conjugate
vaccine with the same formulation is generally preferred, if vaccination with
10vPCV is commenced (e.g. in children born overseas), completion of the course
with 13vPCV is acceptable.
All children are recommended to receive a complete course of pneumococcal
conjugate vaccination. The total number of doses recommended depends on the
vaccine type used, on whether the child has a medical condition(s) associated
with an increased risk of IPD (see List 4.13.1), on the childs Indigenous status
and on whether the child is living in a jurisdiction with a high incidence of IPD
(the Northern Territory, Queensland, South Australia or Western Australia).
If 10vPCV is used for primary vaccination in infants, a total of 4 doses are
recommended, regardless of the childs Indigenous status or place of residence,
or whether the child has any underlying medical condition(s) associated with an
increased risk of IPD. The recommended schedule is 3 primary doses, at 2, 4 and
6 months of age, followed by 1 booster dose at between 12 and 18 months of age
(at least 6 months after the 3rd primary dose) (a 3+1 schedule).
If 13vPCV is used for primary vaccination in infants, the total recommended
schedule for most children is 3 primary doses, at 2, 4 and 6 months of age (a
3+0 schedule); however, additional doses are required for some children, as
summarised in Table 4.13.1. A booster dose of 13vPCV is recommended for
young Indigenous children living in the four jurisdictions specified above. In
these children, the risk of IPD is comparable to the risk of IPD in children with
certain medical conditions (see List 4.13.1).
The 1st dose of pneumococcal conjugate vaccine can be given as early as 6 weeks
of age. If the 1st dose is given at 6 weeks of age, the next scheduled doses should
still be given at 4 months and 6 months of age.
Recommended age for pneumococcal vaccine doses

2
4
6
12
1218
45
months* months months months months
years
Children without any medical conditions associated with an increased risk of
invasive pneumococcal disease (IPD)
If 10vPCV is used for the primary course:
All children
10vPCV 10vPCV 10vPCV
10vPCV
If 13vPCV is used for the primary course:

Non-Indigenous
children and
Indigenous children 13vPCV 13vPCV 13vPCV
in ACT, NSW, Tas

or Vic
Indigenous children 13vPCV 13vPCV 13vPCV
13vPCV
in NT, Qld, SA or WA
Children with a medical condition(s) associated with an increased risk of IPD
All children
13vPCV 13vPCV 13vPCV 13vPCV
23vPPV
* The 1st dose can be given as early as 6 weeks of age; the next scheduled doses should still be
given at 4 months and 6 months of age.
Only one booster dose of 13vPCV is required in the 2nd year of life, even if a child is both
Indigenous, living in the Northern Territory, Queensland, South Australia or Western Australia,
and also has one or more medical conditions associated with an increased risk of IPD.
Refer to List 4.13.1, Categories A and B, for medical conditions associated with an increased risk
of IPD in children.
The booster dose is due at 12 months of age, or later, depending on when the medical condition
is diagnosed; see also 2.1.5 Catch-up, Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and
23vPPV (Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD,
presenting at age <2 years.
For children aged 723 months who have not completed a full course of
pneumococcal conjugate vaccines, the timing and number of further doses for
catch-up vaccination depends on age and previous doses administered. For
recommendations, see the following three tables in 2.1.5 Catch-up:
Table 2.1.9 Catch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous
children, and Indigenous children residing in the Australian Capital Territory, New
South Wales, Tasmania and Victoria, who do not have any medical condition(s)
associated with an increased risk of invasive pneumococcal disease (IPD), aged
<5 years
Table 2.1.10 Catch-up schedule for 13vPCV (Prevenar 13) for Indigenous children
residing in the Northern Territory, Queensland, South Australia or Western
Australia ONLY, who do not have any medical condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD), aged <5 years
Table 4.13.1: R
ecommendations for pneumococcal vaccination for children
aged <5 years
Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV
(Pneumovax 23) in children with a medical condition(s) associated with an increased
risk of IPD, presenting at age <2 years (for children aged 723 months with a
medical condition(s) associated with an increased risk of IPD who have not
completed a full course of pneumococcal conjugate vaccines).
If catch-up is required in a child who has commenced vaccination with 10vPCV,
subsequent doses should be with 13vPCV. If 13vPCV is not available, 10vPCV
may be used, and catch-up vaccination should be provided according to the rules
in Table 2.1.10.
List 4.13.1: Conditions associated with an increased risk of invasive
pneumococcal disease (IPD) in children and adults, by severity
of risk*

Category A: Conditions associated with the highest increased risk of IPD
functional or anatomical asplenia, including:

sickle cell disease or other haemoglobinopathies
congenital or acquired asplenia (e.g. splenectomy), splenic dysfunction
immunocompromising conditions, including:
congenital or acquired immune deficiency, including symptomatic IgG
subclass or isolated IgA deficiency (Note: children who require monthly
immunoglobulin infusion are unlikely to benefit from vaccination)
immunosuppressive therapy (including corticosteroid therapy 2mg/kg
per day of prednisolone or equivalent for more than 1 week) or radiation
therapy, where there is sufficient immune reconstitution for vaccine
response to be expected
haematological and other malignancies
solid organ transplant
haematopoietic stem cell transplant (HSCT)
HIV infection (including AIDS)
chronic renal failure, or relapsing or persistent nephrotic syndrome
proven or presumptive cerebrospinal fluid (CSF) leak
cochlear implants
intracranial shunts
Category B: Conditions associated with an increased risk of IPD
chronic cardiac disease

particularly cyanotic heart disease or cardiac failure in children
excluding hypertension only (in adults)
chronic lung disease, including:
chronic lung disease in preterm infants
cystic fibrosis
severe asthma in adults (requiring frequent hospital visits and use of
multiple medications)
diabetes mellitus
Down syndrome
alcoholism
chronic liver disease
preterm birth at <28 weeks gestation
tobacco smoking
* See also 3.3.3 Vaccination of immunocompromised persons for more recommendations for
immunocompromised persons, including more specific revaccination recommendations for
haematopoietic stem cell transplant recipients.
Recommendations for pneumococcal vaccination differ for those aged >5 years (but not for
those aged <5 years) between categories in this table, i.e. depending on whether the person is
in Category A: Conditions associated with the highest increased risk of IPD or Category B:
Conditions associated with an increased risk of IPD. See also relevant sections below.
HSCT recipients require 3 doses of 13vPCV post transplantation, followed by 23vPPV,
irrespective of previous vaccine doses received (see Table 3.3.3 Recommendations for revaccination
following HSCT in children and adults, irrespective of previous immunisation history).
All infants born at <28 weeks gestation should receive vaccines recommended for those up to age
5 years with a medical condition(s) associated with an increased risk of IPD, according to Table
4.13.1. Thereafter, they only require further pneumococcal vaccine doses if they have chronic
lung disease, and/or other chronic medical conditions as specified above.
Tobacco smoking is not a medical condition, but is associated with an increased risk of IPD.
Children aged 25 years

Children aged 25 years who do not have a medical condition associated with
an increased risk of IPD are not routinely recommended to receive further
pneumococcal vaccine doses. If they have not previously received any PCV
doses, or had only 1 dose of a pneumococcal conjugate vaccine before 12 months
of age, a single dose of 13vPCV is recommended (see 2.1.5 Catch-up, Table
2.1.9 Catch-up schedule for 13vPCV (Prevenar 13) for non-Indigenous children, and
Indigenous children residing in the Australian Capital Territory, New South Wales,
Tasmania and Victoria, who do not have any medical condition(s) associated with an
increased risk of IPD, aged <5 years and Table 2.1.10 Catch-up schedule for 13vPCV
(Prevenar 13) for Indigenous children residing in the Northern Territory, Queensland,
South Australia or Western Australia ONLY, who do not have any medical condition(s)
associated with an increased risk of IPD, aged <5 years).
Children who have a medical condition(s) associated with an increased risk
of IPD, as described in List 4.13.1 (Categories A and B), should receive a
dose of 23vPPV at 45 years of age. Table 4.13.2 indicates which vaccines are
recommended, depending on prior vaccination history. The need for additional
doses of pneumococcal vaccine is based on the continuing higher susceptibility
of these children to IPD at older ages, and extrapolation from data showing that
boosting of immune responses to certain 7vPCV serotypes occurs when a dose of
23vPPV follows a prior 7vPCV dose(s).63,67-70 Recommendations for children with
a medical condition(s) associated with an increased risk of IPD (Categories A and
B) are the same regardless of Indigenous status or jurisdiction of residence.
A minimum interval of 2 months between the last dose of 13vPCV and 23PPV
is recommended, based on a small number of studies among children of
different ages with underlying conditions, which have shown that 23vPPV is
immunogenic if given approximately 2 months after a 7vPCV dose.71-74
Table 4.13.2: R
ecommendations for pneumococcal vaccination for children
aged 25 years with a medical condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD) (see List
4.13.1, Categories A and B)*
Vaccination history
Primary course of Supplementary/
any pneumococcal booster dose of
conjugate vaccine 13vPCV (at age 12
months)
Completed
Received
Completed
Not received
Not completed
Not received
Recommendations
Number of further
13vPCV dose(s)
required for children
aged 25 years
0
1
2
Single 23vPPV
dose required at
age 45 years
Yes
Yes
Yes
* HSCT recipients require 3 doses of 13vPCV post transplantation, followed by 23vPPV,

irrespective of previous vaccine doses received (see Table 3.3.3 Recommendations for revaccination
following HSCT in children and adults, irrespective of previous immunisation history).
See also 2.1.5 Catch-up, Table 2.1.11 Catch-up schedule for 13vPCV (Prevenar 13) and 23vPPV
(Pneumovax 23) in children with a medical condition(s) associated with an increased risk of IPD,
presenting at age <2 years. Note: this table primarily refers to 13vPCV, but could apply to use of
10vPCV if the former was not available.
At least 2 months after the last dose of PCV, whichever is later.
Minimum interval between the 2 doses should be 2 months.
Pneumococcal vaccine is not recommended for children in this age group who
do not have a medical condition(s) associated with an increased risk of IPD (see
List 4.13.1). The exception is in older Indigenous children (aged >15 years) who
have an increased risk of IPD, especially in the Northern Territory, where a dose
of 23vPPV is provided to all Indigenous adolescents at approximately 15 years of
age, based on the very high prevalence of conditions associated with an increased
risk of IPD and incidence of IPD in this sub-population (see Adults aged
18 years below and 3.1 Vaccination for Aboriginal and Torres Strait Islander people).
For children with a medical condition(s) associated with an increased risk of
IPD, further pneumococcal vaccine doses are recommended, as discussed below,
depending on the childs level of risk.
Those with the highest increased risk of IPD (List 4.13.1, Category A)
Children aged >5 to <18 years with a pre-existing chronic medical condition(s)
associated with the highest increased risk of IPD (List 4.13.1, Category A), who
were previously vaccinated according to the recommendations in Table 4.13.2,
should receive another 23vPPV dose 5 years after their 1st 23vPPV dose, at
approximately 10 years of age. Their next 23vPPV dose should be approximately
10 years later, at age 1820 years. (See also Adults with a condition(s) associated
with an increased risk of IPD below.) If a child in this category has never
received a dose of 13vPCV previously, 1 dose of 13vPCV should be administered,
with the exception of HSCT recipients who should receive 3 doses of 13vPCV
(see Table 3.3.3 Recommendations for revaccination following HSCT in children and
adults, irrespective of previous immunisation history). This should then be followed
by 23vPPV approximately 2 months later (if no prior 23vPPV dose has been
received), or a minimum of 5 years after a prior 23vPPV dose (see above). The
minimum interval between a previous 23vPPV dose and the single 13vPCV dose,
if required, is 12 months.
Children in this age group with a newly identified medical condition(s) associated
with the highest increased risk of IPD (List 4.13.1, Category A) are recommended
to receive a dose of 23vPPV at diagnosis. If they have not previously received a
dose of 13vPCV, they should receive one 13vPCV dose at diagnosis, followed by
their 1st 23vPPV dose a minimum of 2 months later. A further dose of 23vPPV
is recommended 5 years after the 1st 23vPPV dose (minimum 2 months after
13vPCV). Their next 23vPPV dose should be approximately 10 years later, or at
age 1820 years, whichever is later (see Adults with a condition(s) associated
with an increased risk of IPD below).
Those with an increased risk of IPD (List 4.13.1, Category B)
Children aged >5 to <18 years with a pre-existing medical condition(s) associated
with an increased risk of IPD (List 4.13.1, Category B) who received a dose of
23vPPV at 45 years of age should receive a 2nd dose of 23vPPV approximately
10 years later, at 1518 years of age. That dose should be counted as their 1st
Children aged >5 years to <18 years
adult 23vPPV dose. Based on current evidence, 13vPCV is not specifically

recommended for children in this age and risk group, regardless of previous
vaccination history.
For children in this age group with a newly identified medical condition(s)
associated with an increased risk of IPD (List 4.13.1, Category B), a single dose
of 23vPPV is recommended at the time of diagnosis. In the rare situation where
a previous dose of 23vPPV has been given (e.g. in Indigenous children in some
jurisdictions), this dose should be given at least 5 years after the previous 23vPPV
dose. The next 23vPPV dose should be given approximately 510 years after the
1st 23vPPV dose and counted as their 1st adult 23vPPV dose (see Adults with a
condition(s) associated with an increased risk of IPD below).

The recommendations for use of 23vPPV in adults who do not have a
condition(s) associated with an increased risk of IPD are summarised in Table
4.13.3. Recommendations for the use of 13vPCV and/or 23vPPV in adults with a
condition(s) associated with an increased risk of IPD (List 4.13.1, Category A or
B) are described in the text below.
The number of doses recommended depends on age, Indigenous status and the
presence of a condition(s) associated with an increased risk of IPD. Up to 3 doses
(i.e. 2 revaccinations) of 23vPPV in adulthood are recommended, depending on
these factors. This is based on limited data on adverse events and effectiveness,
as well as uncertainty regarding the clinical significance of blunting of antibody
response (immune hyporesponsiveness) following revaccination with 23vPPV,
especially with multiple revaccinations.
For adults, prior childhood doses of 23vPPV that may have been given at either
1824 months and/or 45 years of age should not be counted; that is, they are not
relevant to the recommendations given in Table 4.13.3. In the Northern Territory,
a dose of 23vPPV is provided to all Indigenous adolescents at approximately
15 years of age, based on the very high prevalence of conditions associated with
an increased risk of IPD and incidence of IPD in this population; this dose should
be considered as a dose received in adulthood for the purpose of limiting the
total lifetime number of 23vPPV doses to 3.
Although 13vPCV is registered for use in adults aged 50 years, there is currently
insufficient evidence to recommend its use in preference to 23vPPV at the
individual or population level for persons aged 18 years who do not have a
condition(s) associated with an increased risk of IPD (see 4.13.4 Vaccines above).
Updated recommendations on the use of 13vPCV in adults without an increased
risk of IPD will be made when more data are available (see Immunise Australia
website www.immunise.health.gov.au).
A single dose of 23vPPV is recommended for adults at 65 years of age. For those
aged >65 years who did not receive a dose at 65 years of age, a single catch-up
dose of 23vPPV should be offered as soon as possible. Routine revaccination with
23vPPV for non-Indigenous adults without a condition(s) associated with an
increased risk of IPD is not recommended (see Table 4.13.3).
Aboriginal and Torres Strait Islander (Indigenous) adults
A 1st dose of 23vPPV is recommended for all Indigenous adults reaching the age
of 50 years (Table 4.13.3). This is based on the increased risk of IPD in Indigenous
adults compared with non-Indigenous adults, and the high prevalence of
conditions associated with an increased risk of IPD (including tobacco smoking)
in Indigenous adults after 50 years of age, compared with younger ages. A 2nd
dose of 23vPPV is recommended 5 years after the 1st dose. For those aged
50 years who have never received a dose of 23vPPV, a 1st dose should be
offered as soon as possible, with a 2nd dose recommended 5 years after the
1st dose.
Indigenous adults aged <50 years with a condition(s) associated with an
increased risk of IPD (List 4.13.1), should be vaccinated according to the
recommendation for Adults with a condition(s) associated with an increased risk
of IPD below.
Non-Indigenous adults
Table 4.13.3: R
ecommendations for pneumococcal vaccination using 23vPPV
for adults who do not have a condition(s) associated with an
increased risk of invasive pneumococcal disease (IPD)*
Non-Indigenous adults
Current age (years) 1st dose of 23vPPV 2nd dose of
23vPPV
(1st revaccination)
18 to <65 years
Not recommended Not recommended
65 years
Give now
Not recommended
Indigenous adults
Current age (years) 1st dose of 23vPPV 2nd dose of
23vPPV
(1st revaccination)
18 to <50 years
Not recommended Not recommended
5 years after 1st
50 years
Give now
dose
3rd dose of 23vPPV

(2nd revaccination)
Not recommended
Not recommended
3rd dose of 23vPPV
(2nd revaccination)
Not recommended
Not recommended
* See List 4.13.1 for conditions associated with an increased risk of IPD. Recommendations for
those who have a condition(s) that places them at an increased risk of IPD are listed in the text
below.
In the Northern Territory, a dose of 23vPPV is provided to all Indigenous adolescents at
approximately 15 years of age, based on the very high prevalence of conditions associated
with an increased risk of IPD and incidence of IPD in this sub-population. This dose should be
considered a dose received in adulthood for the purpose of limiting the total lifetime number of
23vPPV doses to 3.
The minimum interval between any 2 doses of 23vPPV should be 5 years, and no more than 3
lifetime adult doses of 23vPPV are recommended.
Adults with a condition(s) associated with an increased risk of IPD (List 4.13.1)
Use of 13vPCV
Adults with a medical condition(s) associated with the highest increased
risk of IPD in List 4.13.1, Category A (immunocompromising conditions,
functional or anatomical asplenia, CSF leak, cochlear implant), are
recommended to receive a single dose of 13vPCV,75 with the exception of
HSCT recipients who should receive 3 doses of 13vPCV (see Table 3.3.3
Recommendations for revaccination following HSCT in children and adults,
irrespective of previous immunisation history). For those with a newly diagnosed
(or newly recognised for the purposes of requiring vaccination) condition,
the dose of 13vPCV should be given at the time of diagnosis and followed by
23vPPV doses. The 1st 23vPPV dose should be given a minimum of 2 months
after 13vPCV (see Use of 23vPPV below). For adults with a pre-existing
condition listed in Category A, and who have received 1 or more prior doses
of 23vPPV, the dose of 13vPCV should be given at least 12 months after the
most recent dose of 23vPPV. (See also Persons with functional or anatomical
asplenia in 3.3.3 Vaccination of immunocompromised persons.)
Use of 23vPPV
All adults with a condition(s) associated with an increased risk of IPD (List 4.13.1,
Categories A and B) are recommended to receive additional doses of 23vPPV
(compared with those who do not have an increased risk).
In adults with a pre-existing condition (List 4.13.1, Categories A and B) the 1st
adult dose of 23vPPV is recommended at approximately 18 years of age (see also
Children aged >5 years to <18 years above), or a minimum of 5 years after the
most recent dose of 23vPPV, and is to be followed by up to 2 additional doses.
For those newly diagnosed, or who have never received pneumococcal vaccination,
a 1st dose of 23vPPV is recommended at identification of the risk condition if
they are in Category B. If the adult has a condition(s) associated with the highest
increased risk of IPD (listed in Category A), they should receive a single dose
of 13vPCV at time of diagnosis (see above), followed by a 1st dose of 23vPPV a
minimum of 2 months later.
A 2nd dose of 23vPPV is recommended for all at-risk adults in Categories A and
B at approximately 510 years (minimum of 5 years) after the 1st dose of 23vPPV.
A 3rd dose of 23vPPV is recommended at the age of 50 years for Indigenous
adults and 65 years for non-Indigenous adults, or a minimum of 5 years after the
2nd dose, whichever is later.
For older adults with a newly diagnosed condition who have already received
an age-based 1st dose of 23vPPV at age 65 years (non-Indigenous) or 50 years
(Indigenous), a single revaccination dose of 23vPPV is recommended a minimum
of 5 years after the previous dose of 23vPPV. For persons with a medical
condition(s) associated with the highest increased risk of IPD (Category A), a
3rd dose of 23vPPV is recommended, a minimum of 5 years after the 2nd dose or
at age 65 years, whichever is later.
If a younger adult (e.g. an Indigenous adult living in the Northern Territory)
has received a dose of 23vPPV before identification of a risk condition in
Category B, a 2nd dose of 23vPPV is recommended at diagnosis of the
condition, or a minimum of 5 years after the 1st dose, whichever is later. A 3rd
dose of 23vPPV is recommended at the age of 50 years for Indigenous adults
and 65 years for non-Indigenous adults, or a minimum of 5 years after the 2nd
dose, whichever is later.
In general, no more than three 23vPPV doses are recommended during a
persons adult life.
Adults who have a condition listed in Category B in List 4.13.1 are not
recommended to receive 13vPCV. 13vPCV is registered for use in children up
to the age of 5 years only and in adults aged 50 years, and data in adults and
in immunocompromised persons is limited. However, based on extrapolation
from data on the 7vPCV,76 providing a dose of 13vPCV to adults at the highest
increased risk of IPD is likely to be beneficial.

23vPPV is not routinely recommended for pregnant or breastfeeding women.
Although 23vPPV has been administered in pregnancy in the context of
clinical trials77 with no evidence of adverse effects, data are limited; deferral of
vaccination with 23vPPV until after delivery is recommended unless there is
an increased risk of IPD. Women of child-bearing age who have a condition(s)
associated with an increased risk of IPD should be vaccinated before a planned
pregnancy, or as soon as practicable after delivery (see 4.13.7 Recommendations
above). 23vPPV may be given to breastfeeding women.
Data on use the use of 10vPCV and 13vPCV during pregnancy or lactation are
not available. For adults with a condition(s) associated with an increased risk of
IPD for whom a dose of 13vPCV is recommended, the dose should be deferred
until after delivery and cessation of breastfeeding.
The only absolute contraindications to pneumococcal vaccines are:
anaphylaxis following a previous dose of any pneumococcal vaccine
4.13.10 Precautions
13-valent pneumococcal conjugate vaccine and inactivated influenza vaccines
One study in the United States has suggested that there is a slightly higher
risk of febrile seizure associated with concurrent administration of 13vPCV
and inactivated trivalent influenza vaccine than after receipt of either of the
vaccines alone on separate days.67 The increased likelihood of febrile seizures
occurred within 1 day of vaccination in children aged 659 months who
received 13vPCV concurrently with a 1st dose of inactivated trivalent influenza
vaccine. The risk was estimated to be about 18 excess cases per 100 000 doses
for those aged 659 months, with a peak of 45 per 100 000 doses for those
aged 16 months. Given this relatively low increase in risk, providing 13vPCV
and inactivated trivalent influenza vaccine concurrently to children aged
1223 months is acceptable; however, immunisation service providers should
advise parents regarding this, and provide the option of administering these
two vaccines on separate days (with an interval of not less than 3 days). (See
also 4.7 Influenza.) In the event that fever occurs following either vaccine, an
interval may minimise the risk of increased adverse reactions.
10-valent pneumococcal conjugate vaccine

The safety profile of 10vPCV is similar to that of 7vPCV,68 with no clinically
relevant difference when co-administered with routine childhood vaccines.69
In clinical trials, erythema, pain, or swelling of any degree at the injection site
each occurred in approximately 30 to 50% of 10vPCV recipients. Erythema
of >30 mm occurred in up to about 5% of 10vPCV recipients in the primary
course. The frequency of local adverse events was higher after the booster
dose. Irritability and drowsiness were reported in about 50% of 10vPCV
recipients when co-administered with a DTPa-combination vaccine, but severe
reactions occurred in fewer than 5%. When co-administered with DTPa-based
combination vaccines, fever with temperature 38C was reported in about 33%
of 10vPCV recipients after primary or booster doses. Approximately 2 to 6% of
10vPCV recipients reported rectal temperature >39C after primary vaccination
and 1.5 to 3% after booster vaccination.68

Pooled safety analysis from 13 clinical trials showed that the safety profile of
13vPCV in young children is similar to that of 7vPCV.70,78 Pain/tenderness and
erythema at the injection site occurred in about 50% of all 13vPCV recipients, and
induration or swelling in about 33%. Pain interfering with movement occurred
in about 8%. Moderate erythema and induration occurred more commonly after
the toddler dose than after an infant dose, in about 13% of recipients. About
37% of 13vPCV childhood recipients reported fever, with about 5% reporting
fever >39C.78 Fever occurred more frequently after the toddler dose than after
the primary doses.79 Other common systemic reactions included irritability,
drowsiness/increased sleep and decreased appetite, reported in 70%, 60% and
39% of 13vPCV recipients, respectively.78 Frequencies of each of these adverse
events were comparable to those in 7vPCV recipients.78
Post-marketing surveillance in the United States has suggested the possibility
of a higher risk of febrile seizure within a day of vaccination among those who
received concurrent administration of 13vPCV and inactivated trivalent influenza
vaccine in 20102011, compared with those who received either vaccine alone,
especially in children aged 1223 months (see 4.13.10 Precautions above).67
There is only limited information available on the safety of 13vPCV use in
adults, from a study in which adults aged 65 years received 13vPCV with or
without concurrent vaccination with the trivalent seasonal influenza vaccine.80
Pain, redness and/or swelling at the 13vPCV injection site were very common,
occurring in 47% in both groups. The common systemic reactions that were
reported significantly more often among 13vPCV than placebo recipients, both
concurrently receiving the trivalent influenza vaccine, were chills, rash and new
muscle pain. Overall, there were no significant differences in adverse event
frequencies between those with or without prior 23vPPV doses. Recipients of

concurrent administration of inactivated trivalent seasonal influenza vaccine
with 13vPCV reported a higher frequency of systemic but not local reactions.80
23-valent pneumococcal polysaccharide vaccine

The proportion of vaccine recipients reporting local and systemic reactions after a
primary or a repeat dose of pneumococcal polysaccharide vaccines varies among
different study populations, and possibly with age.55,57,81 About 50% or more of
23vPPV recipients will experience some soreness after the 1st dose, and swelling
and redness are also very common, occurring in approximately 20% of recipients.
Moderate or severe local adverse events that limit arm movement are also quite
common, occurring in up to 5% of 1st dose recipients. Systemic reactions like
myalgia, fatigue and chills are also very common. Fever 37.5C occurs in up to
10% of 23vPPV recipients, but high fever is uncommon.55,57,81
Larger and more recent studies indicate that both local and systemic adverse
events occur more commonly after a repeat dose of 23vPPV than after the
1st dose in adults, particularly more severe local adverse events, which may
occur in up to approximately 20% of revaccinated subjects.55,57,81 These findings
effectively supersede the inconsistent findings from some smaller studies, which
were limited by subject numbers and methodology.82-86 Nevertheless, the local
adverse events were mostly non-serious and self-limiting. In these studies, the
repeat doses were given at least 5 years after the previous dose. Another study,
which used hospitalisations coded as cellulitis or abscess of the upper limb
within 3 days of pneumococcal vaccination as a proxy measure for very severe
local adverse events, showed that these adverse events were significantly more
likely when a repeat dose was given within 5 years of the 1st dose.87 As severe
local reactions are also associated with higher antibody levels,57,62,81,88 this is the
likely driver of the relationship with shorter intervals between the repeat and
the primary dose and suggests that such local reactions are associated with more
robust immunity.

The product information for Prevenar 13 recommends 4 doses of 13vPCV for
vaccination commencing at 6 weeks of age, with further doses at 4, 6 and
1215 months of age; 3 doses for vaccination commencing between 7 and
11 months of age; and 2 doses for vaccination commencing between 12 and
23 months of age. The ATAGI recommends instead that 1 dose less than that
stated in the product information be given to healthy children who are not at
increased risk of IPD. The ATAGI recommends that the 1st dose be given at
2 months of age, and that this dose can be given as early as 6 weeks of age.
The next scheduled doses should be given at 4 months and 6 months of age.
13vPCV is registered for use in children up to 17 years of age and adults aged
50 years. The ATAGI recommends a dose of 13vPCV for adults of any age
who have a condition(s) associated with the highest risk of IPD (see List 4.13.1,
The product information for Pneumovax 23 states that Pneumovax 23 and

Zostavax should not be given concurrently. The ATAGI instead recommends that
while concurrent administration of Zostavax with pneumococcal polysaccharide
vaccine is not routinely recommended, and if possible the two vaccines should
be given at least 4 weeks apart, inadvertent administration of Zostavax and
pneumococcal polysaccharide vaccine at the same time or at an interval of less
than 4 weeks does not require revaccination.
References
Category A). This is based on the likely benefit outweighing uncertainties and
risks, and on immunogenicity and safety data in children.
4.14 POLIOMYELITIS
4.14.1 Virology
Polioviruses are classified as enteroviruses in the family Picornaviridae.1 They
have an RNA genome, and can inhabit the gastrointestinal tract transiently.
There are three poliovirus serotypes, referred to as either type 1, type 2 or type 3.
The virus enters through the mouth, multiplies in the pharynx and gut and is
excreted in the stools for several weeks. The virus invades local lymphoid tissue,
enters the bloodstream and may then infect and replicate in cells of the central
nervous system.2

Poliomyelitis is an acute illness following gastrointestinal infection by one of the
three types of poliovirus. Transmission is through faecaloral and, occasionally,
oraloral spread.3 The infection may be clinically inapparent. If symptoms
occur, they may include headache, gastrointestinal disturbance, malaise and
stiffness of the neck and back, with or without paralysis. Paralysis is classically
asymmetrical. Paralytic polio is a complication of poliovirus aseptic meningitis,
and may be spinal (79%), bulbar (2%) or bulbospinal (19%). The case-fatality
rate in paralytic polio is 2 to 5% in children and 15 to 30% in adults. The casefatality rate in bulbar polio is up to 75%. The infection rate in households
with susceptible young children can reach 100%. The ratio of inapparent or
asymptomatic infection to paralytic infection may be as high as 1000:1 in
children and 75:1 in adults, depending on the poliovirus type and social and
environmental conditions.2
The incubation period ranges from 3 to 21 days. Infected persons are most
infectious from 7 to 10 days before to 7 to 10 days after the onset of symptoms.
The oral vaccine virus may be shed in the faeces for 6 weeks or more,2 and for up
to several years in people who are immunocompromised. Oral vaccine strains
shed for many years may mutate into potentially neurovirulent strains.4-9
4.14.3 Epidemiology
The incidence of poliomyelitis has been dramatically reduced worldwide with
the World Health Organization (WHO) aiming to achieve cessation of all wild
poliovirus transmission worldwide by 2013 through an intensified Global Polio
Eradication Initiative. There have been imported poliomyelitis case reports in
parts of Southeast Asia, eastern Europe and Africa.10-12 Further information is
available from the WHO Polio Eradication website (www.polioeradication.org).
In 1994, the continents of North and South America were certified to be free of
polio,13 followed by the Western Pacific region (including Australia) in 200014
and the European region in 2002.15 In countries where the disease incidence is
low but transmission is still occurring, poliomyelitis cases are seen sporadically
or as outbreaks among non-vaccinated persons. In 2012, polio had been
virtually eradicated in India, but there were still cases in Afghanistan, Nigeria
and Pakistan.16
4.14.4 Vaccines
IPOL Sanofi Pasteur Pty Ltd (IPV; inactivated poliovirus). Each
0.5mL pre-filled syringe contains 40 D-antigen units inactivated
32 D-antigen units type 3 (Saukett); 23L phenoxyethanol; 220g
formaldehyde; polysorbate 80; traces of neomycin, streptomycin,
polymyxin B and bovine serum albumin.
Combination vaccines that contain IPV

4.14 POLIOMYELITIS
In Australia, the peak incidence of poliomyelitis was 39.1/100 000 in 1938. There
has been a dramatic fall in incidence since 1952, but epidemics occurred in 1956
and 196162. The most recent laboratory-confirmed case of wild poliomyelitis
in Australia occurred in 2007 in an overseas-born student who acquired the
disease during a visit to Pakistan.17 The last case of wild poliomyelitis prior to
this was in 1977, due to an importation from Turkey, but two vaccine-associated
cases were notified in 1986 and 1995.18,19 Because of the rapid progress in global
polio eradication and the diminished risk of wild virus-associated disease,
inactivated poliomyelitis vaccine (IPV) is now used for all doses of polio vaccine
in Australia.3,20 The advantage of using IPV is that it cannot cause vaccineassociated paralytic poliomyelitis (VAPP).21 Emergence of highly evolved
vaccine-derived polioviruses (VDPV) in persons with primary immunodeficiency
(iVDPV) with long-term excretion, and polio outbreaks due to circulating VDPV
(cVDPV), particularly in areas with low vaccine coverage, are associated with
oral poliomyelitis vaccine (OPV) administration.22,23

syringe contains 30IU diphtheria toxoid, 40IU tetanus toxoid,
25g PT, 25g FHA, 8g PRN, 40 D-antigen units inactivated
poliovirus type 1 (Mahoney), 8 D-antigen units type 2 (MEF-1)
and 32 D-antigen units type 3 (Saukett), adsorbed onto aluminium
hydroxide; traces of formaldehyde, polysorbate 80, polymyxin and
neomycin.
and streptomycin.
neomycin.
Reduced antigen formulations for adults, adolescents and children aged 10 years

IPV (IPOL) and IPV-containing combination vaccines contain polioviruses

of types 1, 2 and 3 inactivated by formaldehyde. A course of 3 doses with an
interval of 2 months between each dose produces long-lasting immunity (both
mucosal and humoral) to all three poliovirus types. IPV produces considerably
lower levels of intestinal immunity than OPV.


The dose of IPV (IPOL) is 0.5mL, to be given by SC injection. If IPV (IPOL) is
inadvertently given intramuscularly, there is no need to repeat the dose.
The dose of the IPV-containing combination vaccines is 0.5mL, to be given by
IM injection.
The primary course consists of 3 doses of vaccine. An interval of 2 months
between doses is recommended, but the minimum interval can be as short as
1 month for catch-up in children or adults.
Interchangeability of oral and inactivated poliomyelitis vaccine

OPV is no longer in use in Australia. OPV and IPV are interchangeable.
Children commenced on OPV should complete their polio vaccination schedule
using IPV (IPOL) or IPV-containing vaccines.25
4.14 POLIOMYELITIS

and streptomycin.
Primary vaccination of infants and children
IPV (IPOL) or IPV-containing vaccines are recommended for infants at 2, 4 and
6 months of age. The 1st dose of an IPV-containing vaccine can be given as
early as 6 weeks of age. If the 1st dose is given at 6 weeks of age, the next
scheduled doses should still be given at 4 months and 6 months of age. An
open, randomised, multi-centre trial comparing the hexavalent and pentavalent
IPV-containing vaccines found that infants receiving either vaccine at 2, 4 and
6 months of age had seroprotective levels of antibody to poliovirus types 1, 2
and 3.26 Extra doses of IPV (IPOL) or IPV-containing vaccines are not needed for
babies born prematurely.
Where only IPV vaccination is required, IPOL can be used for catch-up in
children. If other antigens including poliomyelitis are required, Infanrix IPV
or Infanrix hexa can be used for catch-up in children aged <10 years (see 2.1.5
Catch-up).
Booster doses for children

A booster dose of IPV (IPOL) or IPV-containing vaccine is recommended at
4 years of age. This is commonly provided as DTPa-IPV, which can be given as
early as 3.5 years (see also 4.12 Pertussis and 4.19 Tetanus).
A completed poliomyelitis vaccination schedule for children is 3 primary doses
and 1 booster dose of IPV (IPOL) or an IPV-containing vaccine.
Where a child received their 3rd primary dose of IPV or an IPV-containing
vaccine after the age of 4 years, a booster dose is not required.
Primary vaccination of adults

A course of 3 doses of IPV (IPOL) or IPV-containing vaccines is recommended for
the primary vaccination of adults. No adult should remain unvaccinated against
poliomyelitis. For more information see 2.1.5 Catch-up.
Booster doses for adults

Booster doses for adults are not necessary unless an individual is at special risk,
such as:
travellers to areas or countries where poliomyelitis is epidemic or endemic;25
see also WHO recommendations on vaccinations for travellers (www.who.
int/ith/chapters/en/index.html)27 and 3.2 Vaccination for international travel
healthcare workers, including laboratory workers, in possible contact with
poliomyelitis cases or poliomyelitis virus.
For those exposed to a continuing risk of infection, booster doses are desirable
every 10 years. dTpa-IPV combination vaccines can be used where otherwise
indicated.

The only absolute contraindications to IPV (IPOL) or IPV-containing vaccines are:
anaphylaxis following a previous dose of any IPV-containing vaccine

IPV (IPOL) or IPV-containing vaccines cause erythema (in 33% of vaccine
recipients), pain (in 13%), and induration (in 1%) at the injection site. Other
symptoms reported in young babies are fever, crying and decreased appetite (in
5 to 10%).
Repeat doses of IPV or IPV-containing vaccines have not been associated with
increased adverse events and, where extra doses are required, are safe.
4.14.11 Public health management of poliomyelitis

Poliomyelitis is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of poliomyelitis,
including management of cases of poliomyelitis and their contacts, should

<10 years of age.
4.14 POLIOMYELITIS
IPV (IPOL) or IPV-containing vaccines are not routinely recommended for

pregnant or breastfeeding women, but can be given where vaccination is
considered necessary (see 4.14.7 Recommendations above).
The product information for Boostrix-IPV states that dTpa-containing vaccine
should not be given within 5 years of a tetanus toxoid-containing vaccine. The
product information for Adacel Polio states that dTpa-containing vaccine should
not be given within 3 years of a tetanus toxoid-containing vaccine. The ATAGI
recommends instead that, if protection against pertussis is required, dTpacontaining vaccines can be administered at any time following receipt of a dTcontaining vaccine.
The product information for Boostrix-IPV and Infanrix IPV states that these
vaccines are contraindicated in children with encephalopathy of unknown
aetiology or with neurologic complications occurring within 7 days following a
vaccine dose. The ATAGI recommends instead that the only contraindication is a
history of anaphylaxis to a previous dose or to any of the vaccine components.
References
4.15 Q FEVER
4.15.1 Bacteriology

Q fever can be acute or chronic, and there is increasing recognition of long-term
sequelae. Infection is asymptomatic in at least half of cases.5,6
Acute Q fever usually has an incubation period of 2 to 3 weeks, depending on
the inoculum size and other variables7 (range from 4 days up to 6 weeks). Clinical
symptoms vary by country, but, in Australia, the most common presentation is
rapid onset of high fever, rigors, profuse sweats, extreme fatigue, muscle and
joint pain, severe headache and photophobia.5,6 As the attack progresses, there
is usually evidence of hepatitis, occasionally with frank jaundice; a proportion
of patients may have pneumonia, which is usually mild but can require
mechanical ventilation. If untreated, the acute illness lasts 1 to 3 weeks and may
be accompanied by substantial weight loss in more severe cases.5,6 Infection often
results in time off work, lasting a few days to several weeks.8
C.burnetii may cause chronic manifestations, the most commonly
reported being subacute endocarditis. Less common presentations include
granulomatous lesions in bone, joints, liver, lung, testis and soft tissues.
Infection in early pregnancy, or even before conception, may recrudesce at term
and cause fetal damage.9-11
Studies have also identified a late sequela to infection, post Q fever fatigue
syndrome (QFS), which occurs in about 10 to 15% of patients who have
previously had acute Q fever.12-15 Research suggests that non-infective antigenic
complexes of C.burnetii persist for many years after acute Q fever, and the
maintenance of immune responses to these antigens might be the biological basis
by which QFS occurs.13,16-18
4.15.3 Epidemiology
C.burnetii infects both wild and domestic animals and their ticks, with cattle,
sheep and goats being the main sources of human infection.19-21 Companion
animals such as cats and dogs may also be infected, as well as native Australian
animals such as kangaroos, and introduced animals such as feral cats and
camels.19,21-23 The animals shed C.burnetii into the environment through their
placental tissue or birth fluids, which contain exceptionally high numbers of
Coxiella organisms, and also via their milk, urine and faeces. C.burnetii is highly
infectious24 and can survive in the environment. The organism is transmitted to
4.15 Q FEVER
Q fever is caused by Coxiella burnetii, an obligate intracellular bacterium.1 The

organism is inactivated at pasteurisation temperatures. It survives well in air,
soil, water and dust, and may also be disseminated on fomites such as wool,
hides, clothing, straw and packing materials.2,3 C.burnetii has been weaponised
and is considered a Category B biothreat agent.4
humans via the inhalation of infected aerosols or dust. Those most at risk include
workers from the meat and livestock industries and shearers, with non-immune
new employees or visitors being at highest risk of infection. Nevertheless,
Q fever is not confined to occupationally exposed groups; there are numerous
reports of sporadic cases or outbreaks in the general population in proximity to
infected animals in stockyards, feedlots, processing plants or farms. Although
most notifications occur among men from rural areas or with occupational
exposure, a recent serosurvey from Queensland indicated a high rate of exposure
among urban residents, including women and children.25
Use of Q fever vaccine in Australia can be considered in 4 periods: from 1991
to 1993, when vaccine was used in a limited number of abattoirs; from 1994
to 2000, when vaccination steadily increased to cover large abattoirs in most
states;26 from 2001 to 2006, during the period of the Australian Government
sponsored National Q fever Management Program (NQFMP);27 and the period
since 2007 after the NQFMP finished, where the vaccination remains available
on the private market. The NQFMP funded screening and vaccination of abattoir
workers and shearers and then extended vaccination to farmers, their families
and employees in the livestock-rearing industry. Following introduction of
the program, the number of Q fever cases reported to the National Notifiable
Diseases Surveillance System declined by over 50% (see Figure 4.15.1),27 with
the greatest reductions among young men aged 1539 years, consistent with
high documented vaccine uptake among abattoir workers.26-28 As a result, other
occupational groups as well as non-occupational animal exposures appear to be
accounting for an increasing proportion of notifications.8,29
Figure 4.15.1: Q fever notifications for Australia, New South Wales and
Queensland, 1991 to 200930
National Q Fever Management
Program Phase 1
12
10
Phase 2 implementation
July 2002 to June 2005
Qld
NSW
Aust
6
4
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994
1993
1992
1991
14
Year
4.15.4 Vaccine
Q-Vax Skin Test CSL Limited (Q fever skin test). Each 0.5mL liquid
vial when diluted to 15mL with sodium chloride contains 16.7ng
of purified killed suspension of C.burnetii in each diluted 0.1mL
dose; thiomersal 0.01%w/v before dilution. Traces of formalin. May
contain egg proteins.
The Q fever vaccine and skin test consist of a purified killed suspension of
C.burnetii. It is prepared from the Phase I Henzerling strain of C.burnetii, grown
in the yolk sacs of embryonated eggs. The organisms are extracted, inactivated
with formalin, and freed from excess egg proteins by fractionation and
ultracentrifugation. Thiomersal 0.01%w/v is added as a preservative.
Phase I whole-cell vaccines have been shown to be highly antigenic and
protective against challenge, both in laboratory animals and in volunteer trials.31
Serological response to the vaccine is chiefly IgM antibody to C.burnetii Phase I
antigen. In subjects weakly seropositive before vaccination, the response is
mainly IgG antibody to Phase I and Phase II antigens.32 Lack of seroconversion
is not a reliable marker of lack of vaccination.31 Although the seroconversion
rate may be low, long-term cell-mediated immunity develops33 and estimates of
vaccine efficacy have ranged from 83 to 100%, based on the results of open and
placebo-controlled trials, and post-marketing studies.34-38 It is important that
vaccination status is reported for all notified cases and apparent vaccine failures
are investigated.
It should be noted that vaccination during the incubation period of a natural
attack of Q fever does not prevent the development of the disease.31
The Q fever vaccine and skin test are available for purchase in Australia through
the private market. The Australian Government may fund the vaccine and skin
test in emergency situations where there is a Q fever outbreak.

Transport the vaccine according to National vaccine storage guidelines: Strive for 5.39
Store at +2C to +8C. Do not freeze or store in direct contact with ice packs. If
vaccine has been exposed to temperatures less than 0C, do not use it. Protect
from light.
Diluted Q-Vax Skin Test should be freshly prepared, stored at +2C to +8C and
used within 6 hours.
4.15 Q FEVER
Q-Vax CSL Limited (Q fever vaccine). Each 0.5mL pre-filled

syringe contains 25g purified killed suspension of Coxiella burnetii;
thiomersal 0.01%w/v. Traces of formalin. May contain egg proteins.

The dose of Q fever vaccine is 0.5mL, to be given by SC injection, after
ascertaining that serological and skin testing have been performed and that both
tests are negative (see Pre-vaccination testing below).
Q fever vaccination and skin testing training is undertaken via an educational
video available online. Please contact the manufacturer for access details.
Q fever vaccine is not recommended in children aged <15 years. There are no
data on the safety or efficacy of Q fever vaccine in this age group.
Adolescents aged 15 years and adults

Q fever vaccine is recommended for those at risk of infection with C.burnetii.
This includes abattoir workers, farmers, stockyard workers, shearers, animal
transporters, and others exposed to cattle, camels, sheep, goats and kangaroos or
their products (including products of conception). It also includes veterinarians,
veterinary nurses, veterinary students, professional dog and cat breeders,
agricultural college staff and students, wildlife and zoo workers (working with
high-risk animals) and laboratory personnel handling veterinary specimens or
working with the organism (see also 3.3.7 Vaccination of persons at occupational
risk, Table 3.3.7 Recommended vaccinations for persons at increased risk of certain
occupationally acquired vaccine-preventable diseases).
Workers at pig abattoirs do not require Q fever vaccination.
Pre-vaccination testing
Before vaccination, persons with a negative history of previous infection
with Q fever must have serum antibody estimations and skin tests to exclude
those likely to have hypersensitivity reactions to the vaccine resulting from
previous (possibly unrecognised) exposure to the organism.
If the person has a positive history of previous infection with Q fever, or
has already been vaccinated for Q fever, vaccination is contraindicated and
therefore skin testing and serology are not required. (See also below.)
It is essential to take a detailed history and to obtain documentation of
previous Q fever vaccination or laboratory results confirming Q fever
disease in all potential vaccinees. Some persons who have had verified
Q fever disease in the past may show no response to serological or skin
testing; however, they may still experience serious reactions to Q fever
vaccine. Persons who have worked in the livestock or meat industries for
some time should be questioned particularly carefully. The Australian
Q Fever Register (www.qfever.org), established by Meat and Livestock
Australia (MLA), has records of receipt of Q fever vaccination for some
individuals, which can be accessed by registered users. If there is any doubt

about serological or skin test results, testing should be repeated 2 to 3 weeks
later (see below for interpretation).
Skin testing and interpretation should only be carried out by experienced

personnel. Details of immunisation service providers trained in the
administration of Q fever skin testing can be obtained online from the
Australian Q Fever Register (www.qfever.org). Skin testing is performed
by diluting 0.5mL of the Q-Vax Skin Test in 14.5mL of sodium chloride
(injection grade). Diluted Q-Vax Skin Test should be freshly prepared, stored
at +2C to +8C and used within 6 hours. A 0.1mL dose of the diluted Q-Vax
Skin Test is injected intradermally into the volar surface of the forearm.
Commercial isopropyl alcohol skin wipes should not be used. If the skin is
not visibly clean, then methylated spirits may be used. Skin reactions are
common 3 to 4 days after skin testing; however, these reactions generally
resolve by day 7 when the skin test is read. A positive reaction is indicated
by any induration at the site of injection after 7 days. Individuals giving such
a reaction must not be vaccinated, because they may develop severe local
reactions.
The result of testing is considered indeterminate when skin test induration
is just palpable and the antibody test is either equivocal or negative, or when
there is no skin induration and an equivocal antibody test (see Table 4.15.1).

An indeterminate result, which occurs in only a small proportion of subjects,

may be the consequence of past infection with Q fever. It may also merely
indicate the presence in the subject of antibodies to antigens shared between
C.burnetii and other bacteria. Australian Q fever vaccine providers have
dealt with this finding in one of two ways:
Repeat the skin test and interpret as per the guidelines for initial testing.
Collect serum 2 to 3 weeks later to look for a rise in titre of C.burnetii
antibodies in the IFA test, using Phase I and Phase II antigens and
immunoglobulin class analysis. A significant increase (defined as a
4-fold rise in titre of paired sera) indicates previous Q fever infection and
vaccination is then contraindicated.
4.15 Q FEVER
Serological and skin test results should be taken into account, according to
Table 4.15.1, before vaccination. Antibody studies were originally done by
complement fixation (CF) tests at serum dilutions of 1 in 2.5, 5 and 10 against
the Phase II antigen of C.burnetii. Although this is generally satisfactory,
many testing laboratories now use enzyme immunoassay (EIA) or
immunofluorescent antibody (IFA) to detect IgG antibody to C.burnetii as an
indicator of past exposure. Subjects who are CF antibody positive at 1 in 2.5,
IFA positive at 1 in 10 or more, or with a definite positive absorbance value in
the EIA, should not be vaccinated.
Vaccinate the subject using SC injection of a 5g (0.1mL) dose instead of

a 25g (0.5mL) dose of the vaccine. If there are no adverse events (e.g.
severe local induration or severe systemic effects, perhaps accompanied
by fever) 48 hours after the injection, a further 0.4mL (20g) dose of
the vaccine is given within the next 2 to 3 weeks, that is, before the
development of cell-mediated immunity to the 1st dose.
Table 4.15.1: I nterpretation and action for serological and skin test results (with
modifications from A guide to Q fever and Q fever vaccination
(CSL Biotherapies, 2009)6)
Serology
Skin test
Interpretation/Action
Positive antibody test*
Any skin test result
Sensitised: do not vaccinate
Equivocal antibody test
Positive
Borderline or Negative

Indeterminate (see above)
Negative antibody test#
Positive
Borderline
Negative

Indeterminate (see above)
Non-immune: vaccinate
* Positive antibody test: CF antibody or IFA positive (according to criteria used by diagnosing
laboratory [see above]; or definite positive EIA absorbance value (according to manufacturers
instructions)
Equivocal antibody test: CF antibody or IFA equivocal (according to criteria used by diagnosing
laboratory); or equivocal EIA absorbance value (according to manufacturers instructions)
Positive skin test: induration present
Borderline skin test: induration just palpable
Negative skin test: no induration
# Negative antibody test: CF antibody or IFA negative (according to criteria used by diagnosing
laboratory); or definite negative EIA absorbance value (according to manufacturers instructions)
Booster doses
Immunity produced by the vaccine appears to be long-lasting (in excess of
5 years). Until further information becomes available, revaccination or booster
doses of the vaccine are not recommended because of the risk of accentuated
local adverse events.

Q fever vaccine is not routinely recommended for pregnant or breastfeeding
women.
Q fever vaccine contains inactivated products; inactivated bacterial vaccines are
not considered to be harmful in pregnancy. However, safety of the vaccine in
pregnancy has not been established. No information is available on the use of
Q fever vaccine during breastfeeding.

persons with a history of laboratory-confirmed Q fever, or with medical
documentation that supports a previous diagnosis of Q fever
persons shown to be immune by either serological testing or sensitivity to the
organism by skin testing
persons who have been previously vaccinated against Q fever
persons with known hypersensitivity to egg proteins or any component of
the vaccine (Q-Vax may contain traces of egg protein and formalin).40
There is no information available on the accuracy of skin testing or the efficacy
and safety of Q fever vaccine use in persons who are immunocompromised. In
general, skin testing and Q fever vaccine should be avoided in such persons.
There are no data on the safety or efficacy of Q fever vaccine in children. Q fever
vaccine is not recommended for use in those aged <15 years.
4.15.10 Precautions
Vaccination of subjects already immune to C.burnetii as a result of either
previous infection or vaccination may result in severe local or systemic adverse
events. It is important that persons with a negative history of previous infection
with Q fever must have serum antibody estimations and skin tests performed
prior to vaccination (see Pre-vaccination testing above).

Non-immune subjects very commonly show local tenderness (48%) and
erythema (33%) at the vaccination site. Local induration or oedema is uncommon,
occurring in <1% of recipients. General symptoms occur commonly in about 10%
of vaccine recipients and may include mild influenza-like symptoms, such as
headache (9%), fever (up to 0.2%), chills and minor sweating.6,40
Erythematous skin reactions are common 3 to 4 days after skin testing; however,
these reactions generally resolve by day 7 when the skin test is read.
There were also two patterns of more significant adverse events among the
estimated more than 130 000 persons vaccinated between 1989 and 2004.5,26
The first and familiar pattern is the intensified local reaction at the injection
site, which may occur shortly after vaccination in individuals sensitised
immunologically by previous infection or vaccination. Rarely, an abscess
develops and requires excision and drainage. This acute reaction may be
accompanied by short-term systemic symptoms resembling the post Q fever
fatigue syndrome. However, not all those with positive pre-vaccination skin
and/or serological tests develop severe reactions. The use of the pre-vaccination
4.15 Q FEVER
Q fever vaccine is contraindicated in the following groups:
skin test developed by the US National Institute of Health and the National
Institute of Allergy and Infectious Diseases,41 which was later combined with
antibody testing in Australia, has largely eliminated reactions due to previous
immune sensitisation. Despite this, the adverse experience from earlier American
trials,31 in which subjects were not pre-tested, were vaccinated repeatedly or were
inoculated with vaccines of a different composition and larger bacterial mass,
are still quoted in the general Q fever literature as representative of the broader
experience with whole-cell Q fever vaccines.
The second, much less frequent, pattern has been reported in people who are
skin and antibody test-negative at the time of vaccination and who do not have
any immediate reaction. Some 1 to 8 months after vaccination, some vaccine
recipients, predominantly women, have developed an indurated lesion at the
inoculation site. At the time when the indurated lesion develops, the original
skin test site often becomes positive, presumably indicating a late developing
cellular immune response. These lesions are not fluctuant and do not progress
to an abscess. Most gradually decline in size and resolve over some months
without treatment. A few lesions have been biopsied or excised and have shown
accumulations of macrophages and lymphocytes.42,43
4.15.12 Public health management of Q fever

Q fever is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of Q fever, including
management of cases of Q fever, should be obtained from state/territory public

The product information for Q-Vax does not include the use of a reduced dose of
vaccine in persons who have indeterminate results on either serological or skin
testing. The ATAGI recommends instead that experienced Q fever vaccinators
may elect to give reduced vaccine doses in subjects who have indeterminate
results on either serological or skin testing.
References
4.16.1 Virology
Lyssaviruses are single-stranded RNA viruses in the family Rhabdoviridae,
genus Lyssavirus. There are 12 known species within the genus Lyssavirus,
including the classical rabies virus and other closely related lyssaviruses such as
the Australian bat lyssavirus (ABLV) and European bat lyssaviruses.1

Rabies is a zoonotic disease caused by human exposure to saliva or nerve
tissue of an animal infected with rabies virus or other lyssaviruses. As the
clinical disease caused by classical rabies virus and other lyssaviruses is
indistinguishable, the term rabies refers to disease caused by any of the known
lyssavirus species.2-5 Human exposure can occur via a scratch or bite that has
broken the skin, or via direct contact with the mucosal surface of a person,
such as nose, eye or mouth. Most human cases of rabies occur after animal
bites cases after animal scratches, the licking by animals of open wounds or
contact of animal saliva with intact mucous membranes are very rare. Aerosol
transmission has never been well documented in the natural environment.6 There
has been transmission of rabies virus reported following tissue transplantation
from donors who died with undiagnosed rabies.7 Transmission of rabies virus to
humans through unpasteurised milk may be possible; however, rare reports of
transmission via this route have not been confirmed.8
Once a person is infected, the incubation period of rabies is usually 3 to 8 weeks,
but can range from as short as a week to, on rare occasions, several years. The
risk of rabies is higher, and the incubation period shorter, after severe and
multiple wounds proximate to the central nervous system (such as on the head
and neck) and in richly innervated sites (such as the fingers).
Rabies is almost invariably fatal. Typically, in the prodromal phase of rabies,
which lasts up to 10 days, the patient may experience non-specific symptoms
such as anorexia, cough, fever, headache, myalgia, nausea, sore throat, tiredness
and vomiting.9 Paraesthesiae and/or fasciculations at or near the site of the
wound may be present at this stage. Anxiety, agitation and apprehension may
also occur. Most rabies patients present with the furious or encephalitic form.10
In the encephalitic phase, objective signs of nervous system involvement include
aerophobia, hydrophobia, bizarre behaviour, disorientation and hyperactivity.
Signs of autonomic instability such as hypersalivation, hyperthermia and
hyperventilation may occur.10 The neurological status of the patient deteriorates
over a period of up to 12 days, and the patient either dies abruptly from cardiac
or respiratory arrest, or lapses into a coma.
4.16 RABIES AND OTHER

LYSSAVIRUSES (INCLUDING
AUSTRALIAN BAT LYSSAVIRUS)
4.16 RABIES AND OTHER LYSSAVIRUSES (INCLUDING

4.16.3 Epidemiology
The epidemiology of rabies varies depending on the lyssavirus species and the
animal host. Lyssaviruses have been found in all continents, except Antarctica.11
Rabies that is due to the classical rabies virus and occurs in land dwelling
(terrestrial) mammals is present throughout much of Africa, Asia, the Americas
and Europe, where the virus is maintained in certain species of mammals,
particularly dogs. In countries where rabies vaccination of domestic animals is
widespread (North America and Europe), wild animals such as raccoons and
foxes are important reservoirs. The continual maintenance of rabies in animal
populations in these countries is referred to as enzootic rabies. Australia, New
Zealand, Japan, Papua New Guinea and Pacific island nations are currently free
of rabies in terrestrial mammals. However, a countrys status can change at any
time. For example, in 2008 on the island of Bali, Indonesia, rabies was reported
in dogs, with cases later reported in humans.12 Prior to this, Bali had been
considered free of rabies, although rabies was known to occur in other areas of
Indonesia.13
In some parts of the world, bats are important reservoirs of classical rabies
as well as other lyssaviruses, with bat lyssaviruses found in areas that are
considered free from terrestrial rabies. ABLV was first reported in bats in 1996;
since then, two cases of fatal encephalitis caused by ABLV have been reported
in Australians, one in 1996 and the other in 1998.2,14 Both patients had been
bitten by bats. Evidence of ABLV infection has since been identified in all four
species of Australian fruit bats (flying foxes) and in several species of Australian
insectivorous bats.4,15-17 It should therefore be assumed that all Australian bats
have the potential to be infected with ABLV. Different regions in Australia have
reported higher risk of potential ABLV exposures.18,19 ABLV has not been isolated
from bats outside Australia. However, closely related lyssaviruses are found in
bats in other countries. For example, European bat lyssavirus 1 and European
bat lyssavirus 2 have been isolated in bats in some parts of Europe. Four human
deaths from European bat lyssavirus variants have been reported in Europe, all
with no record of prophylactic rabies immunisation.3,5 As such, bats anywhere in
the world should be considered a potential source of lyssaviruses and a potential
risk for acquiring rabies, depending on the exposure.
Information on the global occurrence of rabies can be obtained from reputable
international authorities.11,20,21 In addition, advice on potential lyssavirus
exposures and their management should be obtained by contacting the relevant
Australian state/territory health authorities (see 4.16.12 Public health management
of lyssavirus infections below).
Mrieux Inactivated Rabies Vaccine Sanofi Pasteur Pty Ltd (human

diploid cell vaccine [HDCV]). Lyophilised powder in a monodose
vial with 1.0mL distilled water as diluent. Each 1.0mL reconstituted
dose contains 2.5IU inactivated rabies virus; 100150g neomycin;
70mg human serum albumin; trace of phenol red (indicator). May
contain trace amounts of bovine gelatin and -propiolactone.
Rabipur Inactivated Rabies Virus Vaccine CSL Limited/Novartis
Vaccines and Diagnostics Pty Ltd (purified chick embryo cell
vaccine [PCECV]). Lyophilised powder in a monodose vial with
1.0mL distilled water as diluent. Each 1.0mL reconstituted dose
contains 2.5IU inactivated rabies virus; trace amounts of neomycin,
chlortetracycline, trometamol, -propiolactone, monopotassium
glutamate and amphotericin B. May contain trace amounts of bovine
gelatin and egg protein.
There are two inactivated rabies cell culture-derived vaccines available

in Australia.
The Mrieux vaccine is a lyophilised, stabilised suspension of inactivated Wistar
rabies virus that has been cultured on human diploid cells and then inactivated
by -propiolactone. This human diploid cell vaccine (HDCV) is coloured offwhite, but after reconstitution with the diluent it turns a pinkish colour due to
the presence of phenol red. The vaccine does not contain a preservative.
Rabipur is a lyophilised, stabilised suspension of inactivated Flury LEP rabies
virus that has been cultured on purified chick embryo cells and then inactivated
by -propiolactone. This purified chick embryo cell vaccine (PCECV) does not
contain a preservative.
Rabies vaccine is effective and safe when used for pre-exposure prophylaxis
(PreP) and post-exposure prophylaxis (PEP) for rabies virus.22,23 Although data on
the effectiveness of rabies vaccine as prophylaxis against other lyssaviruses are
limited, the available animal data and clinical experience support its use.19,24-29
4.16.5 Rabies immunoglobulin

Imogam Rabies Pasteurized Sanofi Pasteur Pty Ltd (human rabies
immunoglobulin [HRIG]). Each 1.0mL contains IgG class human
rabies antibodies with a minimum titre of 150IU; 22.5mg glycine;
1mg sodium chloride. Supplied in 2mL vials.

4.16.4 Rabies vaccines
Human rabies immunoglobulin (HRIG) is prepared by cold ethanol fractionation

from the plasma of hyperimmunised human donors.

Rabies vaccine
Both rabies vaccines must be reconstituted by adding the entire contents of
the diluent container to the vial and shaking until the powder is completely
dissolved. Reconstituted vaccine should be used immediately.
Human rabies immunoglobulin

HRIG should be used immediately once the vial is opened.

Rabies vaccine
The dose of rabies vaccine for use in PreP and PEP is 1.0mL, to be given by IM
injection and is the same for infants, children and adults.
HDCV can also be given by SC injection; however, if PCECV is inadvertently
given via the SC route, the dose should be repeated.
Note: Rabies vaccination administered via the intradermal (ID) route is not routinely
used in Australia and is not recommended. The use of the ID route for rabies vaccination
is the practitioners own responsibility, as rabies vaccines are not registered for use via
this route in Australia. ID administration is particularly not recommended for postexposure prophylaxis. For detailed information on the restrictions that apply to the use
of ID vaccination, if undertaken for PreP, see Pre-exposure prophylaxis administered via
the intradermal route below.
Rabies vaccine should be given in the deltoid area, as rabies virus neutralising
antibody (VNAb) titres may be reduced after administration in other sites.
In particular, vaccine should never be given in the buttock, as failure of preexposure prophylaxis has been reported when given by this route.31 In infants
<12 months of age, administration into the anterolateral aspect of the thigh is
recommended.
Pre-exposure prophylaxis (PreP)
The recommended schedule for pre-exposure prophylaxis (PreP) for rabies or

other lyssavirus infection consists of a total of 3 doses of vaccine; the 1st dose of
vaccine is given on day 0, and subsequent doses on days 7 and 2128. Although
the 3rd dose can be given as early as 21 days, there are no data to support the use
Post-exposure prophylaxis (PEP)
In persons previously unvaccinated, the recommended schedule for postexposure prophylaxis (PEP) for immunocompetent persons consists of 4 doses
of vaccine. The 1st dose of vaccine is given as soon as practicable (day 0), and
subsequent doses are given on days 3, 7 and 14; deviations of a few days from
this schedule are probably unimportant.22
The recommended schedule for PEP for previously unvaccinated
immunocompromised persons consists of 5 doses of vaccine. The 1st dose of
vaccine is given as soon as practicable (day 0), and subsequent doses are given
on days 3, 7, 14 and 28; deviations of a few days from this schedule are probably
unimportant.
The recommended schedule for PEP for people who have been previously
vaccinated against rabies consists of 2 doses of rabies vaccine on days 0 and 3
(noting caveats in Figures 4.16.1 and 4.16.2).
For more detailed information see 4.16.8 Recommendations below.

When HRIG is indicated, the dose is 20IU per kilogram of body mass and is the
same for infants, children and adults. HRIG should be administered at the same
time as the 1st dose (day 0) of rabies vaccine. Do not administer HRIG if 8 days
or more have elapsed since the 1st dose of vaccine, as the HRIG may interfere
with the immune response to the vaccine. For more detailed information see
4.16.8 Recommendations below.
HRIG should be infiltrated in and around all wounds using as much of the calculated
dose as possible, and the remainder of HRIG administered intramuscularly at a
site away from the rabies vaccine injection site. If the wounds are severe and the
calculated volume of HRIG is inadequate for complete infiltration of all wounds
(e.g. extensive dog bites in a young child), the HRIG should be diluted in saline
to make up an adequate volume for the careful infiltration of all wounds.
Wounds to fingers and hands may be small, particularly following exposures to
bats, and infiltration of HRIG into these wounds is likely to be both technically
difficult and painful for the recipient.32 However, due to the extensive nerve
supply to these sites9,10,33 it is important that as much of the calculated dose of
HRIG as possible should be infiltrated into finger and hand wounds using either
a 25 or 26 gauge needle. To avoid the development of a compartment syndrome,
the HRIG should be infiltrated very gently, and should not cause the adjacent
finger tissue to go frankly pale or white. It may be necessary to give a ring-block
using a local anaesthetic.32

of an even more accelerated schedule for those with limited time before travel to
a rabies-enzootic area.
Interchangeability of rabies vaccines

The World Health Organization (WHO) does not recommend interchanging
rabies cell culture-derived vaccines (CCV), but states that, in situations where
it is unavoidable, a PreP or PEP course can be completed with an alternative
rabies CCV, providing the vaccine is WHO-endorsed (also termed prequalified).22 Various international vaccine advisory groups state that rabies
CCV are interchangeable. This is supported by the similarities in tissue culture
vaccine production methods as well as antibody responses and adverse
reactions following vaccination. In one study that specifically assessed the
interchangeability of HDCV and PCECV, 165 subjects were randomised to receive
rabies PreP (days 0, 7 and 2128) using either HDCV or PCECV.34 One year
following PreP, each group received 1 or 2 booster doses of PCECV. The booster
dose resulted in an anamnestic response (geometric mean titre several orders of
magnitude >0.5IU/mL) in all subjects by day 7, independent of the vaccine that
was used to deliver the primary course. It is expected that this response would be
similar with other rabies CCV.
Measures to avoid potential rabies virus and other lyssavirus (including ABLV)
exposures
Travellers to rabies-enzootic regions should be advised to avoid close contact
with either wild or domestic animals; this is particularly important for
children.35-37 They should be advised about pre-travel (i.e. pre-exposure) rabies
vaccination (or, if appropriate, booster doses), and on what to do should they
be either bitten or scratched by an animal while abroad.37-41 It is recommended
that prior to travel, travellers be educated regarding first aid treatment for rabies
exposures, irrespective of prior vaccination.
Recommendations to decrease the risk of exposure to rabies include:
Do not allow young children to feed, pat or play with animals. The height of
young children makes bites to the face and head more likely.
Avoid contact with stray dogs or cats. Remain vigilant when walking,
running or cycling.
Do not carry food, and do not feed or pat monkeys, even in popular areas
around temples or markets where travellers may be encouraged to interact
with the monkeys. In particular, avoid focusing attention on monkeys
carrying their young, as they may feel threatened and bite suddenly.
In addition, contact with bats should be avoided anywhere in the world,
including Australia. Only appropriately vaccinated and trained persons should
handle bats. If bats must be handled, safety precautions, such as wearing
protective gloves and clothing, should be observed.
PreP with rabies vaccine is recommended for:

persons liable to receive bites or scratches from bats (this includes bat
handlers, veterinarians, wildlife officers and others who come into direct
contact with bats) in any country, including Australia
travellers and expatriates who will be spending time in rabies-enzootic areas;
PreP should occur following a risk assessment that takes into consideration
the likelihood of interaction with animals and access to emergency medical
attention
persons working with terrestrial animals in rabies-enzootic areas
research laboratory personnel working with any live lyssaviruses.
Parents travelling with children to rabies-enzootic areas should consider PreP for
younger children, as many children, if bitten by dogs, are often bitten on the face
and hands because they are at an optimal height for such contact.
Serological testing to confirm seroconversion is only necessary in certain
circumstances (see Serological testing following rabies vaccination below).22
PreP simplifies the management of a subsequent exposure because fewer doses
of vaccine are needed and because rabies immunoglobulin (RIG) is not required
(see Post-exposure prophylaxis for rabies virus and other lyssavirus (including
ABLV) exposures below). This is particularly important as RIG (human or
equine) is often difficult to obtain in many developing countries and its safety
may not be guaranteed.
Pre-exposure prophylaxis administered via the intradermal route
Intradermal PreP is not recommended because, although initial antibody titres

may be higher, titres at 14 days are lower and wane more rapidly after ID
administration of rabies vaccine than after either IM or SC administration. There
may also be a slow initial immune response following exposure to rabies virus
in those given ID rabies vaccine.42-44 For these reasons, it is strongly recommended
that the IM route (IM or SC if HDCV is used) be used for pre-exposure prophylaxis. (See
also 4.16.7 Dosage and administration above.)
However, if ID rabies PreP is considered (using a dose of 0.1mL on days 0, 7 and
28) it is essential that:
it is given by vaccine providers with not only expertise in, but also regular
practice of, the ID technique
it is not administered to anyone who is immunocompromised
it is not administered to persons taking either chloroquine or other
antimalarials structurally related to chloroquine (e.g. mefloquine), at either
the time of, or within a month following, vaccination45
any remaining vaccine is discarded at the end of the session during which the
vial is opened (8 hours)

Pre-exposure prophylaxis for rabies virus and other lyssaviruses (including ABLV)
the rabies VNAb level is checked 14 to 21 days following completion of the

pre-exposure course of ID vaccine (see Serological testing following rabies
vaccination below)
it is only used for PreP for classical rabies exposures (there are no data on the
protection provided by ID rabies vaccination for the prevention of infection
with other lyssaviruses, including ABLV).
Post-exposure prophylaxis for rabies virus and other lyssavirus (including ABLV)
exposures
PEP for rabies virus and other lyssavirus exposures consists of prompt wound
management, vaccine and HRIG administration. The appropriate combination
of these components depends on the extent of the exposure, the animal source
of the exposure, the persons immune status and their previous vaccination
history. The different PEP pathways are described in more detail below and PEP
management algorithms are outlined in Figures 4.16.1 and 4.16.2.
Types of potential rabies virus and other lyssavirus (including ABLV) exposures
Three different categories of lyssavirus exposure are outlined in Table 4.16.1,

based on those already described by the WHO.22 The appropriate PEP pathway
following each of the different exposure categories varies depending on
whether the source of exposure was a terrestrial animal or a bat. Different
PEP management pathways following potential bat exposures compared with
terrestrial animal exposures are required because the risk from wounds from
bats is often difficult to determine due to the limited injury inflicted and there
is evidence that superficial bat exposures are more likely to result in human
infection.31
An algorithm detailing the appropriate PEP pathway following potential classical
rabies virus exposure from a terrestrial animal is provided in Figure 4.16.1; an
algorithm for use following potential lyssavirus exposure from a bat is provided
in Figure 4.16.2.
Table 4.16.1: L
yssavirus exposure categories, to be used in conjunction with
Figure 4.16.1 or 4.16.2 to determine appropriate post-exposure
prophylaxis
Type of exposure
Description
Category I
Touching or feeding animals, licks on intact skin, as well

as exposure to blood, urine or faeces or to an animal that
has been dead for more than 4 hours
Category II
Nibbling of uncovered skin, minor scratches or abrasions

without bleeding
Category III
Single or multiple transdermal bites or scratches,

contamination of mucous membrane with saliva from
licks, licks on broken skin
Source: Modified from WHO 201022
The relevant state/territory veterinary or health authority should be contacted

regarding any potential exposure to Australian bats (for ABLV) (see 4.16.12 Public
health management of lyssavirus infections below). This includes situations where
the category of the exposure is unsure, for example, for a person or child who
has woken up with a bat present in a confined space but with no recollection of
contact. If possible, and without placing others at risk of exposure, the bat should
be kept and arrangements promptly made for testing the bat for ABLV. Following
wound management (see below), the administration of HRIG and rabies vaccine
can be withheld if the bats ABLV status will be available within 48 hours of
the exposure. If the result will not be available within 48 hours, the appropriate
post-exposure prophylaxis should begin as soon as is practicable, following the
bat exposure algorithm as outlined in Figure 4.16.2. Where a bat is tested at a
reference laboratory and later found to be negative for ABLV, then PEP for the
person exposed to that bat can be discontinued.
Wound management in post-exposure prophylaxis
One of the most vital steps following a potential rabies virus or other lyssavirus
exposure is wound management. Immediate and thorough washing of all bite
wounds and scratches with soap and water, and the application of a virucidal
preparation such as povidone-iodine solution after the washing, are important
measures in the prevention of rabies. Consideration should also be given to the
possibility of tetanus and other wound infections, and appropriate measures
taken. Primary suture of a bite from a potentially rabid animal should be
avoided. Bites should be cleaned, debrided and infiltrated well with HRIG, when
indicated (see Figure 4.16.1 or 4.16.2).
Post-exposure prophylaxis of persons who are previously unvaccinated
Vaccine
After performing wound management, rabies vaccine should be administered
with or without HRIG (see Human rabies immunoglobulin below), depending
on the category and source of exposure, as outlined in Figure 4.16.1 or Figure
4.16.2, and described below.

The relevant state/territory health authority should be contacted about any

potential exposure sustained from a terrestrial animal in a rabies-enzootic area, or
any potential exposure sustained from a bat anywhere in the world46 (see 4.16.12
Public health management of lyssavirus infections below). Dogs and monkeys are the
usual exposures in Asia, Africa and Central and South America, but exposures to
other terrestrial mammals and bats must also be assessed for potential classical
rabies virus transmission. If a traveller presents >10 days after being bitten or
scratched by either a domestic dog, cat or ferret in a rabies-enzootic country, and
it can be reliably ascertained that the animal has remained healthy (>10 days after
the exposure), PEP is not required. Otherwise, PEP appropriate for the category
and source of exposure (see Figure 4.16.1 or 4.16.2) should be administered, even
if there has been a considerable delay in reporting the incident.
Persons who have not previously received a complete rabies vaccine course, and
are immunocompetent, should receive a total of 4 doses of rabies vaccine (see
4.16.7 Dosage and administration above). Although no clinical trial has assessed the
efficacy of rabies vaccine, the rationale supporting the use of a 4-dose schedule
in immunocompetent persons is based on 11 studies where the immunogenicity
of either cell culture-derived vaccine was consistently >0.5IU/mL by day 30
(after 4 doses) and, in a majority of participants, was >0.5IU/mL by day 14
(after 3 doses). Antibody responses observed after the 4th and 5th doses were
both several orders of magnitude larger than the WHO cut-off of 0.5IU/mL and
were similar in value. As the additional immune boosting following a 5th dose is
minimal, a 5th dose is not required in immunocompetent persons.47-57
Persons who have not previously received a complete rabies vaccine
course and who have either an immunocompromising illness, or are taking
immunosuppressant medications, should receive a 5-dose vaccine schedule
(see 4.16.7 Dosage and administration above).58-60 The rabies VNAb titre should be
measured 14 to 21 days after the 5th dose and a further dose given if the titre is
reported as inadequate (i.e. <0.5IU/mL). Serological testing should be repeated
following the 6th dose, and, if titres remain <0.5IU/mL, infectious disease
specialist advice should be sought (see Serological testing following rabies
vaccination below).
Corticosteroids and immunosuppressive therapy can interfere with the
development of active immunity and, therefore, if possible, should not be
administered during the period of post-exposure prophylaxis.61
The administration of a single dose of HRIG (see 4.16.7 Dosage and administration
above), in addition to vaccination, in previously unvaccinated persons is only
indicated in certain circumstances as outlined in Figure 4.16.1 or Figure 4.16.2,
and as described below. HRIG is given to provide localised anti-rabies antibody
protection while the person responds to the rabies vaccine. This should follow
adequate wound care (see Wound management in post-exposure prophylaxis
above).
HRIG is not recommended in persons who:
received the 1st dose (day 0) of vaccine more than 7 days prior to presenting
for HRIG (i.e. 8 days or more have elapsed since the 1st dose of vaccine was
given)
have a documented history of previous completed recommended PreP or
PEP (see 4.16.7 Dosage and administration above)
have documented evidence of adequate VNAb titres (see Serological testing
following rabies vaccination below).
Such persons should receive rabies vaccine only (see Post-exposure prophylaxis
of persons who have been previously vaccinated below).
Post-exposure prophylaxis of persons who have been previously vaccinated
Wound management must still be carried out irrespective of prior rabies

vaccination.
Persons who have evidence of a previous completed recommended PreP or PEP
regimen, or who have a previously documented adequate VNAb titre, require a
total of 2 doses of rabies vaccine (see Figure 4.16.1 or Figure 4.16.2). This includes
immunocompromised individuals; however, VNAb levels should be checked
after the 2nd dose to ensure they are adequate (see Serological testing following
rabies vaccination below).
Note: PreP or PEP vaccine administered via the ID route is not considered
appropriate previous vaccination unless documentation of an adequate VNAb
titre is available (see Serological testing following rabies vaccination below).
HRIG is not required and should not be administered, as its use may suppress
the level of anamnestic response and circulating VNAb.
In cases where a persons vaccination status is uncertain because the
documentation of a full course of rabies vaccine is not available, the full PEP
regimen should be administered.
Post-exposure prophylaxis commenced overseas
Australians travelling overseas who are exposed to a potentially rabid animal

(including bats from any country) may be given PEP using vaccines and
schedules not used in Australia. In very rare circumstances, if an older nerve
tissue-derived rabies vaccine has been administered, any doses given should be
disregarded (see Table 4.16.2). However, it is most likely that a person vaccinated
overseas will have received a cell culture-derived vaccine (see Interchangeability
of rabies vaccines in 4.16.7 Dosage and administration above).22,34 If a person
has received a cell culture-derived vaccine abroad, it is recommended that the
standard post-exposure prophylaxis regimen be continued in Australia with
either HDCV or PCECV.
WHO-approved post-exposure rabies vaccination regimens include:
Zagreb (2 doses on day 0, doses on days 7 and 21: annotated as 2-0-1-1)
Essen (doses given on days 0, 3, 7, 14 and 28 (or 30): annotated as 1-1-1-1-1)
Modified Essen (doses given on days 0, 3, 7 and 14: annotated as 1-1-1-1).
If the PEP was started overseas but HRIG or equine RIG was not given, and the
person presents in Australia within 7 days of commencing PEP, HRIG should be
given as soon as is practicable (and within 7 days of the 1st rabies vaccine dose).
If the person presents in Australia 8 days or more after commencing PEP, then
HRIG should not be administered and the appropriate number of remaining
doses of rabies vaccine administered.

Although data are limited on the effectiveness of rabies vaccine and HRIG as PEP
against infection with lyssaviruses other than classical rabies virus, the available
animal data and clinical experience support their use.19,24-29
For these and other scenarios that may arise, Table 4.16.2 outlines the most
common PEP regimens that may be commenced overseas and the recommended
schedule to complete PEP in Australia.
In the case of PEP commenced overseas, every traveller should be advised to
request a PEP certificate from the vaccination centre and to obtain or record the
following information (preferably in English):
the contact details for the clinic attended (telephone and email address)
the batch and source of RIG used (Note: equine RIG rather than human RIG
may be used in some countries)
the volume of RIG administered
the type of cell culture vaccine used
the vaccine batch number
the number of vials used
the route of vaccine administration
the date of RIG and/or vaccine administration.
These details help inform decisions about PEP on return home.
Vaccine type/route
administered overseas/
rabies immunoglobulin
(RIG)
Rabies vaccine schedule

in Australia
Nerve tissue vaccine
Recommence schedule
starting from day 0
HRIG
Category III terrestrial
animal exposures and
Category II and III bat
exposures only*
Administer HRIG if no
RIG already given
Recommence schedule
starting from day 0
Do not give HRIG if 8 days

or more since 1st dose of
vaccine (day 0)
RIG already given
Unsure/unknown/poor
documentation
Well documented, RIG

(equine or human) given,
plus vaccine given either
IM or ID
2 vaccine doses given IM
on day 0
Irrespective of whether RIG
(equine or human) was
administered at same time
as the 1st doses of vaccine
Immunocompromised
with vaccines
administered ID
Align with nearest due

dose and resume schedule
administering vaccine IM
(IM or SC if HDCV used)
Give a further 2 doses; the
1st dose on day 7 and the
2nd dose on day 14
Irrespective of number
of previous doses,
administer a 5-dose
schedule IM (IM or SC if
HDCV used) and check
serology (see Serological
testing following rabies
vaccination below)

vaccine (day 0)
No HRIG needed
RIG already given
or more since 1st doses of
vaccine (day 0)
RIG already given
vaccine (day 0)
*See Table 4.16.1 Lyssavirus exposure categories and Figures 4.16.1 and 4.16.2 for further information
of PEP pathways, including HRIG administration following either a terrestrial animal or bat
exposure.

Table 4.16.2: P
ost-exposure prophylaxis commenced overseas and
recommended completion in Australia
Figure 4.16.1: Post-exposure prophylaxis algorithm for potential exposure to

classical rabies virus from a terrestrial animal overseas
Potential exposure from a terrestrial animal in a rabies-enzootic area
Category I
Category II
Category III
Touching or feeding animals,

licks on intact skin
Exposure to blood, urine or
faeces or to an animal that
has been dead f
.
Nibbling of uncovered skin,

minor scratches or abrasions
without bleeding
Single or multiple
transdermal bites or scratches
Contamination of mucous
membrane with saliva
from licks
Licks on broken skin
No prophylaxis is
required if contact
history is reliable
Non-immune,
immunocompetent
Vaccinate
4 doses administered IM on
days 0, 3, 7 and 14. Human
rabies immunoglobulin (HRIG)
is not indicated.
Previously
immunised*
Non-immune ,
immunocompetent
Vaccinate
Both immunocompetent and
immunocompromised persons 2 doses
delivered IM on days 0 and 3. HRIG is
not indicated.
If further exposures in the future

Treat as previously immunised and
follow algorithm as above
If ongoing occupational exposure

risk see Booster algorithm
Vaccinate and administer HRIG

HRIG is administered only once, and as
soon as possible after the initiation of
PEP (HRIG is not indicated beyond the
7th day after the 1st vaccine dose on
day 0). Rabies vaccination is 4 doses
administered IM on days 0, 3, 7 and 14.
* If in doubt, treat as non-immune.

Previously immunised documentation of a completed recommended PreP or PEP rabies
vaccine regimen. This is irrespective of the time period since the last dose was administered. This
may either be a completed primary pre-exposure course or post-exposure course and includes
those where subsequent boosting has occurred, or documented rabies antibody (VNAb) titres of
0.5 IU/mL.
Non-immune person who has never received pre- or post-exposure immunisation with rabies
vaccine, has had incomplete/inadequate primary vaccination course.
Immunocompromised persons, not previously vaccinated, should receive 5 doses of vaccine
on days 0, 3, 7, 14 and 28. Serology should be checked 14 to 21 days post dose 5 and a further
dose offered if the result is <0.5 IU/mL. In immunocompromised persons, HRIG should be
administered if a Category II or III exposure.
Immunocompromised persons, previously immunised, should have serological testing 14 to 21
days after the 2nd dose to confirm acceptable VNAb levels. If the result is <0.5 IU/mL, expert
advice should be sought regarding the total number of doses required for PEP.
Potential exposure from a bat (Australia or overseas)

Category I
Touching or feeding
animals, licks on
intact skin
Exposed to blood,
urine or faeces or to
an animal that has been
dead for >4 hours
No prophylaxis is
required if contact
history is reliable.
Category II or III
Nibbling of uncovered skin, any scratches or abrasions with/without
bleeding, single or multiple transdermal bites or scratches, contamination
of mucous membrane with saliva from licks, or licks on broken skin
Previously immunised
Vaccinate
Non-immune, immunocompetent
Vaccinate and administer HRIG
Both immunocompetent
and immunocompromised
persons 2 doses delivered
IM on days 0 and 3. Human
(HRIG) is not indicated.
HRIG is administered only once, and as

soon as possible after the initiation of
PEP (HRIG is not indicated beyond the
7th day after the 1st vaccine dose on
day 0). Rabies vaccination is 4 doses
administered IM on days 0, 3, 7 and 14.
Ongoing occupational exposure risk

Perform serology
i) Every 6 months for laboratory staff at risk
ii) Every 2 years for veterinary workers, bat handlers or
any other workers who are likely to need to handle bats.
L
Give a single booster dose
If further exposure give PEP
as above
No further action until either

exposure, then give PEP as above
OR
time period elapses as above for
serology undertake VNAb serology
* If in doubt, treat as non-immune.

Previously immunised documentation of a completed recommended PreP or PEP rabies vaccine
regimen. This is irrespective of the time period since the last dose was administered. This may either
be a completed primary pre-exposure course or post-exposure course and includes those where
subsequent boosting has occurred, or documented rabies antibody (VNAb) titres of 0.5IU/mL.
Non-immune person who has never received pre- or post-exposure immunisation with rabies
vaccine or has had incomplete/inadequate primary vaccination course.
Immunocompromised persons, not previously vaccinated, should receive 5 doses of vaccine on days
0, 3, 7, 14 and 28. Serology should be checked 14 to 21 days post dose 5 and a further dose offered
if the result is <0.5 IU/mL. In immunocompromised persons, HRIG should be administered if a
Category II or III exposure.
Immunocompromised persons, previously immunised, should have serological testing 14 to 21 days
after the 2nd dose to confirm acceptable VNAb levels. If the result is <0.5 IU/mL, expert advice
should be sought regarding the total number of doses required for PEP.

Figure 4.16.2: Post-exposure prophylaxis algorithm for potential exposure to

lyssaviruses from bats in Australia or overseas
Booster doses
A recent WHO position paper applied a quality assessment of a moderate level
of scientific evidence to support that cell culture-derived rabies vaccines induce
long-term immunity of at least 10 years.22
The WHO states that booster doses are not required for persons who are
travelling to, or living in, an area of high rabies risk and who have completed
a primary course, either pre- or post-exposure, using either of the currently
available cell culture-derived vaccines.22
Booster doses of rabies vaccine are recommended for immunised persons who
have ongoing occupational exposure to lyssaviruses in Australia or overseas62
(see Figure 4.16.3).
These include:
Persons who work with live lyssaviruses in research laboratories who should
have rabies neutralising antibody titres measured every 6 months. If the titre
is reported as inadequate (<0.5IU/mL), they should have a booster dose.
Others with exposures to bats in Australia or overseas, and those who are
likely to be exposed to potentially rabid terrestrial mammals overseas,
who should have rabies antibody titres measured every 2 years. If the
titre is reported as inadequate (<0.5IU/mL), they should have a booster
dose. Alternatively, a booster dose may be offered every 2 years without
determining the antibody titre.
Points that should be considered as to whether a person should receive a booster
dose of rabies vaccine because their antibody level falls below 0.5IU/mL are:
anticipated risk of exposure (i.e. routinely handling sick animals or rabies
reservoir species in enzootic areas)
length of time until the next antibody measurement
individual health status (consider immunocompromising conditions or a
history of poor vaccine response)
timely access to vaccine and administration should a potential exposure occur.
Rabies or bat lyssavirus (including ABLV) booster algorithm

Ongoing occupational exposure risk
Perform serology
i)
ii) Every 2 years for veterinary workers, bat handlers or any other workers
who are likely to need to handle bats.
Viral neutralising antibodies
(
Give a single booster dose*
If further exposure, give PEP as
per rabies or bat lyssavirus postexposure algorithms
No further action until either

further exposure, then give
PEP as per rabies or bat
lyssavirus post-exposure
algorithms
OR
time period elapses as above
for serology undertake
VNAb serology
* Immunocompromised patients serology should be checked 14 to 21 days post booster dose and a
further dose offered if the result remains <0.5 IU/mL.
Serological testing following rabies vaccination

The WHO defines adequate immunity to rabies virus as the presence of a VNAb
titre 0.5IU/mL.63
Routine serological testing for rabies following PreP or PEP vaccination is not
usually necessary. However, persons who are immunocompromised should have
their VNAb titres determined 14 to 21 days after the 3rd dose of vaccine in a PreP
schedule or after the 5th dose of vaccine in a PEP schedule; a further dose should
be given if the titre is reported as inadequate (i.e. <0.5IU/mL). Serological testing
should then be repeated and, if titres remain <0.5IU/mL, infectious disease
specialist advice should be sought.22
If PreP was administered via the ID route, the rabies antibody level should be
checked 14 to 21 days following completion of the pre-exposure course to ensure
VNAb levels are adequate. If inadequate, expert advice should be sought.
Persons who are at risk of repeated exposure to rabies or other lyssaviruses,
including ABLV, should have their VNAb titre determined every 6 months

Figure 4.16.3: Booster algorithm for persons at ongoing risk of exposure to

either rabies or other lyssaviruses, including Australian bat
lyssavirus (ABLV)
to 2 years, depending on the risk of exposure, to assess the need for booster
vaccination (see Booster doses above).

Rabies vaccine and HRIG are recommended in pregnant or breastfeeding women
following a potential exposure to rabies virus, ABLV or another bat lyssavirus64,65
(see 4.16.8 Recommendations above and 3.3 Groups with special vaccination
requirements, Table 3.3.1 Recommendations for vaccination in pregnancy).
There are no absolute contraindications to use of either rabies vaccine or HRIG as
post-exposure prophylaxis in persons with a potential exposure to rabies or other
lyssaviruses, including ABLV. This is because rabies disease is almost always
lethal.
Persons with an anaphylactic sensitivity to eggs, or to egg proteins, should not
receive PCECV. HDCV should be used instead.
See also 4.16.11 Adverse events below.

Cell culture-derived vaccines are generally well tolerated. In a large study, the
following adverse events were reported after administration of HDCV to adults:
sore arm (in 15 to 25% of vaccine recipients), headache (in 5 to 8%), malaise,
nausea or both (in 2 to 5%), and allergic oedema (in 0.1%).66 Similar adverse event
profiles have been reported for the PCECV; these reactions occur at the same
rates in children.22,23,67-72
Although anaphylactic reactions are rare (approximately 1 per 10 000
vaccinations) following administration of HDCV, approximately 6% of persons
receiving booster doses may experience allergic reactions. The reactions typically
occur 2 to 21 days after a booster dose, and are characterised by generalised
urticaria, sometimes with arthralgia, arthritis, oedema, nausea, vomiting, fever
and malaise.66 These reactions are not life-threatening; they have been attributed
to the presence of -propiolactone-altered human albumin in the implicated
vaccines.66
HRIG has an excellent safety profile and, in general, no chance of immediate
hypersensitivity reactions as is more often the case with some equine sources of
rabies immunoglobulin.22
Management of adverse events

Once initiated, rabies post-exposure prophylaxis should not be interrupted or
discontinued because of local reactions or mild systemic reactions. Such reactions
can usually be managed with simple analgesics.
Because rabies disease is almost always lethal, the recommended vaccination
regimens, in particular the PEP regimen, should be continued even if a significant
A patients risk of developing either lyssavirus infection or rabies must be

carefully considered before deciding to discontinue vaccination.
4.16.12 Public health management of lyssavirus infections

Classical rabies virus and ABLV virus infections in humans are notifiable diseases
in all states and territories in Australia.
Other lyssavirus cases that do not meet the case definition for ABLV or rabies
virus infection are also notifiable in all states and territories in Australia.
Detailed information regarding the management of disease from rabies and other
lyssaviruses, including ABLV, can be found in the national guidelines for public
health units46 (www.health.gov.au/cdnasongs).
Both HRIG and rabies vaccine are available for PEP from the relevant state/
territory health authorities (see Appendix 1 Contact details for Australian, state and
territory government health authorities and communicable disease control).

Neither of the product information sheets for the two vaccines available in
Australia mentions that they can be used for both PreP and PEP for ABLV
exposures. The ATAGI instead recommends that, where indicated, either
of the available rabies vaccines can be used as PreP or PEP as per 4.16.8
Recommendations above.
The product information for HDCV recommends a routine 6th dose at 90 days
in a PEP regimen. The ATAGI recommends instead that a 4-dose schedule be
used for PEP in immunocompetent persons. Further doses should be offered to a
person who is immunocompromised and who has an inadequate antibody level
following the 5-dose PEP regimen.
The product information for HDCV also recommends a pre-exposure booster
after a year. The ATAGI instead recommends boosters between 6 months and
2 years for persons at continuing occupational risk (see Booster doses in 4.16.8
The product information for PCECV recommends a routine 5th dose at
28 days in a PEP regimen and the product information for HDCV recommends
a routine 5th and 6th dose at days 30 and 90, respectively, in a PEP regimen.
The ATAGI recommends instead that a 4-dose schedule with either cell culturederived vaccine be used for PEP in immunocompetent persons. A 5th dose at
day 28 should be offered to persons who are immunocompromised. Further
doses should be offered to persons who are immunocompromised and have an
inadequate antibody level following the 5th dose of PEP.
References

allergic reaction occurs following a dose of rabies vaccine. Antihistamines can be

administered in an attempt to ameliorate any subsequent reactions.
4.17 ROTAVIRUS
4.17.1 Virology
Rotaviruses are non-enveloped RNA viruses that are classified according to
the two surface proteins they contain: VP7, the G glycoprotein, and VP4, the
protease-cleaved P protein. The G and P proteins are targets for the neutralising
antibodies that contribute to protection against reinfection and disease.1,2 The
two gene segments that encode these proteins can segregate independently, and
a binary typing system, consisting of both P and G types, has been developed.
Rotavirus strains are most commonly referred to by their G serotype, with G1,
G2, G3, G4 and G9 accounting for around 90% of serotypes, both globally and in
Australia.3,4 The most common P types found in combination with these G types
are P1A[8] (found with all common G types except G2) and P1B[4], usually found
in combination with G2.5

Rotavirus is the predominant agent of severe dehydrating gastroenteritis in
infants and young children in both developed and developing countries.1,2 The
spectrum of rotavirus infection ranges from asymptomatic infection, to mild,
watery diarrhoea of limited duration, to severe dehydrating diarrhoea with
vomiting, fever, electrolyte imbalance, shock and death. Rotavirus infections are
often more severe than other common causes of diarrhoea, and are more likely to
result in dehydration and hospitalisation.1,6 The incubation period is 1 to 3 days,
after which illness can begin abruptly, with vomiting often preceding the onset
of diarrhoea.6 Up to one-third of patients have a temperature of >39C in the first
few days of illness. Symptoms generally resolve in 3 to 7 days.
4.17.3 Epidemiology
Rotaviruses are shed in high concentrations in the stools of infected children
and are transmitted by the faecaloral route, both through close person-toperson contact and via fomites.7 In some instances, rotaviruses might also be
transmitted by other modes, such as faecally contaminated food, water and
respiratory droplets.6,8
Infection in early childhood is thought to be universal. Although individuals
can be infected several times during their lives, the first infection, typically
between 3 and 36 months of age, is most likely to cause severe diarrhoea and
dehydration.9,10 The degree of protection following natural infection varies. After
a single natural infection, 40% of children are protected against any subsequent
infection with rotavirus, 75% are protected against diarrhoea from a subsequent
rotavirus infection, and 88% are protected against severe diarrhoea.10 Repeat
infections provide even greater protection. Prior to the introduction of rotavirus
vaccines in Australia, the best available estimates were that approximately
10 000 hospitalisations due to rotavirus occurred each year in children <5 years of
age,11 equating to around half the hospitalisations for acute gastroenteritis in this
In temperate Australia, rotavirus infections follow a seasonal pattern, with the

peak incidence being in mid to late winter. In the northern tropical and arid
regions, there is no consistent seasonal pattern disease peaks are unpredictable20
and widespread epidemics cause severe strain on healthcare services.21,22 Overall,
Indigenous infants and children are hospitalised with rotavirus gastroenteritis
about 3 to 5 times more commonly than their non-Indigenous peers, are younger
at hospitalisation, and have a longer duration of stay (an average of 5 days,
compared with 2 days for non-Indigenous infants).12,20,21,23
Immunocompromised children and adults, such as those with congenital
immunodeficiency, or post haematopoietic or solid organ transplantation, are at
increased risk of severe, prolonged and even fatal rotavirus gastroenteritis.1,24,25
Rotavirus is an important cause of nosocomial gastroenteritis,26-30 and can also
cause disease in adults, especially among those caring for children and those
residing in aged care facilities.1,31,32
Figure 4.17.1: Rotavirus-coded hospitalisations per month, Australia, 2001 to 201017
1200
National Immunisation Program
1000
Number
800
600
400
200
0
Jan-01 Jan-02 Jan-03 Jan-04 Jan-05 Jan-06 Jan-07 Jan-08 Jan-09 Jan-10
Month
4.17 ROTAVIRUS
age group11,12 and affecting 3.8% of all children (1 in 27) by the age of
5 years. In addition to hospitalisations, an estimated 115 000 children <5 years
of age visited a GP, and 22 000 children required an emergency department
visit due to rotavirus.11,13 On average, there was 1 death attributed to rotavirus
each year in Australia, but this is likely to be a minimum estimate.13 Following
the introduction of rotavirus vaccines to the NIP in 2007, substantial reductions
(>70%) in both rotavirus-specific and all-cause hospital presentations for
gastroenteritis have been reported (Figure 4.17.1).14-17 Emergency department
visits for acute gastroenteritis have also declined, as have rotavirus
notifications.18,19
4.17.4 Vaccines
Two oral rotavirus vaccines are available in Australia, and their efficacy and
safety in the prevention of rotavirus gastroenteritis have been extensively
evaluated.33-39 Both are live attenuated vaccines administered orally to infants,
but the component vaccine viruses differ. The human rotavirus vaccine,
Rotarix (GlaxoSmithKline), is a live attenuated vaccine containing one strain
of attenuated human rotavirus (G1P1A[8] strain). Rotarix protects against
non-G1 serotypes on the basis of other shared epitopes. A pentavalent vaccine,
RotaTeq (CSL Limited/Merck & Co Inc), contains five humanbovine rotavirus
reassortants with the human serotypes G1, G2, G3, G4 and P1A[8] and the bovine
serotypes G6 and P7.
In middle- and high-income countries, a course of vaccination with either Rotarix
or RotaTeq prevents rotavirus gastroenteritis of any severity in approximately
70% of recipients and prevents severe rotavirus gastroenteritis and rotavirus
hospitalisation for 85 to 100% of recipients for up to 3 years.33,34,40,41 Vaccination
is also highly effective in preventing emergency department and clinic/GP
visits.33,40 Overall, in pre-market clinical trials, rotavirus vaccination prevented
around half (4258%) of hospital admissions for acute gastroenteritis of any
cause in young children, suggesting that rotavirus is responsible for more
gastroenteritis than detected using routine testing and admission practices.33,34,40
post-marketing studies in the United States and Australia have confirmed high
vaccine effectiveness and impressive reductions in both rotavirus-coded and allcause gastroenteritis hospitalisations.15,19,42-46 Reductions have also been observed
in age groups not eligible for vaccination, suggesting that herd protective effects
are also likely to exist for rotavirus vaccines.15,19,45
Although more modest estimates of efficacy have been reported in resource-poor
settings,36-38,47 post-marketing evaluation in the middle income countries Mexico
and Brazil have revealed substantial reductions in diarrhoea-related mortality
since vaccine introduction.48,49 Studies of Rotarix during consecutive epidemics in
Central Australia gave generally lower and wide-ranging vaccine effectiveness
estimates, which require further investigation.46,50 Considering the uniqueness
of the remote Australian setting, these results should not be extrapolated to
elsewhere in Australia, where the weight of evidence indicates a substantial
reduction in the burden of rotavirus disease following vaccine introduction. To
date, there has been no convincing evidence of important differences between the
two vaccines with regard to protective efficacy against different serotypes.33,34,39
RotaShield, a tetravalent rhesus-reassortant vaccine, which was licensed in the
United States (but not elsewhere) in 199899, was subsequently associated with
intussusception (IS, an uncommon form of bowel obstruction in young children)
in approximately 1 in 10 000 vaccine recipients.51 The pathogenesis of RotaShieldassociated IS has not been determined. The greatest risk of IS occurred within 3
to 14 days after the 1st dose, with a smaller risk after the 2nd dose.51,52 There is
evidence suggesting that when the 1st dose of RotaShield was given at >3 months
Vaccine viruses replicate in the intestinal mucosa and can be shed in the stool of
vaccine recipients, particularly after the 1st dose. Vaccine virus shedding is more
common with Rotarix and is detected in the stool a week after vaccination in up
to 80% of 1st dose recipients, and in up to 30% of 2nd dose recipients.58,59 RotaTeq
is only shed after the 1st dose (in up to 13% of recipients).33 In one study of 80
sets of twins, transmission of Rotarix was observed to occur from 15 vaccinated
infants to their unvaccinated twin,60 indicating that transmission of vaccine virus
to unvaccinated contacts is likely to occur, but the clinical implication of this has
not been studied (see 4.17.10 Precautions below).
Adventitious DNA fragments of porcine circoviruses have been detected in both
Rotarix and RotaTeq vaccines. However, porcine circoviruses have never been
shown to cause illness in humans and are considered non-pathogenic.
Rotarix GlaxoSmithKline (live attenuated RIX4414 human rotavirus
strain, type G1P1A[8]). Each 1.5mL monodose pre-filled oral
applicator or squeezable tube contains 106.0cell culture infectious
dose 50% (CCID50) of the RIX4414 strain; di-sodium adipate;
Dulbeccos Modified Eagle Medium; sterile water. Manufacture
involves exposure to bovine-derived material.
RotaTeq CSL Limited/Merck & Co Inc (live attenuated human
bovine reassortant rotavirus strains, types G1, G2, G3, G4 and
P1A[8]). Each 2.0mL monodose pre-filled dosing tube contains a
minimum dose level of at least 2.0x106 infectious units of each of
the rotavirus reassortants G1, G2, G3, G4 and P1A[8]; sodium citrate;
sodium phosphate monobasic monohydrate; sodium hydroxide;
polysorbate 80; cell culture medium. Manufacture involves exposure
to bovine-derived material.
4.17 ROTAVIRUS
of age, the risk of IS was increased.52 The current rotavirus vaccines (Rotarix and
RotaTeq) differ in composition to RotaShield, which was more reactogenic.53-55
The large-scale safety studies of Rotarix and RotaTeq included approximately
140 000 infants, and found the risk of IS in vaccine recipients to be similar to that
of placebo recipients, and less than that estimated for RotaShield.33,34 A metaanalysis of clinical trial data also did not find evidence of an increased risk of
IS among vaccine recipients.39 The clinical trials of Rotarix and RotaTeq limited
administration of the 1st dose of vaccine to infants under 14 and 12 weeks of age,
respectively, and did not give subsequent doses to infants beyond 24 weeks for
Rotarix and 32 weeks for RotaTeq.33,34 There are no data from clinical trials on
the use of rotavirus vaccines given outside the recommended dosing age ranges.
While clinical trials excluded an association between Rotarix or RotaTeq and IS
of the magnitude associated with RotaShield, post-marketing studies in Australia
and in Mexico indicate that a smaller increase in the absolute risk of IS might
exist, particularly post dose 1 (see 4.17.11 Adverse events below).56,57


Rotavirus vaccines are for oral administration only. Under no circumstances
should rotavirus vaccines be injected.
Rotarix is recommended for use in a 2-dose course in infants and upper age
limits apply; see Table 4.17.1. The liquid formulation is presented as a clear,
colourless liquid contained within an oral applicator (syringe-type applicator
with a plunger stopper or a squeezable tube). The 1.5mL dose of vaccine should
be administered orally from the oral applicator onto the inside of the infants
cheek. Rotarix does not require reconstitution or dilution.
RotaTeq is recommended for use in a 3-dose course in infants and upper
age limits apply; see Table 4.17.1. It is supplied in a container consisting of a
squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct
oral administration of the 2mL dose onto the inside of the infants cheek. RotaTeq
does not require reconstitution or dilution. RotaTeq is a pale yellow, clear liquid
that may have a pink tint.
There are limited data available on the safety of administering higher than
the recommended dose of rotavirus vaccines or the efficacy of a partially
administered dose(s). If most of an oral rotavirus vaccine dose has been spat
out or vomited within minutes of administration, a single repeat dose can be
administered during the same visit. If an infant regurgitates or vomits only a
small part of a vaccine dose, it is not necessary to repeat the dose. Therefore, the
regurgitated (and incomplete volume) dose is still considered as the valid dose.

Rotavirus vaccines can be co-administered with other vaccines included on the
NIP schedule at 2 and 4 months of age (Rotarix) or 2, 4 and 6 months of age
(RotaTeq). The available evidence from clinical trials suggests co-administration
of oral rotavirus vaccines is safe and effective and does not interfere with
the immune response to other vaccine antigens (DTPa, Hib, IPV, hepB, and
pneumococcal conjugate vaccines).58,59,62
There are no restrictions on the timing of administration of any other live
vaccines in relation to rotavirus vaccines, including BCG or oral poliomyelitis
vaccine (OPV), for example, in infants who have received OPV overseas. Delay of
rotavirus vaccination for 4 weeks following vaccination with BCG or vice versa is
not necessary.
Interchangeability of rotavirus vaccines
Infants
Administration of a course of oral rotavirus vaccination is recommended for
all infants in the first half of the 1st year of life. Vaccination of older infants and
children is not recommended as there are theoretical concerns regarding use in
older age groups (see 4.17.4 Vaccines above). Vaccination should occur at either 2
and 4 months of age (Rotarix), or 2, 4 and 6 months of age (RotaTeq), according
to the following schedules and upper age limits (see Table 4.17.1). The 1st dose of
either rotavirus vaccine can be given as early as 6 weeks of age, where necessary
(see Table 4.17.1). If the 1st dose is given at 6 weeks of age, the next scheduled
rotavirus vaccine dose(s) should still be given according to the age limits
specified for dosing in Table 4.17.1 below.
Rotarix (human monovalent rotavirus vaccine)
The vaccination course of Rotarix consists of 2 doses, at 2 and 4 months of age.

The 1st dose should be given between 6 and 14 weeks of age (i.e. prior to turning
15 weeks old), and the 2nd dose should be given by 24 weeks of age (i.e. prior to
turning 25 weeks old). The interval between the 2 doses should not be less than
4 weeks.
RotaTeq (pentavalent humanbovine reassortant rotavirus vaccine)
The vaccination course of RotaTeq consists of 3 doses, at 2, 4, and 6 months of age.

The 1st dose should be given between 6 and 12 weeks of age (i.e. prior to turning
13 weeks old), and all doses should be given by 32 weeks of age (i.e. prior to
turning 33 weeks old). The interval between doses should be at least 4 weeks.
4.17 ROTAVIRUS
Completion of a course of rotavirus vaccine should be with vaccine from the

same manufacturer whenever possible. There are no studies that address the
interchangeability of the two available rotavirus vaccines. However, if either
dose 1 or 2 of vaccine is given as RotaTeq, a 3rd dose of either rotavirus vaccine
should be given, provided that the upper age limit and inter-vaccine interval, as
defined in Table 4.17.1, are met.
Table 4.17.1: Upper age limits for dosing of oral rotavirus vaccines
Doses
Age of
routine oral
administration
Recommended age limits

for dosing
1st
dose
2nd
dose
3rd
dose
Rotarix
2 oral doses
(GlaxoSmithKline) (1.5mL/dose)
2 and
4 months
614*
weeks
1024*
weeks
N/A
4 weeks
RotaTeq (CSL
Limited/Merck
& Co Inc)
2, 4 and
6 months
612
weeks
1032
weeks
1432
weeks
4 weeks
3 oral doses
(2mL/dose)
Minimum
interval
between
doses
* The upper age limit for receipt of the 1st dose of Rotarix is immediately prior to turning
15 weeks old, and the upper age limit for receipt of the 2nd dose is immediately prior to turning
25 weeks old.
The upper age limit for receipt of the 1st dose of RotaTeq is immediately prior to turning
13 weeks old. The 2nd dose of vaccine should preferably be given by 28 weeks of age to allow
for a minimum interval of 4 weeks before receipt of the 3rd dose. The upper age limit for the 3rd
dose is immediately prior to turning 33 weeks old. For infants presenting for their 2nd dose after
reaching 29 weeks of age, a 2nd and final dose can be given, provided the upper age limit of
32 weeks (immediately prior to turning 33 weeks old) has not been reached.
For infants in whom the 1st dose of rotavirus vaccine is inadvertently

administered at an age greater than the suggested cut-off (i.e. after the 14th week
of age for Rotarix or the 12th week of age for RotaTeq), the remaining vaccine
doses should be administered as per the schedule, providing the minimum
interval between doses can be maintained within the recommended age limits
for subsequent doses. The timing of the 1st dose should not affect the safety and
efficacy of the 2nd and 3rd doses.6 Infants who develop rotavirus gastroenteritis
before receiving the full course of rotavirus vaccination should still complete
the full 2- or 3-dose schedule (dependent on the brand of vaccine), because one
rotavirus infection only provides partial immunity.6
Older infants
Vaccination of older infants, children or adults is not recommended. Infants
should commence the course of rotavirus vaccination within the recommended
age limits for the 1st dose and doses should not be given beyond the upper age
limits for the final dose of the vaccine course (see Infants above). The incidence
of severe rotavirus infection decreases with increasing age and the benefit and
safety profile of rotavirus vaccination in older infants and children has not been
established.
Preterm infants
Vaccination of preterm infants using either rotavirus vaccine is indicated at a
chronologic age (without correction for prematurity) of at least 6 weeks, if the
infant is clinically stable. Preterm infants (born at <37 weeks gestation) appear
to be at increased risk of hospitalisation from viral gastroenteritis.63 In clinical
trials, RotaTeq or placebo was administered to 2070 preterm infants (2536 weeks
See also 4.17.10 Precautions below for other special risk groups and hospitalised
infants.

There are no restrictions on the infants consumption of food or liquid, including
breast milk, either before or after vaccination with either rotavirus vaccine.6,62
Infants living in households of pregnant women can receive rotavirus vaccines.
Most pregnant women will have pre-existing immunity to rotavirus, but
protection from transmission of wild-type infection through the vaccination of
infant contacts may benefit adults, including pregnant women, and outweighs
any theoretical concern regarding exposure to vaccine viruses.
The contraindications to rotavirus vaccines are:
anaphylaxis following a previous dose of either rotavirus vaccine
anaphylaxis following any vaccine component
previous history of intussusception or a congenital abnormality that may
predispose to IS
The risk of recurrence of IS unrelated to rotavirus vaccination is in the order
of 10%.66 In addition, certain congenital malformations affecting the gut
(e.g. Meckels diverticulum) increase the risk of IS. Because of the possible
association of rotavirus vaccination with an increased risk of IS (see 4.17.11
Adverse events below), it is considered prudent to withhold administration of
rotavirus vaccines to an infant with a previous history of IS or with a known
uncorrected congenital malformation associated with increased risk of IS.
severe combined immunodeficiency (SCID) in infants
Case reports from the United States67-69 indicate prolonged vaccine virusassociated gastrointestinal disease following receipt of rotavirus vaccines
among infants with SCID. Because these infants are unlikely to generate a
protective immune response to vaccination and because of potential harm,
rotavirus vaccines are contraindicated for infants with SCID. For infants
with less severe forms of immunocompromise, the risk of vaccine-associated
disease is likely to be less than the risk of natural infection (see 4.17.10
Precautions below).
4.17 ROTAVIRUS
gestational age; median 34 weeks) who experienced rates of adverse events after
vaccination similar to matched placebo recipients.6 Efficacy against rotavirus
gastroenteritis of any severity appeared comparable to efficacy in full-term
infants (73%; 95% CI: 2 to 95%).64 These conclusions would also be expected
to apply to Rotarix vaccine, which appears safe and immunogenic in preterm
infants.65 If standard infection control precautions are maintained, administration
of rotavirus vaccine to hospitalised infants, including hospitalised preterm
infants, would be expected to carry a low risk for transmission of vaccine viruses.
4.17.10 Precautions
Infants with acute gastroenteritis
Infants with moderate to severe acute gastroenteritis should not be vaccinated
until after recovery from their acute illness. Infants with mild gastroenteritis
(including mild diarrhoea) can be vaccinated. The use of rotavirus vaccines has
not been studied in infants with acute gastroenteritis.
Infants with moderate to severe illness

As with other vaccines, infants with a moderate to severe illness should be
vaccinated after recovery. In addition to the factors mentioned above, this
avoids superimposing potential adverse events related to vaccination with the
concurrent illness.
Infants with underlying conditions predisposing to severe rotavirus

gastroenteritis
Conditions predisposing to severe or complicated rotavirus gastroenteritis
include metabolic disorders and chronic gastrointestinal disease, such as
Hirschsprungs disease, malabsorption syndromes or short gut syndrome.1
Data on the safety of live rotavirus vaccines among such infants is limited. In
one report, RotaTeq was reported to be tolerated in 8 of 9 infants with highoutput ileostomies, while 1 infant experienced an increase in ileostomy losses.70
However, because of the greater risk of serious rotavirus disease, the benefits
from vaccination are expected to outweigh the risk in these infants.
Infants who are immunocompromised

There are theoretical concerns that vaccine-associated gastrointestinal disease
could occur in immunocompromised infants who receive rotavirus vaccines, and
infants with the most severe forms of immunocompromise (SCID) should not
receive rotavirus vaccine (see 4.17.9 Contraindications above). However, the risk
for those infants with less severe immunocompromise may be less than the risk
from natural infection. The risks and benefits of vaccination should be considered
in the context of the infants specific immunocompromise with appropriate
specialist advice6 (see 3.3.3 Vaccination of immunocompromised persons).
Rotavirus vaccines have been administered to HIV-infected infants in clinical
trial settings.36-38 Specific data on the safety and efficacy of rotavirus vaccines in
these infants are limited, but suggest that the vaccines are safe and immunogenic
in HIV-infected, but clinically stable, children.71,72 (See also 3.3.3 Vaccination
of immunocompromised persons and Table 3.3.4 Categories of immunocompromise
in HIV-infected persons, based on age-specific CD4+ counts and percentage of total
lymphocytes.) There are no data on the use of rotavirus vaccines in infants born to
women who have received immunosuppressive therapy in pregnancy (see Use
of immunosuppressive therapy during pregnancy in 3.3.2 Vaccination of women
who are planning pregnancy, pregnant or breastfeeding, and preterm infants).
Infants living in households with people who are immunocompromised
Recent administration of antibody-containing blood products

Infants who have recently received antibody-containing blood products and are
at an eligible age should be vaccinated. The interval between vaccination and
receipt of the blood product should be as long as possible, but without delaying
administration of vaccine beyond the suggested age limits for dosing (as per
Table 4.17.1 above). This recommendation for maximising the interval between
receipt of antibody-containing blood products and rotavirus vaccination is based
on theoretical concern that passively acquired antibody to rotavirus may interfere
with vaccine immunogenicity.6
Hospitalised infants
Administration of rotavirus vaccine to hospitalised infants, including premature
infants, is likely to carry a low risk for transmission of vaccine viruses if
standard infection control precautions are maintained. Provided that the infant
is medically stable, vaccination should not be delayed, particularly if the delay
would result in an infant being beyond the upper age limit for vaccination (see
4.17.7 Recommendations above). If a recently vaccinated child is hospitalised for
any reason, no precautions other than routine standard precautions need be
taken to prevent the spread of vaccine virus in the hospital setting.

Intussusception
Although clinical trials of the two available vaccines did not find an association
between vaccination and intussusception (IS)39 (see 4.17.4 Vaccines above), one
post-marketing study in Australia found evidence of a 4- to 5-fold increase in
the risk of IS in the 7 days following the 1st dose of either Rotarix or RotaTeq.56
However, no overall increase in the risk of IS was detectable over the first
9 months of life.56 A similar apparent increase in risk for IS following the 1st dose
of Rotarix has been observed in Mexico, and a smaller increase after the 2nd dose
of Rotarix in Brazil.57 A study in the United States found no increased risk of IS
following RotaTeq; however, the study was limited by small numbers, which
reduced power to determine a low range risk increase.73 A subsequent Australian
study estimated the increased risk of IS to be approximately 9-fold in the first
4.17 ROTAVIRUS
Infants living in households with immunocompromised persons should be

vaccinated. In general, immunocompromised household members are afforded
protection by vaccination of young children in the household and this is
considered to outweigh the risk of transmitting vaccine virus shed in stools to the
immunocompromised household member. However, there have been no studies
to specifically address this question.6 Hand washing and the careful disposal of
soiled nappies are likely to minimise any risk of vaccine transmission to other
household members. (See also 3.3.3 Vaccination of immunocompromised persons.)
7 days after dose 1, and 2-fold in the first 7 days after dose 2 of either vaccine.74
The baseline risk of intussusception for Australian infants is around 80 cases per
100 000 infants.75 The increased risk of IS following rotavirus vaccination, from
the most recent Australian study, is estimated as approximately 6 additional
cases of intussusception among every 100 000 infants vaccinated, or 14 additional
cases per year in Australia.74 This estimate assumes that infants in which
an episode of IS occurs shortly after vaccination would not have otherwise
experienced a natural episode of intussusception; however, this cannot be
determined from current data. Importantly, studies from both Australia14-17 and
overseas57 have demonstrated the substantial impact of vaccination in preventing
rotavirus morbidity and mortality (see also 4.17.3 Epidemiology above). Rotavirus
vaccines continue to be recommended for use on the basis of this positive benefit
to risk profile.76 Immunisation providers should inform parents and carers of the
rare risk of intussusception and how to be alert for the signs and symptoms of
the condition.
Rotavirus vaccine should not be given to an infant who has had a confirmed
intussusception because there may be an increased risk of the condition recurring
(see 4.17.9 Contraindications above).
Other adverse events

No significant increase in post-vaccination vomiting, diarrhoea or fever has
been reported during follow-up of several thousand recipients of Rotarix
compared to those who were unvaccinated.39,77 Detailed follow-up of 11 700
recipients of RotaTeq or placebo reported no increase in fever or irritability in
the week after vaccination among vaccinated infants, but a small increase in
the incidence of vomiting (7% versus 5%) and diarrhoea (10% versus 9%).78
Vomiting and diarrhoea have not emerged as important adverse events following
immunisation in post-marketing surveillance of rotavirus vaccines.
Infants who report an episode of diarrhoea or vomiting following vaccination
should still receive subsequent rotavirus vaccine doses, as required and age
eligible. The potential causes of diarrhoea/vomiting following vaccination
include: gastroenteritis unrelated to rotavirus vaccination or infection (e.g.
another viral agent); natural rotavirus infection (as vaccination is neither
immediately protective nor 100% protective against all disease); or symptoms
from vaccine virus replication (less likely). If rotavirus is detected by routine stool
testing on a recently vaccinated infant, a positive test result can represent either
natural infection or vaccine virus (as vaccine virus shedding occurs commonly
after vaccination (see 4.17.4 Vaccines above). Specific testing is required to
differentiate between vaccine virus and natural infection; however, this is rarely
clinically indicated.
The product information for RotaTeq states that in the event that a dose of
vaccine is spat out or vomited post vaccination, a replacement dose should not
be given. The ATAGI recommends instead that if most of a dose is spat out or
vomited then a single replacement dose may be given (see 4.17.6 Dosage and
administration above.)
References
4.17 ROTAVIRUS
The product information for Rotarix states that the vaccine should not be
administered to subjects with any chronic gastrointestinal disease. The ATAGI
recommends instead that pre-existing chronic gastrointestinal disease is not a
contraindication to rotavirus vaccination, with the exception of those conditions
that may predispose to IS (see 4.17.9 Contraindications and 4.17.10 Precautions
above).
4.18 RUBELLA
4.18.1 Virology
Rubella is an enveloped togavirus, genus Rubivirus. The virus has an RNA
genome and is closely related to group A arboviruses, but does not require
a vector for transmission. It is relatively unstable, and is inactivated by lipid
solvents, trypsin, formalin, extremes of heat and pH, and light.1

Rubella is generally a mild and self-limiting infectious disease, spread
from person to person by respiratory secretions, possibly including aerosol
transmission.1,2 It causes a transient, generalised, erythematous, maculopapular
rash; lymphadenopathy involving the post-auricular and sub-occipital glands;
and, occasionally, arthritis and arthralgia. Other complications, such as
neurological disorders and thrombocytopenia, may occur but are rare. Clinical
diagnosis is unreliable since the symptoms are often fleeting and can be caused
by other viruses; in particular, the rash is not unique to rubella and may be
absent.1,2 Up to 50% of rubella virus infections are subclinical or asymptomatic.1
A history of rubella should, therefore, not be accepted without serological
evidence of previous infection.1 The incubation period is 14 to 21 days, and the
period of infectivity is from 1 week before until 4 days after the onset of the rash.2
Rubella infection in pregnancy can result in fetal infection, causing congenital
rubella syndrome (CRS) in a high proportion of cases. Up to 90% of infants
born to women who had rubella infection in the first trimester of pregnancy
have abnormalities (often multiple) characteristic of CRS.3-5 The risk of damage
declines to 10 to 20% by 16 weeks gestation. After this stage of pregnancy,
fetal damage is rare but has been reported up to 20 weeks gestation.3 The
characteristics of CRS include intellectual disabilities, cataracts, deafness, cardiac
abnormalities, intrauterine growth retardation, and inflammatory lesions of
the brain, liver, lungs and bone marrow.3 Any combination of these defects
may occur, but defects that commonly occur alone following infection after
the first 8 weeks of pregnancy are deafness and pigmentary retinopathy. Some
infected infants may appear normal at birth, but defects, especially sensorineural
deafness, may be detected later.6
Rubella infection has been reported in some persons who already have either
natural or vaccine-induced antibody.3 Occasional cases of CRS after reinfection in
pregnancy have been documented. However, fetal damage is very rare in cases of
infection in women in whom antibody has previously been detected.4,7-9
4.18.3 Epidemiology
Evidence suggests that endemic rubella is well controlled in Australia.10 The
incidence of rubella has fallen rapidly since vaccine registration, and notifications
of rubella have been low since high vaccine coverage was achieved with the
National Measles Control Campaign in late 1998 and then maintained.10 Since
2003, rubella notifications in Australia have been less than 0.3 per 100 000. There
has been a shift in the age distribution of cases, with comparatively more cases
seen in older age groups, particularly the 2529 years age group.10
There has also been a significant increase in the percentage of pregnant women
immune to rubella (e.g. in New South Wales from 82% in 1971 to 96% in 1983).20
Based on a study conducted in Melbourne in 2000, it was estimated that only
2.5% of women of child-bearing age in Australia were seronegative.21 However,
susceptibility was higher among certain groups of women, particularly overseasborn women (see Women of child-bearing age, including post-partum women
in 4.18.7 Recommendations below).21
Young adult males may not be immune to rubella, because they did not receive
a measles-mumps-rubella (MMR) vaccine.22 The MMR vaccination program for
all adolescents replaced the rubella program for girls in 1993/94.11 A serosurvey
conducted in 1999 showed that only 84% of males aged 1418 years (compared to
95% of females) and 89% of males aged 1949 years (compared to 98% of females)
were immune to rubella.22 For this reason, young adult males, as well as females,
who do not have a documented history of receipt of 2 doses of MMR vaccine
should be vaccinated (see 4.18.7 Recommendations below). This is both for their
own protection and to prevent transmission of the infection in the community.
Goals for the elimination of rubella and CRS have been set by a number of
World Health Organization (WHO) regions, and elimination has been declared
by the Pan American Health Organization.23 The WHO Western Pacific Region
has set goals for increased rubella and CRS control efforts, with a number
of member states yet to incorporate rubella vaccination into their routine
schedule.24 As with elimination of measles, rubella and CRS elimination
requires continued strengthening of immunisation and surveillance efforts,
particularly identification of rubella virus genotypes to confirm the absence of
an endemic strain.25
4.18 RUBELLA
Rubella vaccines have been registered in Australia since 1970, and mass
vaccination of schoolgirls commenced in 1971.1,11 Non-pregnant, seronegative
adult women were also vaccinated. These programs were successful and there
was a significant reduction in the incidence of CRS from 1977.12-14 Successful
vaccination campaigns and high vaccination coverage resulted in no cases of
congenital rubella syndrome occurring in infants of Australian-born mothers
between 1998 and 2002. However, 5 cases resulting from infection acquired
outside of Australia were reported during this time.15 In 2003, 2 cases of CRS
occurred in Australian-born mothers from infection that occurred in Australia,16
which reinforces the need for high vaccination coverage of women of childbearing age. Between 2004 and 2008, 2 confirmed cases of CRS were reported in
Australia, in children whose mothers were born outside Australia.17-19
4.18.4 Vaccines
Monovalent rubella vaccine is not available in Australia. Rubella vaccination
is provided using either MMR or measles-mumps-rubella-varicella (MMRV)
vaccines. Two quadrivalent combination vaccines containing live attenuated
measles, mumps, rubella and varicella viruses (MMRV) are registered in
Australia.
A single dose of rubella vaccine produces an antibody response in over 95% of
vaccine recipients, but antibody levels are lower than after natural infection.3,7,8
A 2nd dose aims to confer immunity in those who fail to seroconvert to the 1st
dose. Vaccine-induced antibodies have been shown to persist for at least 16 years
in the absence of endemic disease.7,8,26,27 Protection against clinical rubella appears
to be long-term in those who seroconvert.3
Combination MMRV vaccines have been shown, in clinical trials, to produce
similar rates of seroconversion to all four vaccine components compared with
MMR and monovalent varicella vaccines administered concomitantly at separate
injection sites.28-31
Trivalent measlesmumpsrubella (MMR) vaccines


Jeryl Lynn strain], rubella virus [Wistar RA 27/3 strain] and varicella-



The dose of Priorix (MMR) vaccine for both children and adults is 0.5mL, to be
The dose of M-M-R II (MMR) vaccine for both children and adults is 0.5mL, to
be given by SC injection.
For children <14 years of age, the dose of MMRV vaccine is 0.5mL, to be given
by SC injection. Priorix-tetra may also be given by IM injection.33
4.18 RUBELLA
zoster virus [Oka strain]). Lyophilised pellet in a monodose vial with


pneumococcal conjugate vaccine),34 using separate syringes and injection sites.
parenteral vaccines, they should be given at least 4 weeks apart.

For further information on the recommendations for MMR and MMRV vaccines,
The principal aim of rubella vaccination is to prevent congenital rubella
syndrome by stopping the circulation of rubella virus in the community.
Susceptible pregnant women will continue to be at risk of rubella infection in
pregnancy until the transmission of rubella virus is interrupted by continued
high-level coverage of rubella-containing vaccine.
A history of rubella is not a contraindication to vaccination. Persons who
are already immune to rubella have no increased risk of side effects from
vaccination.3,7

early as 9 months of age in high-risk circumstances (see 4.9 Measles).
If MMR vaccine is given at <12 months of age, there is still a need for 2 vaccine
doses to be administered at 12 months of age (see 4.9 Measles).
Children
Two doses of rubella-containing vaccine are recommended for all children. The
The 2nd dose of rubella-containing vaccine is recommended to be given routinely

at 18 months of age as MMRV vaccine. This is to commence from July 2013, once
MMRV vaccine(s) are available under the NIP (see Table 4.9.1 in 4.9 Measles and
Table 4.22.1 in 4.22 Varicella). The recommended age for administration of the
2nd dose of rubella-containing vaccine will be moved down from 4 years of age,
to provide earlier 2-dose protection against measles, mumps and rubella, and to
improve vaccine uptake (see 4.18.3 Epidemiology above).
12 months of age); however, parents/carers should be advised regarding
the small but increased risk of fever and febrile seizures (compared with that
expected following MMR vaccine).

Two doses of rubella-containing vaccine are recommended for all non-immune
adolescents and adults (see 4.9 Measles). All persons born during or since 1966
who are 18 months of age (or, until catch-up following the move of the 2nd
NIP dose of measles-containing vaccine to 18 months of age is completed, are
4 years of age) should have documented evidence of 2 doses of MMRcontaining vaccine (administered at least 4 weeks apart with both doses
administered at 12 months of age) or have serological evidence of protection
for measles, mumps and rubella.
It is particularly important to ensure that women of child-bearing age are
immune to rubella (see Women of child-bearing age, including post-partum
women below).
It is recommended that all males born during or after 1966 (particularly those
born from 1966 up to the 1990s) have their vaccination records reviewed to
ensure they have received 2 doses of MMR vaccine, as they are more likely, than
females, to have not received 2 doses of rubella-containing vaccine (see 4.18.3
Epidemiology above).
Healthcare workers and those who work with children

All healthcare workers and persons working with children, born during or
since 1966, either without vaccination records or seronegative upon screening,
should receive 2 doses of MMR vaccine, both for their own protection and to
4.18 RUBELLA
(see Table 4.9.1 in 4.9 Measles and Table 4.22.1 in 4.22 Varicella). (See also 4.9.11
Adverse events in 4.9 Measles and 4.22.11 Adverse events in 4.22 Varicella.)
avoid the risk of transmitting rubella to pregnant women35 (see 3.3 Groups with
special vaccination requirements, Table 3.3.7 Recommended vaccinations for persons at
increased risk of certain occupationally acquired vaccine-preventable diseases).
Women of child-bearing age, including post-partum women

Every effort should be made to identify and immunise non-pregnant
seronegative women of child-bearing age (see Serological testing for immunity
to rubella below). The following women are more likely to be seronegative to
rubella: women born overseas (especially in Asia, Pacific islands, sub-Saharan
Africa and South America) who entered Australia after the age of routine
vaccination; Indigenous women living in rural and remote regions; non-English
speaking women; women over the age of 35 years; and Australian-born Muslim
women.12,13,21,36-38
Seronegative women should be given MMR vaccine and advised to avoid
pregnancy for 28 days after vaccination. Vaccinated women should be tested
for seroconversion 6 to 8 weeks after vaccination (see Serological testing for
immunity to rubella below). Women who have negative or very low antibody
levels after vaccination should be revaccinated. However, if antibody levels
remain low after a 2nd documented vaccination, it is unlikely that further
vaccinations will improve this.3 Further testing and vaccination is not usually
warranted; however, consultation with the laboratory that performed the
serological testing may also be helpful (see also Serological testing for immunity
to rubella below). Negative serology after 2 documented doses of rubellacontaining vaccine may represent a false negative (i.e. an antibody titre too low
to be detected using routine commercial assays).
Although 2 doses of MMR vaccine are routinely recommended, if rubella
immunity is demonstrated after receipt of 1 dose of a rubella-containing vaccine,
no further dose is required, unless indicated by subsequent serological testing
(see Serological testing for immunity to rubella below) or if indicated for
protection against measles and mumps (see 4.9 Measles and 4.11 Mumps).
Women found to be seronegative on antenatal testing for rubella immunity
should be vaccinated after delivery and before discharge from the maternity
unit, as discussed above. These women should be tested for rubella immunity 6
to 8 weeks following vaccination.1,7 (See also Serological testing for immunity to
rubella below.)
Serological testing for immunity to rubella

Serological testing for immunity to rubella after routine vaccination of children
is not recommended. However, serological testing for rubella immunity can be
performed in cases where a history of natural immunity or 2 doses of vaccine
administration is uncertain. It is particularly important to ensure that women
of child-bearing age are immune to rubella (see Women of child-bearing age,
including post-partum women above).
All women of child-bearing age should be advised by a medical practitioner

of the result of their antibody test, as it is a clinically significant test.39 Women
should be screened for rubella antibodies shortly before every pregnancy, or
early in the pregnancy, or if pregnancy is contemplated, irrespective of a previous
positive rubella antibody result.3,14 Very occasionally, errors may result in patients
who are seronegative being reported as seropositive. Specimens from pregnant
women are required to be stored until the completion of the pregnancy for
parallel serological testing if required.40

Rubella-containing vaccines are contraindicated in pregnant women
(see 4.18.9 Contraindications below). Pregnancy should be avoided for 28 days
after vaccination.41
MMR vaccines can be given to breastfeeding women. The rubella vaccine
virus may be secreted in human breast milk, and rare cases of transmission of
vaccine virus through breast milk have been reported. However, symptoms
in the newborn have been absent or mild.42-44 Post-partum vaccination of
women without evidence of rubella immunity need not be delayed because of
breastfeeding.
There is no risk to pregnant women from contact with recently vaccinated
persons. The vaccine virus is not transmitted from vaccinated persons to
susceptible contacts.1
4.18 RUBELLA
A number of commercial assays for testing immunity to rubella are available.

These vary according to the method used to determine the positive cut-off
value (the WHO cut-off is 10IU/mL, but, at present, there is no recommended
Australian minimal level). Available data support the presumption that an
antibody level found by use of a licensed assay to be above the standard positive
cut-off for that assay can be considered evidence of past exposure to rubella
virus.7 Rubella vaccine induces immune responses that are similar in quality, but
lesser in quantity, than those after natural disease.3 Measurement of antibody by
commercial assays is not a perfect correlate of protection in vaccinated persons.3
While on the one hand, those with low levels of vaccine-induced antibodies
are often protected, conversely, reinfection may take place in some individuals
with measurable antibodies. If a person is found to be rubella IgG seronegative,
vaccination should be provided according to the recommendations above.
information is provided. In addition, expert consultation and referral of sera to
a reference laboratory are recommended if there is difficulty interpreting results,
particularly for women of child-bearing age (see Women of child-bearing age,
including post-partum women above).

MMR and MMRV vaccines are contraindicated in persons who have had:
anaphylaxis following a previous dose of any MMR-containing vaccine

Measles-, mumps-, and rubella-containing vaccines contain live
immunocompromised. Thus, MMR-containing vaccines are contraindicated in
the following groups:
Persons immunocompromised due to HIV/AIDS. MMR vaccination of
asymptomatic HIV-infected persons >12 months of age with an age-specific
CD4+ count of 15% may be considered45-48 (see HIV-infected persons
in 3.3.3 Vaccination of immunocompromised persons). Since studies have not
been performed using combination MMRV vaccines in asymptomatic HIVinfected persons or persons with an age-specific CD4+ count of 15%, it is
recommended that only MMR vaccine (and monovalent VV, see 4.22 Varicella)
be considered for use in this setting.47,49-51
immunocompromise (see 3.3.3 Vaccination of immunocompromised persons)
Persons receiving high-dose systemic immunosuppressive therapy,
such as chemotherapy, radiation therapy or oral corticosteroids. MMRcontaining vaccines are contraindicated in persons taking high-dose oral
attenuated vaccines after corticosteroid therapy has been discontinued for at
least 1 month52 (see 3.3.3 Vaccination of immunocompromised persons).
See also 3.3 Groups with special vaccination requirements and 4.22 Varicella for more
information.
Pregnant women
See also 4.18.8 Pregnancy and breastfeeding above.
Rubella-containing vaccines are contraindicated in pregnant women.
This is due to the theoretical risk of transmission of the rubella component of the
vaccine to a susceptible fetus. However, no evidence of vaccine-induced CRS has
been reported.1 Active surveillance in the United States, the United Kingdom and
4.18.10 Precautions
For additional precautions related to MMR and MMRV vaccines, see 4.9 Measles
and 4.22 Varicella.


Administration of a MMR or MMRV vaccine should be delayed after
to measles, mumps, rubella and varicella vaccination may be impaired.7,55,56
MMR-containing vaccines should not be given for between 3 and 11 months
following the administration of immunoglobulin-containing blood products.
The interval between receipt of the blood product and vaccination depends on
the amount of immunoglobulin in each product, and is indicated in 3.3 Groups
with special vaccination requirements, Table 3.3.6 Recommended intervals between
either immunoglobulins or blood products and MMR, MMRV or varicella vaccination.55
immunoglobulin and other blood products.
MMR or MMRV vaccines.
MMR vaccine may be administered concomitantly with, or at any time in
immunoglobulin does not interfere with the antibody response to vaccine.1,3,8

following vaccination with rubella-containing vaccines, unless the benefits
administered within this interval, the vaccinated person should either be
4.18 RUBELLA
Germany indicates that no case of vaccine-induced congenital rubella syndrome

occurred among more than 500 women inadvertently vaccinated with rubella
vaccine during pregnancy, whose pregnancies continued.53 In an Iranian study
performed after mass vaccination with a measlesrubella vaccine, 117 susceptible
women were inadvertently vaccinated while pregnant or became pregnant
within 3 months after vaccination. There were no CRS-related abnormalities
among the infants born to these women.54 Based on this evidence, the vaccine
cannot be considered to be teratogenic, and termination of pregnancy following
inadvertent vaccination is not indicated.1,8 (See also 3.3.2 Vaccination of women who
are planning pregnancy, pregnant or breastfeeding, and preterm infants.)
revaccinated later at the appropriate time following the product (as indicated in
Table 3.3.6), or be tested for immunity 6 months later and then revaccinated if
seronegative.
Rh (D) immunoglobulin (anti-D) may be given at the same time in different sites
with separate syringes or at any time in relation to MMR vaccine, as it does not
interfere with the antibody response to the vaccine.

Mild adverse events such as fever, sore throat, lymphadenopathy, rash, arthralgia
and arthritis may occur following MMR vaccination.1,7 Symptoms most often
begin 1 to 3 weeks after vaccination and are usually transient.
Thrombocytopenia (usually self-limiting) has been very rarely associated with
the rubella or measles component of MMR vaccine, occurring in 3 to 5 per 100 000
doses of MMR vaccine administered.7,57-59 This is considerably less frequent than
after natural measles, mumps and rubella infections.59
For further information on adverse events related to MMR and MMRV vaccines,
4.18.12 Public health management of rubella

Rubella is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of rubella, including
management of cases of rubella and their contacts, should be obtained from state/
territory public health authorities (see Appendix 1 Contact details for Australian, state
and territory government health authorities and communicable disease control).
Rubella-containing vaccine does not provide protection if given after exposure to
rubella.7 However, if the exposure did not result in infection, the vaccine would
induce protection against subsequent infection. Normal human immunoglobulin
(NHIG) has been shown not to be of value in post-exposure prophylaxis for
rubella.7 However, NHIG may be recommended in certain circumstances (see Use
of normal human immunoglobulin in pregnant women exposed to rubella below).
Suspected rubella contacts

All contacts of persons with suspected rubella infection should be identified,
especially those who are pregnant (see Pregnant women with suspected rubella
or exposure to rubella below).
Contacts >12 months of age without adequate proof of immunity should receive
1 dose of MMR vaccine (or MMRV vaccine, if appropriate). This will not prevent
rubella disease if already exposed. If vaccination is refused, the contact should
avoid further contact with cases until at least 4 days after onset of the rash in the
case. Seronegative women of child-bearing age should be vaccinated and tested

for seroconversion 6 to 8 weeks after vaccination (see 4.18.7 Recommendations
above).
Testing for rubella infection

All cases of suspected rubella infection should be laboratory tested and false
positive results excluded (see Serological testing for immunity to rubella in
4.18.7 Recommendations above).
Acute rubella infection is indicated by the presence of rubella IgM or a 4-fold or
greater increase in rubella IgG. Rubella IgM may not appear until a week after
clinical symptoms. Sera for testing should be taken 7 to 10 days after onset of
illness and repeated 2 to 3 weeks later. The most recent date of potential exposure
should be obtained, if possible, to calculate the potential incubation period. As
some patients may have more than one exposure to a person with a rubella-like
illness, and because exposure may occur over a prolonged period, it is important
to ascertain the dates of the first and last exposures.60 Testing for infection can
also be done, particularly early in the course of a clinical illness, using virusdetection methods, such as nucleic acid amplification testing (PCR).60
Infected persons should be excluded from school/work/institution and should
avoid contact with women of child-bearing age for at least 4 days after the onset
of the rash.60
Pregnant women with suspected rubella or exposure to rubella

All pregnant women with suspected rubella or exposure to rubella should
be serologically tested (for IgM and IgG), irrespective of a history of prior
vaccination, clinical rubella or a previous positive rubella antibody result (for
more details, see Testing for rubella infection above). Testing is essential because
of the serious consequences of the infection, the rash of rubella is not diagnostic,
asymptomatic infection can occur, and the diagnosis requires confirmation by
laboratory tests.3,7,8 In addition, infection has been reported in women who have
previous evidence of antibody.7
Serologic specimens should include information regarding the date of the
last menstrual period and the date of presumed exposure (or date of onset of
symptoms).60 If the woman has an antibody titre below the protective level, or a
low level of antibodies and remains asymptomatic, a second specimen should be
collected 28 days after the exposure (or onset of symptoms) and tested in parallel
with the first. Alternatively, if the woman develops symptoms/signs of rubella
infection, a second serum specimen should be tested as soon as possible. A third
blood specimen may be required in some circumstances.8 Testing for infection
4.18 RUBELLA
Exposed healthcare workers without adequate proof of immunity should be

excluded from work for 21 days from exposure or for at least 4 days after the
onset of rash.60
can also be done, particularly early in the course of a clinical illness, using virusdetection methods, such as nucleic acid amplification testing (PCR).60
Pregnant women should be counselled to restrict contact with persons with
confirmed, probable or suspected rubella for 6 weeks (2 incubation periods).60
Counselling of pregnant women with confirmed rubella regarding the risk to the
fetus should be given in conjunction with the womans obstetric service.
Use of normal human immunoglobulin in pregnant women exposed to rubella

Post-exposure prophylaxis with normal human immunoglobulin (NHIG) does
not prevent infection in non-immune contacts and is, therefore, of little value
for protection of susceptible contacts exposed to rubella.7 However, it may
prolong the incubation period. If given to non-immune pregnant contacts, this
may marginally reduce the risk to the fetus. It may also reduce the likelihood of
clinical symptoms in the mother. In such cases, IM administration of 20mL of
NHIG within 72 hours of rubella exposure might reduce, but will not eliminate,
the risk for rubella.60 Serological follow-up of recipients is essential, and should
continue for up to 2 months.
There is some evidence to suggest that, in outbreak situations, pre-exposure
NHIG may be effective in preventing infection in women who are likely to be
pregnant, and its use may be indicated for such women with low antibody titres
in high-risk occupations.61

The product information for MMR and MMRV vaccines recommends that
women of child-bearing age should be advised not to become pregnant for
3 months after vaccination. The ATAGI instead recommends avoiding
pregnancy for 28 days after vaccination.41
For further information on MMR and MMRV vaccines, see 4.9 Measles and
4.22 Varicella.
References
4.19 TETANUS
4.19.1 Bacteriology

Tetanus is an acute, often fatal, disease caused by the toxin produced by
C.tetani. The neurotoxin acts on the central nervous system to cause muscle
rigidity with painful spasms. The disease usually occurs after an incubation
period of 3 to 21 days (range 1 day to several months), with a median time
of onset after injury of 10 days. Generally, a shorter incubation period is
associated with a more heavily contaminated wound, more severe disease
and a worse prognosis. Generalised tetanus, the most common form of the
disease, is characterised by increased muscle tone and generalised spasms.
Early symptoms and signs include increased tone in the masseter muscles
(trismus, or lockjaw), dysphagia, and stiffness or pain in the neck, shoulder
and back muscles. Some patients develop paroxysmal, violent, painful,
generalised muscle spasms. A constant threat during generalised spasms is
reduced ventilation, apnoea or laryngospasm. The patient may be febrile,
although many have no fever; mental state is unimpaired. Sudden cardiac
arrest sometimes occurs, but its basis is unknown. Other complications include
pneumonia, fractures, muscle rupture, deep vein thrombophlebitis, pulmonary
emboli, decubitus ulcers and rhabdomyolysis. Death results from respiratory
failure, hypertension, hypotension or cardiac arrhythmia.
Tetanus is uncommon in people who have received 4 or more doses of a tetanuscontaining vaccine and in those who received their last dose within 10 years.1,2
However, cases have been reported3,4 and clinicians should consider tetanus
when there are appropriate symptoms and signs, irrespective of the persons
vaccination status. A high level of diagnostic awareness of tetanus is particularly
important in the elderly in industrialised countries, including Australia, as most
deaths occur in people over 70 years of age, especially women, and may be
associated with apparently minor injury.1,2,5
Neonatal tetanus is usually associated with generalised symptoms, and fatal
if left untreated. It usually occurs following contamination of the umbilical
cord stump. Neonatal tetanus was effectively eliminated in Australia and other
developed countries over a century ago. Introduction of maternal immunisation
during pregnancy with tetanus toxoid has seen neonatal tetanus almost
eliminated in developing countries.6
4.19 TETANUS
Tetanus is caused by Clostridium tetani, a motile, non-capsulated, Gram-positive

rod that forms endospores. Spores of the bacillus are found in manured soil and
can enter wounds. Once in a wound site, the bacillus can grow anaerobically.
C.tetani produces a potent protein toxin, which has two components,
tetanospasmin (a neurotoxin) and tetanolysin (a haemolysin).
4.19.3 Epidemiology
In Australia, tetanus is rare, occurring primarily in older adults who have
never been vaccinated or who were vaccinated in the remote past. There
were 24 notified cases of tetanus during 20012007, but 156 hospitalisations
(July 2000June 2007) where tetanus was coded as the principal diagnosis.5,7,8
This discrepancy suggests under-notification. During 20012006, there were
3 deaths recorded from tetanus.5,7,8 The case-fatality rate in Australia is about
2%. Effective protection against tetanus can be provided only by active
immunisation. This is because the amount of tetanus toxin required to produce
clinical symptoms is too small to induce a protective antibody response; second
cases of tetanus in unimmunised persons have been recorded. Tetanus vaccine
was introduced progressively into the childhood vaccination schedule after
World War II. The effectiveness of the vaccine was demonstrated in that war; all
Australian servicemen were vaccinated against tetanus and none contracted the
disease. As tetanus can follow apparently trivial, even unnoticed wounds, active
immunisation is the only certain protection.1 A completed course of vaccination
provides protection for many years.
4.19.4 Vaccines
Tetanus toxoid is available in Australia only in combination with diphtheria
and other antigens.
The acronym DTPa, using capital letters, signifies child formulations of
diphtheria, tetanus and acellular pertussis-containing vaccines. The acronym
dTpa is used for formulations that contain substantially lesser amounts
of diphtheria toxoid and pertussis antigens than child (DTPa-containing)
formulations; dTpa vaccines are usually used in adolescents and adults.
Tetanus vaccination stimulates the production of antitoxin. Hence, vaccination
does not prevent growth of C.tetani in contaminated wounds, but protects
against the toxin produced by the organism. The immunogen is prepared by
treating a cell-free preparation of toxin with formaldehyde, thereby converting
it into the innocuous tetanus toxoid. Tetanus toxoid is usually adsorbed onto an
adjuvant, either aluminium phosphate or aluminium hydroxide, to increase its
immunogenicity. Antigens from Bordetella pertussis, in combination vaccines, also
act as an effective adjuvant.
Complete immunisation (a 3-dose primary schedule and 2 booster doses) induces
protective levels of antitoxin throughout childhood and into adulthood but, by
middle age, about 50% of vaccinated persons have low or undetectable levels.9-11
A single dose of tetanus toxoid produces a rapid anamnestic response in such
persons.12-15
PT, 25g FHA, 8g PRN, 40 D-antigen units inactivated poliovirus
units type 3 (Saukett), adsorbed onto aluminium hydroxide; traces of
formaldehyde, polysorbate 80, polymyxin and neomycin.
and streptomycin.
neomycin.
4.19 TETANUS

FIM 2+3; 1.5mg aluminium phosphate; 3.4mg phenoxyethanol.
Reduced antigen formulations for adults, adolescents and children aged

10 years
ADT Booster CSL Limited/Statens Serum Institut (dT; diphtheriatetanus). Each 0.5mL monodose vial or pre-filled syringe contains
2IU diphtheria toxoid and 20IU tetanus toxoid, adsorbed onto
0.5mg aluminium as aluminium hydroxide.
phenoxyethanol as preservative; traces of formaldehyde and
glutaraldehyde.
and streptomycin.
glycine.


The dose of all tetanus-containing vaccines is 0.5mL, to be given by IM injection.
Do not mix DTPa- or dTpa-containing vaccines or dT vaccine with any other
vaccine in the same syringe, unless specifically registered for use in this way.
Tetanus toxoid is given in combination with diphtheria toxoid and acellular
pertussis as DTPa vaccine. The recommended 3-dose primary schedule is at 2,
4 and 6 months of age. The 1st dose can be given as early as 6 weeks of age, due
to the high morbidity and occasional mortality associated with pertussis in very
young infants. If the 1st dose is given at 6 weeks of age, the next scheduled doses
should still be given at 4 months and 6 months of age (see 4.12 Pertussis).
A booster dose of tetanus-containing vaccine, usually provided as DTPaIPV, is recommended at 4 years of age, but can be given as early as 3.5 years.
For this booster dose, all brands of DTPa-containing vaccines are considered
interchangeable.
Where required, DTPa-containing vaccines can be given for catch-up for either
the primary doses or booster dose in children aged <10 years (see 2.1.5 Catch-up).

A 2nd booster dose is recommended for adolescents between 10 and 17 years of
age, using the reduced antigen content dTpa. The optimal age for administering
this dose is 1113 years, due to waning immunity (particularly the pertussis
antibody responses) following the 1st booster dose recommended at 4 years
of age. (See also 4.12 Pertussis.) This 2nd booster dose of tetanus-containing
vaccine is also essential for maintaining immunity to tetanus (and diphtheria and
pertussis) into adulthood.
It is recommended to use the reduced antigen content dTpa for booster doses.
However, when necessary, dT can also be used for the booster dose or, if
necessary, for the primary dT course, in persons aged 10 years (see 4.19.14
Variations from product information below).
vaccination for tetanus, see 2.1.5 Catch-up.
4.19 TETANUS
Adults
Booster vaccination
All adults who reach the age of 50 years without having received a booster dose
of dT in the previous 10 years should receive a further tetanus booster dose. This
should be given as dTpa, to also provide protection against pertussis (see 4.12
Pertussis). This stimulates further production of circulating tetanus antibodies at
an age when waning of diphtheria and tetanus immunity is commencing in the
Australian population.9 Travellers to countries where health services are difficult
to access should be adequately protected against tetanus before departure. They
should receive a booster dose of dT (or dTpa if not given previously) if more than
10 years have elapsed since the last dose of dT-containing vaccine.
of a dT-containing vaccine.
Primary vaccination
Persons who have not received any tetanus vaccines are also likely to have
missed diphtheria vaccination. Therefore, 3 doses of dT should be given at
minimum intervals of 4 weeks, followed by booster doses at 10 and 20 years after
the primary course. One of these 3 doses (preferably the 1st) should be given as
dTpa, to also provide additional protection against pertussis. In the event that
dT vaccine is not available, dTpa can be used for all primary doses. However,
this is not recommended routinely because there are no data on the safety,
immunogenicity or efficacy of dTpa in multiple doses for primary vaccination.
vaccine requiring catch-up, see 2.1.5 Catch-up.

Although dT or dTpa vaccines are not routinely recommended for pregnant
women, they can be given under certain circumstances, such as for management
of a tetanus-prone wound (see 4.19.9 Tetanus-prone wounds below) or to prevent
pertussis in pregnant women and their newborns (see 4.12 Pertussis).17
dT or dTpa vaccines can be given to breastfeeding women.
4.19.9 Tetanus-prone wounds

The definition of a tetanus-prone injury is not straightforward, as tetanus
may occur after apparently trivial injury, such as from a rose thorn, or with no
history of injury. It is for this reason that all wounds other than clean, minor
cuts are considered tetanus-prone. However, there are certain types of wounds
that are more likely to favour the growth of tetanus organisms. These include
compound fractures, bite wounds, deep penetrating wounds, wounds containing
Adults who have sustained injuries deemed to be tetanus-prone (all wounds

other than clean minor cuts) should receive a booster dose of dT if more than
5 years have elapsed since the last dose of tetanus-containing vaccine (see
Table 4.19.1). As an alternative to dT vaccine after a tetanus-prone wound,
adults can receive dTpa vaccine (see 4.12 Pertussis) to also provide additional
protection against pertussis.19 In children <10 years of age, this dose of vaccine
should be given as DTPa or a DTPa-combination vaccine, consistent with the
childs vaccination history and the recommended schedule. For details on the
management of children who have missed doses in the recommended schedule,
see 2.1.5 Catch-up. If there is any doubt about the adequacy of previous tetanus
immunisation in a person who has a tetanus-prone wound, TIG must be given
as soon as possible, as well as tetanus toxoid-containing vaccine, to provide both
immediate passive and active protection (see Table 4.19.1). The recommended dose
for TIG is 250IU, given by IM injection, as soon as practicable after the injury.
If more than 24 hours have elapsed, 500IU should be given. Persons with a
significant humoral immune deficiency may not have developed or maintained
adequate immunity to tetanus, despite vaccination, and require TIG for tetanusprone wounds.
Clean minor cuts are not categorised as tetanus-prone wounds and, for these
wounds, TIG is unnecessary, independent of previous tetanus vaccination
history.
Information regarding accessing tetanus immunoglobulin (for intramuscular
use for management of tetanus-prone wounds, or intravenous tetanus
immunoglobulin for the treatment of clinical tetanus) should be obtained from
the Australian Red Cross Blood Service (see Part 5 Passive immunisation). For
further information on TIG see 4.19.13 Public health management of tetanus below.
General measures for treatment of tetanus-prone wounds20-25

Whatever the immune status of a person with a tetanus-prone wound, local
disinfection and, where appropriate, surgical treatment of tetanus-prone wounds,
must never be omitted. Antibiotic prophylaxis is not indicated for the prevention
of tetanus; however, the use of antibiotics (such as penicillin, amoxycillin +
clavulanate, or metronidazole) for preventing other bacterial infection of the
wound is a matter for clinical judgment.
4.19 TETANUS
foreign bodies (especially wood splinters), wounds complicated by pyogenic

infections, wounds with extensive tissue damage (e.g. contusions or burns) and
any superficial wound obviously contaminated with soil, dust or horse manure
(especially if topical disinfection is delayed more than 4 hours). Reimplantation
of an avulsed tooth is also a tetanus-prone event, as minimal washing and
cleaning of the tooth is conducted to increase the likelihood of successful
reimplantation. Persons who inject drugs are also at risk of tetanus, particularly
if skin popping is practised.18 Appropriate tetanus prophylaxis measures
in wound management, including use of tetanus immunoglobulin (TIG), are
outlined in Table 4.19.1.
Table 4.19.1: Guide to tetanus prophylaxis in wound management

History
of tetanus
vaccination
Time since
last dose
Type of wound
3 doses
<5 years
Clean minor
wounds
All other wounds
NO
NO
NO
NO
Clean minor
wounds
All other wounds
NO
NO
YES
NO
Clean minor
wounds
All other wounds
YES
NO
YES
NO
Clean minor
wounds
All other wounds
YES
NO
YES
YES
3 doses
3 doses
510 years
>10 years
<3 doses or
uncertain
DTPa, DTPacombinations,
dT, dTpa, as
appropriate
Tetanus
immunoglobulin*
(TIG)
* The recommended dose for TIG is 250IU, given by IM injection, as soon as practicable after the
injury. If more than 24 hours have elapsed, 500IU should be given. Because of its viscosity, TIG
should be given to adults using a 21 gauge needle. For children, it can be given slowly using a
23 gauge needle.
All wounds, other than clean minor wounds, should be considered tetanus-prone. For more
detail, see 4.19.9 Tetanus-prone wounds above.
Individuals with a humoral immune deficiency (including HIV-infected persons who have
immunodeficiency) should be given TIG if they have received a tetanus-prone injury, regardless
of the time since their last dose of tetanus-containing vaccine.
P
ersons who have no documented history of a primary vaccination course (3 doses) with a
tetanus toxoid-containing vaccine should receive all missing doses and must receive TIG. See
2.1.5 Catch-up.
The only absolute contraindications to tetanus-containing vaccines are:
anaphylaxis following a previous dose of any tetanus-containing vaccine
If a person has a tetanus-prone wound and has previously had a severe adverse
event following tetanus vaccination, alternative measures, including the use of
tetanus immunoglobulin, can be considered.
4.19.11 Precautions
Administration of more than 1 dose of a tetanus-containing vaccine in a 5-year
period in previously immunised adults had previously been thought to be
associated with an increased risk of injection site reactions. However, recent

Mild discomfort or pain at the injection site persisting for up to a few days is
common. Uncommon general adverse events following dT vaccine include
headache, lethargy, malaise, myalgia and fever. Anaphylaxis, urticaria and
peripheral neuropathy occur very rarely. Brachial neuritis (inflammation of a
nerve in the arm, causing weakness or numbness) has been described following
the administration of tetanus toxoid-containing vaccines, with an estimated
excess risk of approximately 0.51 in 100 000 doses in adults.30,31 For specific
adverse events following combination vaccines containing both tetanus and
pertussis antigens, see 4.12 Pertussis.
4.19.13 Public health management of tetanus

Tetanus is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of tetanus, including
management of cases of tetanus, should be obtained from state/territory public
Tetanus Immunoglobulin-VF (human; for intramuscular use) CSL
Limited. 160mg/mL immunoglobulin (mainly IgG) prepared from
human plasma containing high levels of antibody to the toxin of
Clostridium tetani. Single vials contain 250 IU of human tetanus
antitoxin, with the actual volume stated on the label on the vial. Also
contains glycine.
For information on the definition and management of tetanus-prone wounds,

see 4.19. 9 Tetanus-prone wounds and Table 4.19.1 above. To access tetanus
immunoglobulin (for intramuscular use for management of tetanus-prone
wounds, or intravenous tetanus immunoglobulin for the treatment of clinical
tetanus), contact the Australian Red Cross Blood Service (see Part 5 Passive
immunisation).

4.19 TETANUS
studies indicate that the adverse reactions to a single dose of dTpa are similar
in adults and adolescents, whether administered shortly (18 months) or at a
longer interval after a previous dose of a vaccine containing tetanus/diphtheria
toxoids.26-29 (See also 4.12 Pertussis.)
<10 years of age.
The product information for ADT Booster states that this vaccine is indicated
for use as a booster dose only in children aged 5 years and adults who have
previously received at least 3 doses of diphtheria and tetanus vaccines. The
ATAGI recommends instead that, where a dT vaccine is required, ADT Booster
can be used, including for primary immunisation against diphtheria and tetanus
(for any person 10 years of age).
The product information for Boostrix, Boostrix-IPV, Infanrix hexa and
Infanrix IPV states that these vaccines are contraindicated in children with
encephalopathy of unknown aetiology or with neurologic complications
occurring within 7 days following a vaccine dose. The ATAGI recommends
The product information for Adacel Polio states that this vaccine is not indicated
following a tetanus-prone wound. The ATAGI recommends instead that Adacel
Polio can be administered following a tetanus-prone wound.
References
4.19 TETANUS
The product information for Adacel and Boostrix states that there is no
pertussis in adults; however, the ATAGI recommends that pregnant or postpartum women can receive a booster dose every 5 years and that other adults in
contact with infants and/or at increased risk from pertussis can receive a booster
dose every 10 years.
4.20 TUBERCULOSIS
4.20.1 Bacteriology
Tuberculosis (TB) is caused by organisms of the Mycobacterium tuberculosis
complex (M.TB complex), which are slow-growing, aerobic, acid-fast bacilli.
The M.TB complex consists of Mycobacterium tuberculosis, M.bovis, M.microti,
M.canetti and M.africanum,1 of which M.tuberculosis is the cause of almost all TB
in Australia.2

As infection is usually air-borne, lung disease is the most common form of
tuberculosis, accounting for approximately 60% of notified TB cases in Australia.3
Cough, fever, sweats, weight loss and haemoptysis are common symptoms
of pulmonary TB. TB lymphadenitis is the most common extrapulmonary
manifestation, but the disease can occur in any part of the body. Disseminated
disease (miliary TB) and meningeal TB are more common in very young children,
and are among the most serious manifestations of TB disease.1
Most persons infected with M.tuberculosis remain asymptomatic, but there is
a 10% lifetime risk of developing clinical illness (although the risk can vary
depending on age and immune status), sometimes many years after the original
infection. Infants, the elderly and persons who are immunocompromised, due to
drugs or disease or as a result of adverse socioenvironmental circumstances (e.g.
malnutrition, alcoholism), are more prone to rapidly progressive or generalised
infection.1,4
4.20.3 Epidemiology
The World Health Organization (WHO) declared tuberculosis a global emergency
in 1993, and recent reports have reaffirmed the threat to human health.5 It is
estimated that in 2010 there were 8.8 million incident cases of TB globally. The
majority of these cases (81%) were accounted for by 22 high-burden countries,
which all have estimated TB incidences of greater than 40 per 100 000.6
Approximately 1200 cases of TB are notified to Australian health authorities
each year. The annual notification rate for TB has been relatively stable at
approximately 5 to 6 cases per 100 000 population since 1985.2,3 In the southern
states, rates among Indigenous Australians overall are comparable with rates
among Australian-born non-Indigenous Australians; however, in some specific
settings (e.g. in the Northern Territory, Far North Queensland and northern
South Australia) rates are higher in Indigenous Australians3 (see 3.1 Vaccination
for Aboriginal and Torres Strait Islander people). Most TB cases in Australia (over
85%) occur in persons born overseas, particularly those born in Asia, southern
and eastern European countries, Pacific island nations, and north and subSaharan Africa. The rate of TB in the overseas-born population has been slowly
increasing over the past decade.3 The rate of multi-drug resistant (MDR) TB in
Australia has been low (less than 2% of notified cases); however, the proportion
of MDR-TB cases identified has increased in recent years.2,3,7-9 Tuberculosis in

animals (M.bovis) has been eradicated by screening and culling programs.10
4.20.4 Vaccine
BCG vaccine Sanofi Pasteur Pty Ltd (live vaccine prepared from an
attenuated strain of Mycobacterium bovis). 1.5mg lyophilised powder
in a multi-dose vial with separate diluent. Reconstituted vaccine
contains 832x106 colony forming units per mL and monosodium
glutamate 1.5% w/v. May contain trace amounts of polysorbate 80.
Reconstituted volume provides about 10 adult or 20 infant doses.
BCG (bacille Calmette-Gurin) vaccine is a suspension of a live attenuated

strain of M.bovis. Worldwide, there are many BCG vaccines available, but they
are all derived from the strain propagated by the Institute Pasteur, which was
first tested in humans in 1921.12 BCG vaccination probably has little effect on
preventing infection per se, or reactivation among those already infected with
TB, so the role of BCG vaccination in preventing overall transmission is probably
limited.13 However, there is strong evidence that BCG vaccination in infancy
provides greater than 70% protection against severe disseminated forms of TB
disease in young children, including miliary TB and TB meningitis.14-18 TB can be
difficult to diagnose in young children and progression to disseminated TB can
be rapid; they are therefore the primary target for the use of BCG vaccine. The
efficacy of BCG vaccine against pulmonary disease in adults is less consistent
and has ranged from no protection to 80% in controlled trials.19 The greatest
protection has been observed among skin test-negative adults in North America
and Europe, and the lowest among skin test-positive persons in tropical
settings.13 The reason for the wide variation in measured effectiveness is not clear,
but has been attributed to variability in study quality, differences in BCG strains,
host factors such as age at vaccination and nutritional status, and differences
in the prevalence of infection with environmental mycobacteria. The duration
of protection following BCG vaccination has been difficult to measure because
the interval between infection and disease may extend to decades. Benefit from
infant vaccination has been found in studies with follow-up of up to 12 years, but
protection is commonly thought to decline over 10 to 20 years.13 There is evidence
that memory responses persist for up to 10 to 50 years.20-22
4.20 TUBERCULOSIS
Patients who are immunocompromised are at high risk of developing active

TB if they are infected with M.tuberculosis.4,5,11 Screening programs in Australia
concentrate on contacts of notified cases and others at increased risk of TB
infection, including refugees and healthcare workers.
BCG vaccination has been shown to offer some protection against Mycobacterium
leprae, the causative agent of leprosy.23
BCG vaccine is not used in the treatment of tuberculosis disease. BCG may be
used as a therapeutic modality for transitional cell carcinoma of the bladder.

BCG vaccine must be reconstituted by adding the entire contents of the diluent
Reconstituted vaccine is very unstable and must be stored at +2C to +8C and
used within one working session of 4 to 6 hours.

The dose of BCG vaccine in newborns and infants <12 months of age is 0.05mL,
given by intradermal injection.
The dose of BCG vaccine in children 12 months of age and in adults is 0.1mL,
given by intradermal injection.
BCG vaccine is given as a single dose. Due to the lack of evidence, BCG
revaccination is not recommended in any person.
BCG vaccine is available from state/territory tuberculosis services.
Before vaccination
Tuberculin skin test (Mantoux)
All individuals, except infants <6 months of age, should undergo a tuberculin
skin test (TST; Mantoux) before BCG vaccination. A hypersensitivity reaction to
tuberculin purified protein derivative (PPD; Tubersol) used in the TST assists
in the identification of those infected with M.TB. A hypersensitivity reaction
may also occur in those infected with other mycobacteria and those previously
vaccinated with BCG. Only immunocompetent persons who have induration
<5mm following correctly administered and interpreted TST should receive BCG
vaccination. Guidelines to assist in the undertaking and interpretation of TST are
available by contacting local state/territory tuberculosis services.
It should be noted that live viral vaccines inhibit the response to tuberculin and
tuberculin-positive persons may become tuberculin-negative for up to a month
after measles infection.25,26 As such, tuberculin skin testing may be unreliable for
at least 4 weeks after the administration of live viral vaccines.
Interferon-gamma () release assays
Newly available blood tests (Interferon-gamma release assays; IGRAs) are

available for the detection of tuberculosis infection. TST, however, remains
the preferred method of screening for tuberculosis infection, pending further
evaluation of IGRAs. Guidelines for the use of IGRAs in Australia have been
developed by the National Tuberculosis Advisory Committee.27
BCG vaccination procedures
Use a short (10mm) 2627 gauge needle with a short bevel. The risk of
spillage can be minimised by using an insulin syringe to which the needle is
already attached.
Wear protective eye-wear. The person to be vaccinated (and the parent/carer
holding a small child being vaccinated) should also wear protective eye-wear.
Eye splashes may ulcerate; if an eye splash occurs, wash the eye with saline
or water immediately.
Identify the correct injection site. BCG vaccine should be injected into the
skin over the region of insertion of the deltoid muscle into the humerus. This
is just above the midpoint of the upper arm. This site is recommended to
minimise the risk of keloid formation. By convention, the left upper arm is
used wherever possible to assist those who subsequently look for evidence of
BCG vaccination.
Stretch the skin between a finger and thumb and insert the bevel into the
dermis, bevel uppermost, to a distance of about 2mm. The bevel should be
visible through the transparent epidermis.
If the injection is not intradermal, withdraw the needle and try again at a new
site. A truly intradermal injection should raise a blanched bleb of about 7mm
in diameter with the features of peau dorange (the appearance of orange
peel). Considerable resistance will be felt as the injection is given. If this
resistance is not felt, the needle may be in the subcutaneous tissues.
Response to BCG vaccination

In response to BCG vaccination, a small red papule forms and eventually
ulcerates, usually within 2 to 3 weeks of vaccination. The ulcer heals with
minimal scarring over several weeks. There may be swelling and tenderness in
local lymph nodes. While a local reaction represents a normal response to BCG
vaccination, more extensive local reactions are less common (see 4.20. 11 Adverse
events below). Subjects who are given BCG vaccine despite latent or previous
TB infection are likely to experience an accelerated response characterised by
induration within 24 to 48 hours, pustule formation in 5 to 7 days, and healing
within 10 to 15 days.
Clinical trials have not shown a consistent relationship between the size of
tuberculin reactions after BCG vaccination and the level of protection provided.
TST is not recommended to demonstrate immunity after BCG vaccination.28,29
4.20 TUBERCULOSIS
BCG vaccination should only be given by medical or nursing staff who are
trained in BCG vaccination procedures.
BCG is not recommended for routine use in the general population, given the
low incidence of TB in Australia and the variable efficacy reported in adults.
However, some groups are at increased of tuberculosis and BCG vaccination
may be warranted for these persons, based on a risk assessment. BCG should be
specifically considered for the following groups.
Aboriginal and Torres Strait Islander neonates30

In some parts of Australia, the incidence of TB is appreciably higher among
Aboriginal and Torres Strait Islander people than Australian-born nonIndigenous Australians, and BCG is recommended for neonates living in
those regions. State and territory guidelines should be consulted for local
recommendations and the geographic areas where BCG vaccination of
Aboriginal and Torres Strait Islander neonates is conducted (see Appendix 1
communicable disease control). (See also 3.1 Vaccination for Aboriginal and Torres
Strait Islander people.)
Infants born in Australia to migrant parents

TB is rare in infants and young children born in Australia, but infants born to
parents who have migrated from countries with a high TB incidence (i.e. >40 cases
per 100 000 population per year see 4.20.3 Epidemiology above) may be at higher
risk of TB exposure in their early life.31 BCG vaccination of these infants is not
routinely recommended because of the uncertainty of the risks and benefits.
Children who will be travelling to high TB incidence settings

The risk of TB disease in children travelling to countries with a high TB incidence
(i.e. >40 cases per 100 000 population per year see 4.20.3 Epidemiology above)
depends on the age of the child, the duration of stay, and the TB incidence at the
destination. Country-specific incidence data are available from the World Health
Organization.32
The need for BCG vaccination should be assessed for young children,
particularly those aged <5 years, who will be travelling to a country with high
TB incidence for an extended period. This is best discussed with local state/
territory TB services or with a paediatric infectious diseases specialist. BCG
vaccination should ideally occur at least 3 months before departure and therefore
consideration should be given to future travel plans at birth.
Neonates born to parents with leprosy or a family history of leprosy

There is strong evidence that BCG provides some protection against
Mycobacterium leprae.23
Occupational groups

BCG vaccine is contraindicated in pregnant women.
BCG vaccine can be given to breastfeeding women.
BCG is a live vaccine and its use is contraindicated in the following groups:
Persons with known or suspected HIV infection,33 even if asymptomatic
or with normal immune function, because of the risk of disseminated BCG
infection.34,35
Persons treated with corticosteroids or other immunosuppressive therapy,
including monoclonal antibodies against tumour necrosis factor-alpha (TNFalpha) (e.g. infliximab, etanercept, adalimulab). Infants born to mothers
treated with bDMARDS (e.g. TNF-alpha blocking monoclonal antibodies)
in the third trimester of pregnancy frequently have detectable antibodies for
several months and they should not be vaccinated36-38 (see also 3.3 Groups with
special vaccination requirements).
Persons with congenital cellular immunodeficiencies, including specific
deficiencies of the interferon-gamma pathway.
Persons with malignancies involving bone marrow or lymphoid systems (see
also 3.3 Groups with special vaccination requirements).
Persons with any serious underlying illness, including severe malnutrition.
Pregnant women (BCG vaccine has not been shown to cause fetal damage,
but use of live vaccines in pregnancy is not recommended).
Persons who have previously had TB or a large (5mm) reaction to a
tuberculin skin test.
4.20 TUBERCULOSIS
There is some evidence that specific occupational groups are at increased risk of
TB, including embalmers, and healthcare workers likely to encounter patients
with TB (e.g. chest clinic staff) or those involved in conducting autopsies. Due
to the limited evidence of benefit of BCG vaccination in adults and interference
of vaccination with interpretation of TST, routine BCG vaccination of persons
within these occupations is not recommended. In occupational settings, TB
prevention and control should be focused around infection control measures,
employment-based TST screening and therapy for latent TB infection. However,
BCG vaccination should be considered for TST-negative healthcare workers who
are at high risk of exposure to drug-resistant TB, due to the difficulty in treating
drug-resistant infection.
4.20.10 Precautions
For those who would otherwise be candidates for BCG, vaccination should be
deferred in the following groups:
Neonates who are medically unstable, until the neonate is in good medical
condition and ready for discharge from hospital.
Infants born to mothers who are suspected or known to be HIV-positive,
until HIV infection of the infant can be confidently excluded.
Persons with generalised septic skin disease and skin conditions such as
eczema, dermatitis and psoriasis.
Persons being treated for latent TB infection, as the therapy is likely to
inactivate the BCG vaccine.
Persons who have recently received another parenteral live vaccine (e.g.
MMR, MMRV, varicella, zoster and yellow fever vaccines), until 4 weeks have
elapsed, unless these vaccines are given concurrently with the BCG vaccine.
There are no restrictions on the timing of BCG vaccine in relation to oral live
vaccines.
Persons with significant febrile illness, until 1 month after recovery.

The normal reaction to BCG vaccination has been described above (see
4.20.6 Dosage and administration). About 5% of vaccinated persons experience
adverse events. Injection site abscesses occur in 2.5% of vaccinated persons
and lymphadenitis in 1%, while up to 1% require medical attention.39 Gross
suppurative or generalised complications of BCG vaccination have been treated
with anti-tuberculosis drugs; however, there is no consensus on the management
of these complications and specialist advice should be sought from local state/
territory tuberculosis services. Anaphylactic reactions have also been reported.
Keloid formation can occur, but the risk is minimised if the injection is not given
higher than the level of insertion of the deltoid muscle into the humerus. The
overall risk of fatal disseminated infection is extremely low (approximately 1 case
per million vaccinated persons).13
4.20.12 Public health management of tuberculosis

Tuberculosis is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of tuberculosis,
including management of cases of tuberculosis and their contacts, should
References
4.20 TUBERCULOSIS
Although the product information for BCG vaccine specifies that vaccine must
be used within 8 hours of reconstitution, the National Tuberculosis Advisory
Committee (NTAC) guidelines recommend that any unused vaccine is discarded
after a working period of 4 to 6 hours.
4.21 TYPHOID
4.21.1 Bacteriology
Typhoid fever is a clinical syndrome caused by a systemic infection with
Salmonella enterica subspecies enterica serovar Typhi (S.Typhi). Paratyphoid fever,
caused by infection with S.enterica serovar Paratyphi A or B, is similar to, and
often indistinguishable from, typhoid fever.1 The two infections are collectively
known as enteric fever, have largely overlapping geographic distributions, and,
although there is no vaccine specifically targeted against paratyphoid fever,
there is evidence to suggest some cross-protection from the oral live attenuated
typhoid vaccine against Paratyphi B.2-4

Typhoid fever has a usual incubation period of 7 to 14 days (range 3 to 60 days).5
Although clinical presentations of typhoid fever can be quite variable, a typical
case presents with a low-grade fever, dull frontal headache, malaise, myalgia,
anorexia and a dry cough.5 The fever tends to increase as the disease progresses;
constipation (more typically diarrhoea in young children), abdominal tenderness,
relative bradycardia and splenomegaly are common. Complications occur in 10
to 15% of patients and tend to occur in patients who have been ill for more than
2 weeks. The more important complications include gastrointestinal bleeding,
intestinal perforation and typhoid encephalopathy.5
Relapse occurs in up to 10% of patients, usually 2 to 3 weeks after the initial fever
resolves. Chronic asymptomatic biliary carriage of S.Typhi occurs in up to 5% of
patients with typhoid fever, even after treatment. Chronic carriage is defined by
the continued shedding of the organism for longer than 1 year. Carriers serve as
an important reservoir in endemic areas and are of public health significance (e.g.
if a carrier works in the food industry).5
4.21.3 Epidemiology
Humans are the sole reservoir of S.Typhi. It is shed in the faeces of those
who are acutely ill and those who are chronic asymptomatic carriers of
the organism; transmission usually occurs via the ingestion of faecally
contaminated food or water.
The vast majority of typhoid fever cases occur in less developed countries, where
poor sanitation, poor food hygiene and untreated drinking water all contribute
to endemic disease, with moderate to high incidence and considerable mortality.6
Geographic regions with high incidence (>100 cases per 100 000 population
per year) include the Indian subcontinent, most Southeast Asian countries
and several South Pacific nations, including Papua New Guinea. Estimates of
incidence from African countries are more limited. In many regions, particularly
the Indian subcontinent, strains partially or completely resistant to many
antibiotics (including ciprofloxacin) are detected with increasing frequency.7
4.21.4 Vaccines
Monovalent typhoid vaccines
Vivotif Oral CSL Limited/Crucell Switzerland AG (oral live
attenuated typhoid vaccine). Each enteric-coated capsule contains
2x109 viable organisms of attenuated S.Typhi strain Ty21a; gelatin;
ethylene glycol; sucrose. 3 capsules in a blister pack.
Typherix GlaxoSmithKline (purified Vi capsular polysaccharide
vaccine). Each 0.5mL pre-filled syringe contains 25g Vi
polysaccharide of S.Typhi strain Ty2; phenol as preservative;
phosphate buffer.
Typhim Vi Sanofi Pasteur Pty Ltd (purified Vi capsular
polysaccharide vaccine). Each 0.5mL pre-filled syringe contains 25g
Vi polysaccharide of S.Typhi strain Ty2; phenol as preservative;
phosphate buffer.
Combination vaccine that contains S.Typhi

Vivaxim Sanofi Pasteur Pty Ltd (formaldehyde-inactivated hepatitis
A virus [GBM strain] and typhoid Vi capsular polysaccharide).
Supplied in a dual-chamber syringe which enables the two vaccines
to be mixed just before administration. Each 1.0mL dose of mixed
vaccine contains 160 ELISA units of inactivated hepatitis A virus
antigens, 25g purified typhoid Vi capsular polysaccharide
strain Ty2; 0.3mg aluminium as aluminium hydroxide; 2.5L
phenoxyethanol; 12.5g formaldehyde; traces of neomycin, bovine
serum albumin and polysorbate 80.
The attenuated non-pathogenic S.Typhi strain Ty21a was derived by chemical

attenuation of a wild-type strain. Attenuated features of Ty21a include the
absence of the enzyme UDP-galactose-4-epimerase and the Vi capsular
polysaccharide antigen (an important virulence determinant of S.Typhi). These
features partially contribute to the non-pathogenicity and, therefore, the safety of
the oral live vaccine.12
4.21 TYPHOID
In developed countries, typhoid fever is predominantly a travel-related disease,

with a considerably greater risk following travel to the Indian subcontinent
than to other regions.8,9 Those who travel to endemic regions to visit friends and
relatives (e.g. immigrants who travel to their former homelands) appear to be
at considerably greater risk of acquiring typhoid fever than other travellers.8-10
There are typically fewer than 150 cases of typhoid fever reported in Australia
each year, with most following travel to regions with endemic disease.11
The oral vaccine Ty21a strain cannot be detected in faeces more than 3 days
after administration of the vaccine. It stimulates serum IgG, vigorous secretory
intestinal IgA and cell-mediated immune responses.12 Clinical trials, with
different formulations of the vaccine and with a variety of schedules, have
been undertaken in several countries with endemic typhoid fever (Egypt,
Chile, Indonesia). These have documented varying degrees of protection
against the disease.5,12
Parenteral Vi polysaccharide vaccines are produced by fermentation of the
Ty2 strain, followed by inactivation with formaldehyde, and then extraction
of the polysaccharide from the supernatant using a detergent.12 The vaccines
elicit prompt serum IgG anti-Vi responses in 85 to 95% of adults and children
>2 years of age. The vaccines have also been used in clinical trials in endemic
regions (Nepal, South Africa, China), indicating moderate protection
against typhoid fever.5,12 As with oral typhoid vaccine, herd protection of
unvaccinated persons living in areas with moderate coverage of parenteral
vaccine has been demonstrated.13,14
Neither the oral nor the parenteral vaccines have been studied in prospective
clinical trials in travellers to endemic regions. Because many travellers do not
have any naturally acquired immunity, the protection conferred through typhoid
vaccination may be less than that documented in the clinical trials mentioned
above. However, there is circumstantial evidence that the vaccines do provide
protection to travellers to endemic regions,8,9 and that 3-yearly revaccination is
necessary to prolong the protection.15

Because the person to be vaccinated will be responsible for looking after
the course of the oral live attenuated vaccine following purchase, details of
how it should be transported (from the pharmacy to home) and stored in the
refrigerator (at home) must be carefully explained.

Oral live attenuated vaccine
The vaccine is registered for use in persons 6 years of age; it is presented in
a pack of 3 capsules. Each dose (a whole capsule) is the same for both adults
and children.
The vaccination schedule consists of 1 capsule of vaccine on days 1, 3 and 5,
taken 1 hour before food. The capsule must be swallowed whole with water
and must not be chewed, since the organisms can be killed by gastric acid. Do
not give the vaccine concurrently with antibiotics, or other drugs that are active
against Salmonellae. If possible, antibiotics and other relevant drugs should be
delayed for 3 days after the last dose of the vaccine (see 4.21.10 Precautions below).
A 4th capsule taken on day 7 has been shown in one large clinical trial to
result in a lower incidence of typhoid fever compared with 3 doses.12,17
However, giving a 4th dose requires partial use of a second pack.
Oral typhoid vaccine can be administered at the same time as any of the live
parenteral vaccines (including yellow fever vaccine or BCG).12
The oral live attenuated typhoid vaccine should be separated from the
administration of inactivated oral cholera vaccine by an interval of at least
8 hours, and separated from the administration of antibiotics by an interval
of at least 3 days (see 4.21.10 Precautions below).
The oral live attenuated typhoid vaccine may be given concurrently with
mefloquine or with atovaquone/proguanil combination (Malarone)
(see 4.21.10 Precautions below).
Parenteral Vi polysaccharide vaccines

Both monovalent typhoid vaccines (Typherix and Typhim Vi) are registered
for use in persons 2 years of age. The dose of both vaccines is 0.5mL (for both
adults and children), to be given by IM injection.
The dose of the combination typhoid Vi polysaccharide/hepatitis A vaccine
(Vivaxim) is 1mL to be given by IM injection. Vivaxim is registered for use in
persons aged 16 years. (See also 4.4 Hepatitis A.)
Parenteral Vi polysaccharide typhoid vaccines can be given with, or at any

time before or after, other travel vaccines, such as oral cholera or yellow fever
vaccines.
It is recommended that travellers be advised about personal hygiene, food
safety and drinking boiled or bottled water only. They should be advised that
raw (or undercooked) shellfish, salads, cold meats, untreated water and ice (in
drinks) are all potentially high-risk, as are short (day) trips away from higher
quality accommodation venues.

Oral typhoid vaccine is not recommended for use in children aged <6 years.
4.21 TYPHOID
Children aged 6 years and adults
Oral typhoid vaccine in either a 3- or 4-dose schedule is recommended for

children aged 6 years and adults who are:
travelling to endemic regions, where food hygiene may be suboptimal and
drinking water may not be adequately treated
travelling to endemic regions to visit friends and relatives
military personnel
laboratory personnel routinely working with S.Typhi.
The addition of a 4th oral dose, on day 7, is an option as there is evidence that
4 doses provides greater protection.12,17
Revaccination of children aged 6 years and adults
The optimal timing of revaccination against typhoid fever is uncertain and,

therefore, international recommendations vary considerably.5,7,9,12
Where continued exposure to S.Typhi exists (such as occurs with either
prolonged travel or residence in an endemic region) and the oral live attenuated
vaccine was used initially, a repeat 3-dose or 4-dose course can be given 3 years
after a 3-dose course, or 5 years after a 4-dose course.

For further recommendations on the use of the combination typhoid Vi
polysaccharide/hepatitis A vaccine see 4.4 Hepatitis A.
The parenteral typhoid vaccine is not recommended for use in children aged
<2 years.
Children aged 2 years and adults
A single dose of parenteral typhoid vaccine is recommended for children aged

2 years and adults who are:
travelling to endemic regions, where food hygiene may be suboptimal and
drinking water may not be adequately treated
travelling to endemic regions to visit friends and relatives
military personnel
laboratory personnel routinely working with S.Typhi.
Revaccination of children aged 2 years and adults
The optimal timing of revaccination against typhoid fever is uncertain and,

therefore, international recommendations vary considerably.5,7,9,12
Where continued exposure to S.Typhi exists (such as occurs with either
prolonged travel or residence in an endemic region) and the parenteral vaccine
was used initially, revaccinate with the parenteral vaccine every 3 years. See also
4.4 Hepatitis A for more information.

The oral live attenuated typhoid vaccine is contraindicated in pregnant women
(see 4.21.9 Contraindications below).
Parenteral Vi polysaccharide vaccines are not routinely recommended for
pregnant or breastfeeding women, but can be given where vaccination is
considered necessary (see 4.21.7 Recommendations above).
The only absolute contraindications to typhoid vaccines are:
anaphylaxis following a previous dose of any typhoid vaccine

The oral live attenuated vaccine should not be administered to:
children <6 years of age; parenteral Vi polysaccharide vaccine should be
used instead in children 25 years of age
pregnant women; parenteral Vi polysaccharide vaccine should be
used instead
persons who are immunocompromised, including those with known HIV
infection; parenteral Vi polysaccharide vaccine should be used instead
persons taking antibiotics; parenteral Vi polysaccharide vaccine should be
used instead.

The parenteral Vi polysaccharide vaccines should not be administered to
children <2 years of age.
4.21.10 Precautions
The oral live attenuated vaccine strain may be destroyed by gastric acid,
so capsules must be swallowed whole, rather than chewed or opened.
There should be an interval of at least 8 hours between the administration
of the oral live attenuated typhoid vaccine and the inactivated oral cholera
vaccine, as the buffer in the cholera vaccine may affect the transit of the
capsules of oral typhoid vaccine through the gastrointestinal tract.
The oral live attenuated typhoid vaccine may be susceptible to inactivation by
some antibiotics and antimalarial agents, although concurrent administration
of either mefloquine or atovaquone/proguanil combination (Malarone) has not
been shown to interfere with immune responses or efficacy. If the oral vaccine is
4.21 TYPHOID
The oral live attenuated typhoid vaccine can be given to breastfeeding women.
used, it is recommended that vaccination should be timed so that the last dose of
vaccine is administered at least 3 days before starting antibiotics or antimalarial
prophylaxis.

Typhoid vaccines, both oral and parenteral, are associated with very few adverse
events and, when adverse events do occur, they tend to be mild and transient.18

Abdominal discomfort, diarrhoea, nausea, vomiting and rashes have occasionally
been reported.

Local adverse events such as erythema, swelling and pain at the injection site
occur very commonly in 10 to 20% of vaccine recipients. Systemic adverse events
are common and include fever (3% of recipients), malaise and nausea.
4.21.12 Public health management of typhoid fever

Typhoid fever is a notifiable disease in all states and territories in Australia.
Further instructions about the public health management of typhoid fever,
including management of cases of typhoid fever and their contacts, should

The Australian product information for Vivotif Oral live attenuated vaccine
does not mention the use of a 4-dose course of the vaccine for either initial or
repeat vaccination, although this vaccine is registered for use in some other
countries (e.g. Canada and the United States) in a 4-dose schedule. The ATAGI
recommends that a 4-dose course can be given to provide increased protection
against typhoid fever.
The product information for Vivotif Oral live attenuated vaccine does not include
pregnancy among the listed contraindications. The ATAGI recommends that
pregnancy is a contraindication to the oral live attenuated typhoid vaccine.
The product information for Typhim Vi recommends a booster dose every 2 to
3 years, and the product information for Vivotif Oral live attenuated vaccine
recommends a booster every 3 years. The ATAGI also recommends, for those
at continuing risk, revaccination with a dose of parenteral Vi polysaccharide
vaccine every 3 years after a previous dose, or revaccination with a 3- or 4-dose
course of the oral live attenuated vaccine 3 years after a 3-dose course or 5 years
after a 4-dose course.
References
4.22 VARICELLA
4.22.1 Virology

Varicella is a highly contagious infection spread by respiratory secretions,
including aerosol transmission, or from the vesicle fluid of the skin lesions of
varicella or zoster infection.1 Varicella is usually a mild disease of childhood.
However, complications occur in approximately 1% of cases.3 It is more severe
in adults and in persons of any age who are immunocompromised, in whom
complications, disseminated disease and fatal illness can occur.1
The average incubation period is 14 to 16 days (range 10 to 21 days), but may
be longer in persons who are immunocompromised, especially after receipt
of zoster immunoglobulin (ZIG).2 The period of infectivity is from 48 hours
before the onset of rash until crusting of all lesions has occurred.4 A short
prodromal period of 1 to 2 days may precede the onset of the rash, especially
in adults.1,2 In otherwise healthy children, skin lesions usually number between
200 and 500.1,2 Acute varicella may be complicated by secondary bacterial skin
infection, pneumonia, acute cerebellar ataxia (1 in 4000 cases), aseptic meningitis,
transverse myelitis, encephalitis (1 in 100 000 cases) and thrombocytopenia. In
rare cases, it involves the viscera and joints.1
Congenital varicella syndrome has been reported after varicella infection in
pregnancy and may result in skin scarring, limb defects, ocular anomalies
and neurologic malformations.1,5 There is a higher risk to the fetus if maternal
infection occurs in the second trimester compared with infection in the first
trimester (1.4% versus 0.55%).6 Infants with intrauterine exposure also risk
developing herpes zoster in infancy (0.81.7%), with the greatest risk following
exposure in the third trimester.5 Severe neonatal varicella infection can result
from perinatal maternal varicella.7 The onset of varicella in pregnant women
from 5 days before delivery to 2 days after delivery is estimated to result in
severe varicella in 17 to 30% of their newborn infants.1,7
Reactivation of latent VZV as a result of waning cellular immunity results in
herpes zoster (HZ), a localised vesicular rash. HZ can occur at any age, but
is more common in older adults and persons who are immunocompromised.
Complications may include post-herpetic neuralgia and disseminated zoster with
visceral, central nervous system and pulmonary involvement1 (see 4.24 Zoster).
There is no specific therapy for uncomplicated varicella infection. Antiviral
therapy is used in the treatment of complicated or severe varicella, herpes zoster
disease, and disease in persons who are immunocompromised.
4.22 VARICELLA
Varicella-zoster virus (VZV) is a DNA virus within the herpes virus family.1
Primary infection with VZV causes varicella (chickenpox). Following primary
infection, VZV establishes latency in the dorsal root ganglia. Reactivation of the
latent virus manifests as herpes zoster (shingles)2 (see 4.24 Zoster).
4.22.3 Epidemiology
In an unimmunised population in temperate climates, the annual number
of cases of varicella approximates the birth cohort.8 Tropical regions have
a higher proportion of cases in adults. Approximately 5% of cases are
subclinical. A serosurvey conducted in 19971999 found that 83% of the
Australian population were seropositive by 1014 years of age.9 Prior to the
introduction of a varicella vaccination program in Australia, there were about
240 000 cases, 1500 hospitalisations and an average of 7 to 8 deaths each year
from varicella in Australia.10-12 The highest rates of hospitalisation occur in
children <5 years of age.13
In Australia, there was a 69% decline in varicella hospitalisations in children
aged 1.54 years in the first 2.5 years following the inclusion of varicella vaccine
on the NIP in late 2005.14 Declines have also been observed in hospitalisation
rates in other age groups and in general practice consultations.14-16 In the United
States, where universal varicella vaccination has been in place since 1995, there
has been an even greater decline in varicella disease (85%) and hospitalisations
(7088%).17-19 The greatest decline in hospitalisation rates has been in 04-year
olds. However, reductions in hospitalisation rates have also occurred in infants,20
older children and adults, due to herd immunity.17
There has been no evidence of a change in the rates of herpes zoster
incidence, healthcare utilisation or hospitalisations in the United States21,22
or hospitalisations in Australia14,15 attributable to the introduction of the
varicella vaccine, although herpes zoster rates in children have declined in
the United States.23,24
4.22.4 Vaccines
Live attenuated varicella vaccine (VV) is currently available as a monovalent
vaccine. Two quadrivalent combination vaccines containing live attenuated
measles, mumps, rubella and varicella viruses (MMRV) are also registered
in Australia.
All available varicella-containing vaccines are derived from the Oka VZV strain,
but have some genetic differences.25
Monovalent VVs have been available in Australia since 2000, and, since
November 2005, a single dose of VV has been funded under the NIP for all
children at 18 months of age, with a catch-up dose funded for children 10
to <14 years of age who have not received varicella vaccine and who have
not had the disease.26 At the time of implementation of a universal varicella
vaccination program in Australia, a single dose was considered adequate for
protection of infants and children <14 years of age. However, recent data from
the United States suggest that a 2nd dose of varicella-containing vaccine in
children is optimal to provide an immune response more like that acquired after
natural infection, reducing the risk of vaccine failure and increasing population
immunity.27 Vaccine failure, also known as breakthrough varicella, is defined
Post-marketing studies in the United States have estimated the effectiveness of

1 dose of VV in children to be 80 to 85% against any disease and 95 to 98%
against severe varicella.28-32 Although earlier data suggested persistence of
immunity in most healthy vaccine recipients,1 some, but not all, long-term
follow-up studies have shown that rates of vaccine failure increased over time
in 1-dose vaccine recipients. For example, in one study, vaccine failure was
increased 2.6 times in children who received 1 dose of vaccine more than 5 years
previously, compared with those who had received 1 dose of vaccine within
5 years.33 Follow-up from a randomised controlled trial in children 12 months
to 12 years of age, comparing 1 dose with 2 doses of VV over a 10-year period,
showed significantly higher protection with 2 doses (98.3% versus 94.4%).34
Based on current evidence, 2 doses of a varicella-containing vaccine in children
from 12 months of age will minimise the risk of breakthrough varicella (see 4.22.7
Recommendations below).
Healthy adolescents (14 years of age ) and adults require 2 doses of varicella
vaccine, at least 4 weeks apart, as the response to a single dose of VV decreases
progressively as age increases and is insufficient to provide adequate protection.35
Combination MMRV vaccines have been shown in clinical trials, conducted
predominantly in children 12 months to 6 years of age, to produce similar rates
of seroconversion to all four vaccine components compared with MMR and
monovalent varicella vaccines administered concomitantly at separate injection
sites.36-39 In one comparative study assessing seroresponses to a single MMRV
vaccine dose in 1214-month-old children, the seroresponse rates to measles,
mumps and rubella were similar, but varicella seroresponses were lower in
Priorix-tetra recipients than in ProQuad recipients.40 However, the clinical
significance of this is not clear, particularly for MMRV given after MMR vaccine.
Monovalent varicella vaccines (VV)

Varilrix GlaxoSmithKline (live attenuated Oka strain of varicellazoster virus). Lyophilised powder in a monodose vial with separate
diluent. Each 0.5mL reconstituted dose contains 103.3 plaqueforming units (PFU) of attenuated varicella-zoster virus; human
albumin; lactose; neomycin; polyalcohols.
Varivax Refrigerated CSL Limited/Merck & Co Inc (live attenuated
Oka/Merck strain of varicella-zoster virus). Lyophilised powder
4.22 VARICELLA
as a case of wild-type varicella occurring more than 42 days after vaccination.

The majority of cases of breakthrough varicella are mild with fewer lesions than
natural infection. However, breakthrough varicella infections can be contagious,
particularly if many lesions are present.28
reconstituted dose contains 1350PFU of attenuated varicella-zoster

virus; sucrose; hydrolysed gelatin; urea; monosodium glutamate;
residual components of MRC-5 cells; traces of neomycin and bovine
serum.

103.0 cell culture infectious dose 50% (CCID50) of the Schwarz measles
virus, 104.4 CCID50 of the RIT 4385 mumps virus, 103.0 CCID50 of the
Wistar RA 27/3 rubella virus, and 103.3 PFU of Oka varicella-zoster
virus; lactose; neomycin; sorbitol; mannitol.
reconstituted dose contains 103.0 tissue culture infectious dose 50%
(TCID50) of Enders attenuated Edmonston measles virus, 104.3
TCID50 of the Jeryl Lynn B level mumps virus, 103.0 TCID50 of the
Wistar RA 27/3 rubella virus, and 103.99 PFU of Oka/Merck varicella
virus; sucrose; hydrolysed gelatin; urea; sorbitol; monosodium
L-glutamate; human albumin; neomycin; residual components of
MRC-5 cells; bovine serum albumin.

Varicella-containing vaccines are less stable than other commonly used live
viral vaccines, and adherence to storage and reconstitution requirements is very
important. All vaccines must be reconstituted by adding the entire contents of the
diluent to the vial containing the pellet, and shaking until the pellet is completely
dissolved. Available monovalent VVs and MMRV vaccines have different
requirements following reconstitution.
Reconstituted Varilrix vaccine should be used as soon as practicable. If storage is
necessary, hold at ambient temperature for not more than 90 minutes, or at +2C
to +8C for not more than 8 hours.
Reconstituted Varivax Refrigerated vaccine must be used within 2 hours.

The dose of VV and MMRV vaccines is 0.5mL, to be given by SC injection.
Priorix-tetra may also be given by IM injection.42
The minimum interval between doses of varicella-containing vaccine is 4 weeks.

VV and MMRV vaccines can be given at the same time as other live attenuated
parenteral vaccines (e.g. BCG, yellow fever) or other inactivated vaccines
(including DTPa, hepatitis B, Hib, IPV, MenCCV, hepatitis A and pneumococcal
conjugate vaccine),40 using separate syringes and injection sites. If VV or MMRV
vaccine is not given simultaneously with other live attenuated parenteral
vaccines, they should be given at least 4 weeks apart.
If VV is given at the same time as MMR vaccine, they should be given using
separate syringes and injection sites. MMR vaccine and monovalent VV should
not be mixed together prior to injection.
Interchangeability of varicella-containing vaccines

In general, the two brands of varicella vaccine can be considered interchangeable;
that is, the 2nd varicella dose does not have to be of the same brand as the 1st.
The same principle applies to the two available MMRV vaccines,40 although they
are not routinely recommended in a 2-dose schedule.
Children (aged <14 years)
It is recommended that at least 1 dose of a varicella-containing vaccine be
given to all children <14 years of age. One dose of varicella-containing vaccine
is recommended to be given routinely at 18 months of age as either VV or as
MMRV vaccine; see Table 4.22.1. (See also 4.9 Measles.) Prior varicella infection is
not a contraindication and such children can still receive either VV or MMRV, as
appropriate. (See also Serological testing for varicella immunity from infection
and/or vaccination below.) There is no known increase in adverse events from
vaccinating those with pre-existing immunity to one or more of the vaccine
components (see 4.22.11 Adverse events below).
Administration of varicella vaccine from as early as 12 months of age will
provide earlier protection from varicella and can be considered on a case-bycase basis when appropriate, for example, in the context of travel or a varicella
4.22 VARICELLA
Reconstituted Priorix-tetra (MMRV) vaccine should be used as soon as practicable.

If storage is necessary, hold at +2C to +8C for not more than 8 hours.
outbreak. However, note that MMRV vaccine is not recommended for use as the
1st dose of MMR-containing vaccine in children aged <4 years, due to a small
but increased risk of fever and febrile seizures when given as the 1st MMRcontaining vaccine dose in this age group (see 4.9 Measles and 4.22.11 Adverse
events below).
If MMRV is inadvertently administered as dose 1 of MMR-containing vaccine,
the dose does not need to be repeated (providing it was given at 12 months
of age); however, parents/carers should be advised regarding the small but
increased risk of fever and febrile seizures (compared with that expected
following MMR vaccine).
Receipt of 2 doses of varicella-containing vaccine provides increased protection
and minimises the chance of breakthrough varicella in children <14 years of
age.34 However, routine administration of a 2nd dose of varicella-containing
vaccine for children is not included on the NIP schedule. If parents/carers wish
to minimise the risk of breakthrough varicella, administration of 2 doses of
varicella-containing vaccine is recommended (see 4.22.4 Vaccines above). MMRV
vaccine is also suitable for use as the 2nd dose of varicella-containing vaccine
in children <14 years of age. (For further information, see also 4.9 Measles.) The
minimum interval between doses of varicella-containing vaccine in children (and
adults) is 4 weeks.
Table 4.22.1: R
ecommendations for varicella vaccination with (a) monovalent
varicella vaccine (VV) (currently available), and (b) once measlesmumps-rubella-varicella (MMRV) vaccines are available from
July 2013
Vaccines
12 months
(a) Only monovalent varicella
vaccine available
(b) W
hen MMRV vaccine available
(from July 2013)
Schedule point (age)

18 months
4 years
MMR
VV
MMR*
MMR
MMRV
* The 2nd dose of MMR-containing vaccine is recommended to be provided at 18 months of age

to improve 2-dose coverage and protection against measles in young children. However, until
June 2013 the 2nd dose of MMR vaccine is included under the NIP schedule for administration
at 4 years of age. From July 2013, the 2nd dose of MMR vaccine will move to the 18-month NIP
schedule point and be provided as MMRV vaccine.
Adolescents (aged 14 years) and adults

Vaccination is recommended for all non-immune adolescents (14 years of age)
and adults. Every effort should be made to identify and immunise non-pregnant
seronegative women of child-bearing age (see 4.22.2 Clinical features above).
Adolescents (14 years of age) and adults must receive 2 doses of VV to achieve
Serological testing for varicella immunity from infection and/or vaccination

Children who have an uncertain clinical history or no documentation of
age-appropriate varicella vaccination should be considered susceptible and
offered vaccination. Although a reliable history of varicella infection correlates
highly with serological evidence of immunity in young children,44,45 due to the
decreasing incidence of varicella in Australia and reduced familiarity with the
disease, vaccination should be offered, unless confident clinical diagnosis of
prior natural infection is made. Testing of children to assess serologic status
prior to vaccination is generally not recommended. Provided there are no
contraindications, children can safely receive either VV or MMRV vaccine, even if
prior infection with VZV has occurred (see Children (aged <14 years) above).
In older adolescents and adults with a negative history of varicella infection
and no documented history of age-appropriate vaccination, serological testing
before vaccination is more likely to be helpful, as a majority of those with a
negative history are immune, and thus may not require vaccination.46,47 Screening
for varicella immunity (from natural infection) or a past history of vaccination
should be undertaken as part of pre-pregnancy planning and varicella vaccine
given to non-immune women prior to conception.
Testing to check for seroconversion after varicella vaccination is not
recommended. Commercially available laboratory tests are not usually
sufficiently sensitive to detect antibody levels following vaccination, which may
be up to 10-fold lower than levels induced by natural infection.48-50 Protection
(commensurate with the number of vaccine doses received, see 4.22.4 Vaccines
above) should be assumed if a child or adult has documented evidence of receipt
of age-appropriate dose(s) of a varicella-containing vaccine. If serological tests
to investigate existing immunity to varicella are performed, interpretation of the
results may be enhanced by discussion with the laboratory that performed the
test, ensuring the relevant clinical information described above is provided.
Post-exposure vaccination
If varicella-containing vaccines are not contraindicated, vaccination can be
offered to non-immune age-eligible children and adults who have a significant
exposure to varicella or HZ, and wish to be protected against primary infection
4.22 VARICELLA
adequate protection from varicella.35,43 The 2 doses should be administered

at least 4 weeks apart. However, a longer interval between vaccine doses is
acceptable. Lack of immunity to varicella should be based on a negative history
of previous varicella infection and can be supplemented by serological testing for
evidence of past infection (see Serological testing for varicella immunity from
infection and/or vaccination below).
with VZV. (See also 4.22.12 Public health management of varicella below.) Postexposure vaccination is generally successful when given within 3 days, and up
to 5 days, after exposure, with earlier administration being preferable.51-55 MMRV
vaccine can be given to children in this setting, particularly if MMR vaccination is
also indicated (see 4.22.7 Recommendations above).

Vaccination of household contacts of persons who are immunocompromised is
strongly recommended. This is based on evidence that transmission of varicella
vaccine virus strain is extremely rare and it is likely to cause only mild disease
(see 4.22.11 Adverse events below). This compares with the relatively high risk
of severe varicella disease from exposure to wild-type varicella-zoster virus
in persons who are immunocompromised.49,56 If vaccinated persons develop
a rash, they should cover the rash and avoid contact with persons who are
immunocompromised for the duration of the rash. Zoster immunoglobulin
(ZIG) need not be given to an immunocompromised contact of a vaccinated
person with a rash, because the disease associated with this type of transmission
(should it occur) is expected to be mild (see 4.22.12 Public health management of
varicella below).
Healthcare workers, staff working in early childhood education and care, and in
long-term care facilities
Refer to 3.3 Groups with special vaccination requirements, Table 3.3.7 Recommended
vaccinations for persons at increased risk of certain occupationally acquired vaccinepreventable diseases for more information.
Vaccination against varicella is recommended for all non-immune adults, but
especially for all healthcare workers (HCW), staff working in early childhood
education and care, and staff working in long-term care facilities. Persons in
such occupations who have a negative or uncertain history of varicella infection,
and who do not have documentation of 2 doses of varicella vaccine, should
be vaccinated with 2 doses of varicella vaccine or have serological evidence of
immunity to varicella57 (see Adolescents (aged 14 years) and adults above).
Testing to check for seroconversion after VV is not recommended (see Serological
testing for varicella immunity from infection and/or vaccination above).
However, since varicella vaccination is not 100% effective, HCWs and other
carers should still be advised of the signs and symptoms of infection and how to
manage them appropriately according to local protocols if they develop varicella.

Varicella-containing vaccines are contraindicated in pregnant women (see
4.22.9 Contraindications below). Pregnancy should be avoided for 28 days after
vaccination.
Varicella-containing vaccines can be given to breastfeeding women. Most live
vaccines have not been demonstrated to be secreted in breast milk. Women who
Varicella-containing vaccines are contraindicated in persons who have had:
anaphylaxis following a previous dose of any varicella-containing vaccine

Measles-, mumps-, rubella- and varicella-containing vaccines contain live
immunocompromised. Thus, both VV and MMRV vaccines are contraindicated
in the following groups:
Persons immunocompromised due to HIV/AIDS. Vaccination with live
attenuated vaccines can result in a more extensive vaccine-associated rash
or disseminated infection in persons with AIDS.59-62 However, varicella
vaccination (with a 2-dose schedule of VV) of asymptomatic HIV-infected
persons >12 months of age with an age-specific CD4+ count of 15%
may be considered63-65 (see HIV-infected persons in 3.3.3 Vaccination of
immunocompromised persons). Since studies have not been performed using
combination MMRV vaccines in asymptomatic HIV-infected persons
or persons with an age-specific CD4+ count of 15%, it is recommended
that only MMR vaccine and monovalent VV be considered for use in this
setting.60,64,65
immunocompromise (see 3.3.3 Vaccination of immunocompromised persons).
Persons receiving high-dose systemic immunosuppressive therapy, such
as chemotherapy, radiation therapy or oral corticosteroids. Varicellacontaining vaccines are contraindicated in persons taking high-dose oral
attenuated vaccines after corticosteroid therapy has been discontinued for at
least 1 month66 (see 3.3.3 Vaccination of immunocompromised persons).
4.22 VARICELLA
received varicella vaccine while breastfeeding showed no evidence of VZV DNA

in breast milk samples, and no effects on breastfed infants have been reported.58
Post-partum vaccination of women without evidence of varicella immunity need
not be delayed because of breastfeeding.
See also 3.3 Groups with special vaccination requirements and 4.9 Measles for more
information.
Pregnant women
See also 4.22.8 Pregnancy and breastfeeding above.
Varicella-containing vaccines are contraindicated in pregnant women.
This is due to the theoretical risk of transmission of the varicella component
of the vaccine to a susceptible fetus. However, no evidence of vaccine-induced
congenital varicella syndrome has been reported. Data from a registry,
established in the United States to monitor the maternalfetal outcomes of
pregnant women who were inadvertently administered VV either 3 months
before, or at any time during, pregnancy, showed that, among the 587
prospectively enrolled women (including 131 live births to women known to be
varicella-zoster virus-seronegative), there was no evidence of congenital varicella
syndrome.67 The rate of occurrence of congenital anomalies from prospective
reports in the registry was similar to reported rates in the general United States
population (3.2%) and the anomalies showed no specific pattern or target organ.
A non-immune pregnant household contact is not a contraindication to
vaccination with varicella-containing vaccines of a healthy child or adult in the
same household. The benefit of reducing the exposure to varicella by vaccinating
healthy contacts of non-immune pregnant women outweighs any theoretical
risks of transmission of vaccine virus to these women.
4.22.10 Precautions
For additional precautions related to MMRV vaccines, see 4.9 Measles.

If a varicella-containing vaccine is not given simultaneously with other live
attenuated parenteral vaccines (e.g. MMR, BCG, yellow fever), the vaccines
should be given at least 4 weeks apart.

Administration of MMR or MMRV vaccine should be delayed after
to measles, mumps, rubella and varicella vaccination may be impaired.68-70
VV or MMRV vaccine should not be given for between 3 and 11 months
following the administration of immunoglobulin-containing products. The
interval between receipt of the blood product and vaccination depends on the
amount of immunoglobulin in each product, and is indicated in 3.3 Groups with
special vaccination requirements, Table 3.3.6 Recommended intervals between either
immunoglobulins or blood products and MMR, MMRV or varicella vaccination.69
immunoglobulin and other blood products and 4.22.13 Variations from product
information below.
Varicella vaccine may be administered concomitantly with, or at any time in

immunoglobulin does not interfere with the antibody response to vaccine.

following vaccination with varicella-containing vaccines, unless the benefits
administered within this interval, the vaccinated person should be revaccinated
later at the appropriate time following the product (as indicated in Table 3.3.6
Recommended intervals between either immunoglobulins or blood products and MMR,
MMRV or varicella vaccination).
Rh (D) immunoglobulin (anti-D) may be given at the same time, in different sites
with separate syringes, or at any time in relation to varicella vaccine, as it does
not interfere with the antibody response to the vaccine.

Persons receiving long-term salicylate therapy (aspirin) should be vaccinated if
indicated, as the benefit is likely to outweigh any possible risk of Reye syndrome
occurring after vaccination. Natural varicella infection and salicylate use has
been associated with an increased risk of developing Reye syndrome. However,
there have been no reports of an association between Reye syndrome and
varicella vaccination (see 4.22.13 Variations from product information below).

If using MMRV vaccine, additional adverse events relating to the measles,
mumps and rubella vaccine components are discussed in 4.9 Measles, 4.11 Mumps
and 4.18 Rubella.
Adverse events following administration of varicella-containing vaccines are
generally mild and well tolerated.71
Injection site reactions (pain, redness or swelling) are the most common adverse
events reported after varicella vaccination, occurring in 7 to 30% of vaccine
recipients, but are generally well tolerated.2,71
A maculopapular or papulovesicular rash may develop after varicella
vaccination (usually within 5 to 26 days). A VV-associated rash is likely to
occur in less than 5% of vaccine recipients, and to last for less than 1 week.72,73
Rashes typically consist of 2 to 5 lesions and may be generalised (35%), or also
commonly occur at the injection site (35%).66 VV-associated rash may be atypical
and may not be vesicular. Most varicelliform rashes that occur within the first
4.22 VARICELLA
VV or MMRV vaccines.
2 weeks after vaccination are due to wild-type VZV, with median onset 8 days
after vaccination (range 1 to 24 days), while vaccine-strain VZV rashes occur at a
median of 21 days after vaccination (range 5 to 42 days).74,75
Transmission of vaccine virus to contacts of vaccinated persons is rare. In the
United States, where more than 56 million doses of VV were distributed between
1995 and 2005, there have been only six well-documented cases of transmission
of the vaccine-type virus from five healthy vaccine recipients who had a vaccineassociated rash.66,76 Contact cases have been mild.66,76-78
Fever >39C has been observed in 15% of healthy children after varicella
vaccination, but this was comparable to that seen in children receiving placebo.66
In adults and adolescents, fever has been reported in 10% of VV recipients. It is
recommended that parents/carers/vaccine recipients be advised about possible
symptoms, and given advice for reducing fever, including the use of paracetamol
for fever in the period 5 to 12 days after vaccination. Higher rates of fever were
observed in clinical trials of both MMRV vaccines, particularly following dose 1,
when compared with giving MMR vaccine and monovalent VV at the same
time but at separate sites.36-39 Two post-marketing studies in the United States
identified an approximately 2-fold increased risk of fever and febrile convulsions
in 1st dose recipients of MMRV vaccine, who were predominantly 1223 months
of age, in the period 7 to 10 days79 (or 5 to 12 days)80 after vaccination, compared
with recipients of separate MMR and VV vaccines. MMRV vaccination resulted
in 1 additional febrile seizure for every 2300 doses compared to separate MMR
and VV vaccination.79 An increase in fever or febrile convulsions has not been
identified after the 2nd dose of MMRV vaccine in the United States, although
most 2nd dose recipients were aged 46 years, an age at which the incidence of
febrile convulsions is low.81 These post-marketing studies were in children who
received ProQuad; however, it is anticipated that this side effect profile would be
similar in Priorix-tetra recipients.
A post-marketing study in the United States reported serious adverse events
temporally, but not necessarily causally, linked to varicella vaccination, such
as encephalitis, ataxia, thrombocytopenia and anaphylaxis, were very rare and
occurred in <0.01% of doses distributed.49,75 There were no neurological adverse
events following VV in which the Oka vaccine virus strain was detected in
cerebrospinal fluid (CSF).
Herpes zoster (HZ) has been reported rarely in vaccine recipients and has
been attributed to both the vaccine strain and to wild-type varicella virus
reactivation.74 Reactivation of the vaccine virus resulting in HZ is rare and most
cases of HZ in vaccine recipients can be attributed to reactivation of wild-type
virus following unrecognised prior infection. The risk of developing HZ is
currently thought to be lower after vaccination than after natural varicella virus
infection, and reported cases have been mild.2 Rates of herpes zoster in children
09 years of age after natural VZV infection were estimated to be between 30
and 74 per 100 000 per year,82,83 while a rate of 22 per 100 000 person-years was
reported in a 9-year follow-up of 7000 varicella vaccinated children.27 (See also

4.24 Zoster.)
Varicella is a notifiable disease in most states and territories in Australia.
Further instructions about the public health management of varicella, including
management of cases of varicella and their contacts, should be obtained from
state/territory public health authorities (see Appendix 1 Contact details for
Australian, state and territory government health authorities and communicable
disease control).
Zoster Immunoglobulin-VF (human) CSL Limited. 160mg/
mL immunoglobulin (mainly IgG) prepared from human plasma
containing high levels of antibody to the varicella-zoster virus. Single
vials contain 200IU of varicella-zoster antibody, with the actual
volume stated on the label on the vial. Also contains glycine.
High-titre zoster immunoglobulin (ZIG) is available from the Australian Red

Cross Blood Service on a restricted basis for the prevention of varicella in highrisk subjects who report a significant exposure to varicella or HZ. ZIG has no
proven use in the treatment of established varicella or zoster infection. ZIG is
highly efficacious, but is often in short supply. Normal human immunoglobulin
(NHIG) can be used for the prevention of varicella if ZIG is unavailable.
Post-exposure prophylaxis using varicella vaccine may also be indicated, if
vaccination is not contraindicated (see below).
Zoster immunoglobulin should only be given by IM injection.
Significant exposure to VZV is defined as living in the same household as a
person with active varicella or HZ, or direct face-to-face contact with a person
with varicella or HZ for at least 5 minutes, or being in the same room for at least
1 hour. In the case of varicella infection, the period of infectivity is from 48 hours
before the onset of rash until crusting of all lesions has occurred. Transmission
from a person with localised zoster is less likely than from a person with
varicella.4
Immunocompetent varicella contacts should be tested for varicella-zoster
antibodies.
ZIG must be given early in the incubation period (within 96 hours of exposure),
but may have some efficacy if administered out to as late as 10 days post
exposure. ZIG is able to prevent or ameliorate varicella in infants <1 month of
age, in children who are being treated with immunosuppressive therapy, and
in pregnant women. Persons with primary or acquired diseases associated with
cellular immune deficiency and those receiving immunosuppressive therapy
4.22 VARICELLA
4.22.12 Public health management of varicella
should be tested for varicella-zoster antibodies following contact with a person

with confirmed varicella. However, testing should not delay ZIG administration
after initial exposure to a case.84-86
ZIG administration (preferably within 96 hours and up to 10 days after exposure)
is required for the following groups and should not be delayed by testing (if
indicated below):
Pregnant women who are presumed to be susceptible to varicella infection.
If practicable, they should be tested for varicella-zoster antibodies before
ZIG is given.5
Neonates whose mothers develop varicella from 7 or fewer days before
delivery to 2 days after delivery. ZIG must be given, as the neonatal mortality
without ZIG is up to 30% in this setting.1,7 ZIG must be given as early as
possible in the incubation period.
Neonates exposed to varicella in the 1st month of life, if the mother has no
personal history of infection with VZV and is seronegative.27 ZIG should
be given, due to the increased risk of severe varicella in newborns of
seronegative women.
Premature infants (born at <28 weeks gestation or whose birth weight
is <1000g) exposed to VZV while still hospitalised should be given ZIG
regardless of maternal history of varicella.
Patients suffering from primary or acquired diseases associated with cellular
immune deficiency, and those receiving immunosuppressive therapy.85,86
Note: If an immunocompromised VZV contact is shown to have recent evidence
of detectable antibodies, it is not necessary to give ZIG, as its administration will
not significantly increase varicella-zoster antibody titres in those who are already
antibody positive. Note that varicella-zoster antibodies detected in patients who
have been transfused or who have received intravenous immunoglobulin or ZIG
in the previous 3 months may be passively acquired and transient.
The dose schedule recommended for ZIG administration is shown in Table 4.22.2.
Table 4.22.2: Zoster immunoglobulin-VF (ZIG) dose based on weight
Weight of patient (kg)
010
1130
>30
Dose (IU)
200
400
600
A dose of ZIG may be repeated if a 2nd exposure occurs more than 3 weeks
after the 1st dose of ZIG. However, testing for varicella antibodies is also
recommended (see above). NHIG can be used for the prevention of varicella if
ZIG is unavailable (see Part 5 Passive immunisation). Persons receiving monthly
high-dose intravenous NHIG are likely to be protected and probably do not

require ZIG if the last dose of NHIG was given 3 weeks or less before exposure.
If VV is not contraindicated, it can be offered to non-immune age-eligible
children and adults who have a significant exposure to varicella or HZ and
wish to be protected against primary infection with VZV (see Post-exposure
vaccination in 4.22.7 Recommendations above).51-55 Vaccination has the added
benefit of reducing the likelihood of varicella infection, particularly moderate
to severe disease, following exposure, and also provides long-term protection.
Vaccination of exposed persons during outbreaks has also been shown to prevent
further cases and to control outbreaks.55 If MMR vaccination is also indicated,
MMRV vaccine can be used in children <14 years of age, although MMRV
vaccine is not routinely recommended as the 1st dose of MMR-containing vaccine
in children aged <4 years (see 4.22.7 Recommendations above).
Post-exposure vaccination should be administered within 5 days, and preferably
within 3 days, after exposure.51-55

Varilrix and Varivax Refrigerated are registered for use as 2 doses of 0.5mL
(12 months apart) in adolescents 13 years of age and adults. The ATAGI instead
recommends a single dose of varicella vaccine for children <14 years of age and
2 doses of varicella vaccine in those aged 14 years.
In adults and adolescents where 2 doses of varicella vaccine are required, the
product information for Varilrix states that the 2nd dose should be given at least
6 weeks after the 1st dose. The ATAGI recommends instead that the 2nd dose
may be given at least 4 weeks after the 1st dose.
The product information for both monovalent varicella vaccines and both MMRV
vaccines recommends that women of child-bearing age should be advised not to
become pregnant for 3 months after vaccination. The ATAGI instead recommends
avoiding pregnancy for 28 days after vaccination.87
The product information for Priorix-tetra and ProQuad states that persons
with a history of anaphylactic or anaphylactoid reactions to egg should not be
vaccinated. The ATAGI recommends instead that either Priorix-tetra or ProQuad
can be given in this situation.68
The product information for Priorix-tetra states that it should be given by SC
injection. The ATAGI recommends that it may also be given by IM injection.
The product information for ProQuad states that this vaccine is indicated for
vaccination in individuals 12 months through 12 years of age. The product
information for Priorix-tetra states that this vaccine can be used in persons from
9 months of age. The ATAGI recommends instead that both MMRV vaccines
can be given to persons up to 14 years of age. The ATAGI also recommends that
4.22 VARICELLA
Vaccination for post-exposure prophylaxis
MMRV vaccine should not be used routinely as the 1st dose of MMR-containing
vaccine in children aged <4 years.
The product information for all varicella-containing vaccines states that
salicylates should be avoided for 6 weeks after vaccination, as Reye syndrome
has been reported following the use of salicylates during natural varicella
infection. The ATAGI recommends instead that non-immune persons receiving
long-term salicylate therapy can receive varicella-containing vaccine, as the
benefit is likely to outweigh any possible risk of Reye syndrome occurring after
vaccination.
The product information for Varivax Refrigerated recommends delaying
vaccination for 5 months after receipt of NHIG by IM injection or blood
transfusion. The ATAGI recommends instead that varicella-containing vaccines
should not be given for at least 3 months after receipt of immunoglobulincontaining blood products according to the intervals contained in Table 3.3.6
Recommended intervals between either immunoglobulins or blood products and MMR,
MMRV or varicella vaccination.
The dosage of ZIG recommended in the product information differs from that in
Table 4.22.2, which has been revised in order to minimise wastage of ZIG.
References
4.23 YELLOW FEVER

Yellow fever is a viral haemorrhagic fever caused by an RNA flavivirus that
is transmitted by mosquitoes. Aedes aegypti, a highly domesticated mosquito
found throughout the tropics, is the vector responsible for person-to-person
transmission of the yellow fever virus in urban and inhabited rural areas in
endemic countries.

The clinical spectrum of yellow fever varies from a non-specific febrile illness to
fatal haemorrhagic fever.1 After an incubation period of 3 to 6 days, the disease
begins abruptly with fever, prostration, myalgia and headache. The patient
appears acutely ill with congestion of the conjunctivae; there is an intense
viraemia during this period of infection, which lasts 3 to 4 days.1 This may be
followed by the period of remission, in which the fever and symptoms settle
over 24 to 48 hours, during which the virus is cleared by immune responses.1
Approximately 15 to 25% of patients may then relapse with a high fever,
vomiting, epigastric pain, jaundice, renal failure and haemorrhage: the period
of intoxication.1 These complications can be severe, and reflect the viscerotropic
nature of the yellow fever virus (its ability to infect the liver, heart and
kidneys). The case-fatality rate varies widely, but can be more than 20% in local
populations.2
4.23.3 Epidemiology
Yellow fever occurs in tropical regions of Africa and Central and South America.
In both regions the virus is enzootic in rainforest monkeys and canopy mosquito
species; sporadic human cases occur when people venture into these forests
(sylvatic or jungle yellow fever).1
In moist savannah regions in Africa, especially those adjacent to rainforests, tree
hole-breeding Aedes mosquito species are able to transfer yellow fever virus from
monkeys to people and then between people, leading to small-scale outbreaks
(intermediate yellow fever).
Ae.aegypti occurs in both heavily urbanised areas and settled rural areas in
tropical Africa and the Americas.1 Epidemics of urban yellow fever occur when
a viraemic individual (with yellow fever) infects local populations of Ae.aegypti;
such epidemics can be large and very difficult to control. Although Ae.aegypti
also occurs throughout much of tropical Asia and Oceania (including north
Queensland), yellow fever has never been reported from these regions.
Although yellow fever is undoubtedly markedly under-reported, it is clear that
there has been a considerable increase in the reported number of outbreaks, and
therefore cases, of yellow fever in past decades.3 Most of this increase was in
4.23 YELLOW FEVER
4.23.1 Virology
Africa, particularly in West African countries.3,4 In 2008, there were 24 cases of

yellow fever reported near Asuncin in Paraguay with 8 deaths.5
The risk of susceptible travellers acquiring yellow fever varies considerably
with season, location, duration of travel and utilisation of mosquito avoidance
measures. There have been reported cases of yellow fever, all fatal, in
unvaccinated travellers to Africa and South America.6
4.23.4 Vaccine
Stamaril Sanofi Pasteur Pty Ltd (live attenuated yellow fever virus
[17D strain]). Lyophilised powder in a monodose vial with a pre-filled
diluent syringe. Each 0.5mL reconstituted dose contains 1000 mouse
LD50 units; 16.0mg lactose; 8.0mg sorbitol; 0.833 mg L-histidine
hydrochloride. May contain traces of egg proteins.
Yellow fever vaccine is a live, freeze-dried preparation of attenuated 17D strain

yellow fever virus cultured in, and harvested from, embryonated chicken eggs.
The vaccine does not contain antibiotics, preservatives or gelatin.
Vaccination elicits protective levels of neutralising antibodies in approximately
90% of adult vaccine recipients by day 14, and in virtually all by day 28.7
Immunity is long-lasting and perhaps life-long; regardless, revaccination is
required after 10 years under International Health Regulations for a valid
International Certificate of Vaccination or Prophylaxis (ICVP) against yellow
fever. Because the vaccine produces a transient very low level viraemia in healthy
adult recipients, they cannot serve as a source of infection for mosquitoes.7
Although the efficacy of the yellow fever vaccine has never been determined in
prospective clinical trials, there is considerable observational evidence that it is
very effective in preventing the disease.7

Stamaril must be reconstituted by adding the entire contents of the diluent syringe
vaccine must be used within 1 hour.

The dose of yellow fever vaccine for children and adults is 0.5mL, to be given by
either IM or SC injection.
Test doses of yellow fever vaccine should never be used (see 4.23.13 Variations
from product information below).
Inactivated vaccines and oral live vaccines relevant to travel (e.g. cholera,
typhoid) can be given with, or at any time before or after, yellow fever vaccine.
Yellow fever vaccine can be given at the same time as the Imojev Japanese
encephalitis vaccine,9 using separate syringes and separate injection sites.
Children aged <9 months
Yellow fever vaccine is contraindicated in infants aged <9 months.
Children aged 9 months and adults

A single dose of yellow fever vaccine is recommended for:
persons 9 months of age travelling to, or living in, areas with a risk of yellow
fever virus transmission. Information risk for specific destinations should
be sought from a reputable source, such as the World Health Organization
(WHO),10 prior to travel.
laboratory personnel who routinely work with yellow fever virus.
Those persons who are at ongoing risk of yellow fever virus exposure and who
received a yellow fever vaccine more than 10 years ago will require a booster.
Vaccination is generally not recommended when travelling to areas where there
is low potential for yellow fever virus exposure (i.e. no human yellow fever
cases ever reported and evidence to suggest only low levels of yellow fever
virus transmission in the past). However, vaccination might be considered for a
small subset of travellers to these areas who are at increased risk of exposure to
mosquitoes or unable to avoid mosquito bites.
International travel requirements

All those travelling to, or living in, countries with a risk of yellow fever virus
transmission should be informed that the mosquito vectors of yellow fever
usually bite during the day. They should be advised of the necessity for
mosquito avoidance measures, even if vaccinated. These include the use of insect
repellents, coils and sprays, the use of mosquito nets (preferably those that have
been treated with an insecticide), and adequate screening of residential (and
work) premises.
Many countries require that travellers arriving from countries with a risk of
yellow fever virus transmission provide evidence of yellow fever vaccination
prior to entry. This is because importation of the virus into these countries by an
infected traveller could result in introduction and establishment of the virus in
local Ae.aegypti mosquitoes. Under International Health Regulations, countries
4.23 YELLOW FEVER
If administration of both yellow fever and other parenteral live viral vaccines is
indicated, the vaccines should be given either on the same day or at least 4 weeks
apart (see 4.23.10 Precautions below).
are free to set their own requirements for entry and some countries require a
valid International Certificate of Vaccination or Prophylaxis against yellow
fever or a valid letter of exemption for all arriving travellers. A country may
require such documentation even for travellers who are only in transit through
that country. The most recent WHO list of individual country yellow fever
vaccination requirements and recommendations for travellers can be found at
www.who.int/ith/chapters/ith2012en_countrylist.pdf. As yellow fever disease
patterns, like other diseases, are constantly changing, it is recommended that
the entry requirements for yellow fever vaccination for the countries a traveller
intends to enter or transit through be confirmed by contacting the countrys
foreign missions in Australia.
Travellers >1 year of age entering or returning to Australia within 6 days of
leaving a country on Australias list of yellow fever declared places are required
to have a valid International Certificate of Vaccination or Prophylaxis with
proof of valid yellow fever vaccination (see below). This list is developed
based on the WHO list of countries with risk of yellow fever virus transmission
and international surveillance data, and is available from the Australian
Government Department of Healths yellow fever fact sheet (www.health.gov.
au/yellowfever). Travellers who do not have a valid certificate are provided with
information on yellow fever and required to promptly seek medical assessment if
they develop relevant symptoms within 6 days of leaving the declared place.
Yellow fever vaccine can be administered only by Yellow Fever Vaccination
Centres approved by the relevant state or territory health authorities. Each
yellow fever vaccination is to be recorded in an International Certificate of
Vaccination or Prophylaxis, with proof of valid yellow fever vaccine; the
certificate must include the vaccinated persons name and signature (or the
signature of a parent or guardian of a child), and the signature of a person
approved by the relevant health authority. The date of the vaccination must be
recorded in daymonthyear sequence, with the month written in letters, and the
official stamp provided by the state or territory health authority must be used.
The certificate becomes valid 10 days after vaccination, and remains valid for
10 years.
Note: People with a true contraindication to yellow fever vaccine (see 4.23.9
Contraindications below) who intend to travel to yellow fever risk countries
should obtain a letter from a doctor, clearly stating the reason for withholding
the vaccine. The letter should be formal, signed and dated, and on the practices
letterhead. Arriving travellers who possess an exemption from the yellow fever
vaccination are provided with information on yellow fever and required to
promptly seek medical assessment if they develop relevant symptoms.
As with all live attenuated virus vaccines, unless there is a risk of exposure to the
virus, yellow fever vaccine should not routinely be given to pregnant women.
Pregnant women should be advised against going to the rural areas of yellow
fever endemic areas (and to urban areas of West African countries as well).
However, where travel to an at-risk country is unavoidable, such women should
be vaccinated (see 4.23.7 Recommendations above).11-14
The yellow fever vaccine has been given to considerable numbers of pregnant
women7,11,12 with no evidence of any adverse outcomes. Therefore, women
vaccinated in early pregnancy can be reassured that there is no evidence of risk to
themselves and very low (if any) risk to the fetus.7
Administration of yellow fever vaccine to women who are breastfeeding infants
aged <9 months (and therefore unable to be vaccinated) should be avoided,
except in situations where exposure to yellow fever virus cannot be avoided
or postponed.13,14 While extremely rare, there have been several case reports of
transmission of the vaccine strain of yellow fever virus via breast milk.13,14
Yellow fever vaccine is contraindicated in persons who have had:
anaphylaxis following a previous dose of the vaccine
In particular, the vaccine is contraindicated in persons with a known anaphylaxis
to eggs. Persons with a known allergy to eggs wishing to receive yellow fever
vaccination should discuss this with either an immunologist/allergist or be
referred to a specialised immunisation adverse events clinic. Contact a specialist
travel medicine clinic or your local state or territory health authority for further
details (see Appendix 1 Contact details for Australian, state and territory government
health authorities and communicable disease control).
Infants
Routine yellow fever vaccine is contraindicated in infants <9 months of age.
Countries experiencing a mass outbreak of yellow fever may elect to immunise
infants from as young as 6 months of age.
4.23 YELLOW FEVER
Yellow fever vaccine is not recommended for pregnant women or women

breastfeeding infants aged <9 months.
Altered immune status

As with all live viral vaccines, the yellow fever vaccine should generally not
be given to people who are immunocompromised due to either disease or
medical treatment (see 3.3.3 Vaccination of immunocompromised persons). However,
studies of small numbers of HIV-infected participants, mainly travellers with
CD4+ counts >200 per L, have shown reduced immune response, but good
tolerability.15
Thymus disorders
People with a history of any thymus disorder, including myasthenia gravis,
thymoma, thymectomy and DiGeorge syndrome, or thymic damage from
chemoradiotherapy or graft-versus-host disease, should not be given the yellow
fever vaccine due to the increased risk of yellow fever vaccine-associated
viscerotropic disease (see 4.23.11 Adverse events below).
4.23.10 Precautions
The risk of severe adverse events following yellow fever vaccine is considerably
greater in those aged 60 years than in younger adults.16-19
Adults 60 years of age should be given yellow fever vaccine only if they intend
to travel to endemic countries (as recommended above) and they have been
informed about the (albeit very low) risks of developing a severe complication.

The administration of other parenteral live viral vaccines (e.g. MMR, MMRV,
varicella or zoster vaccine) should be on the same day as yellow fever vaccine, or
separated by a 4-week interval.

Mild adverse events
Adverse events following yellow fever vaccine are generally mild. Vaccine
recipients often report mild headaches, myalgia and low-grade fevers or other
minor symptoms for 5 to 10 days post vaccination. In clinical trials in which
symptoms are actively elicited, up to 25% of vaccine recipients report mild
adverse events and up to 1% curtail regular activities.7,19,20
Immediate hypersensitivity reactions

Immediate hypersensitivity reactions, including anaphylaxis, following yellow
fever vaccine are very rare, with an incidence of less than 1 in 1 million, and
occur principally in people with anaphylactic sensitivity to eggs.7,18,19 Although
it has been suggested that an anaphylactic sensitivity to gelatin (added as a
stabiliser to some yellow fever vaccines) may also precipitate anaphylaxis
following vaccination,21 Stamaril does not contain gelatin.
Vaccine-associated neurotropic adverse events
Vaccine-associated viscerotropic adverse events

Recently, an apparently very rare (and often fatal) complication, yellow fever
vaccine-associated viscerotropic disease (YF-AVD), characterised by multiorgan system failure, has been recognised following yellow fever vaccination. It
appears that overwhelming infection with the 17D vaccine virus is responsible
for these viscerotropic adverse events.7,18
Vaccine-associated viscerotropic adverse events do not appear to be caused by
altered virulence of the vaccine virus, but rather appear to be related to host
factors. Although cases have occurred in younger persons, it is apparent that the
risk is increased with advanced age, particularly in those aged 60 years.16,17,19
Another host factor associated with an increased risk of a viscerotropic adverse
event is pre-existing thymus disease. Published reports of YF-AVD cases have
indicated that 4 of the 27 reported cases had a history of thymic tumour and
thymectomy, both uncommon conditions.18,22
4.23.12 Public health management of yellow fever

Yellow fever is a notifiable and quarantinable disease in all states and territories
in Australia.
Further instructions about the public health management of yellow fever,
including management of cases of yellow fever and their contacts, should

The product information states that pregnancy is a contraindication to the yellow
fever vaccine. The ATAGI recommends instead that pregnant women who insist
on travelling to endemic countries should be vaccinated.
The product information suggests that a 0.1 mL test dose of yellow fever vaccine
can be used intradermally to assess an individual with suspected allergy to the
vaccine. The ATAGI instead recommends that (with the exception of Q fever
vaccine) test doses should never be used.
References
4.23 YELLOW FEVER
Yellow fever vaccine-associated neurotropic disease (YF-AND) is rare.18

At least 25 cases of meningoencephalitis following yellow fever
vaccination have been reported.7 However, 15 of these cases occurred in
the 1950s in infants 7 months of age. Following recommendations in
the early 1960s not to vaccinate young infants, the incidence of vaccineassociated meningoencephalitis declined considerably.7 Nevertheless,
these adverse events, albeit very rare, still occur in adults; the risk is
greater in persons 60 years of age.16,17
4.24 ZOSTER (herpes zoster)

4.24.1 Virology
Varicella-zoster virus (VZV) is a DNA virus that is a member of the herpesvirus
family. Primary infection with VZV is known as varicella or chickenpox.1
Herpes zoster (HZ), or shingles, is caused by reactivation of latent VZV, which
typically resides in the dorsal root or trigeminal nerve ganglia following primary
infection.1

Reactivation of VZV causing HZ is thought to be particularly due to a decline in
cellular immunity to the virus, and presents clinically as a unilateral vesicular
rash in a dermatomal distribution in the majority of cases. A prodromal phase
occurs 48 to 72 hours prior to the appearance of the lesions in 80% of cases.2
Associated symptoms may include headache, photophobia, malaise, and an
itching, tingling or severe pain in the affected dermatome.3,4 In the majority of
patients, HZ is an acute and self-limiting disease, with the rash lasting 10 to
15 days.1,3 However, complications can occur, especially with increasing age.
Post-herpetic neuralgia (PHN), the most frequent debilitating complication
of HZ, is a neuropathic pain syndrome that persists or develops after
the dermatomal rash has healed. By definition, PHN is established when
pain persists for longer than 3 months after the onset of the rash.5,6 Other
complications may occur, depending on the site of reactivation. These include
ophthalmic disease (such as keratitis and chorioretinitis), neurological
complications (such as meningoencephalitis and myelitis), secondary bacterial
skin infection, scarring and pneumonia.7 Rarely, disseminated HZ may develop,
with widespread vesicular rash, and visceral, central nervous system and
pulmonary involvement. Disseminated disease is more common in persons who
are immunocompromised.4 Dermatomal pain without the appearance of rash is
also documented (zoster sin herpte).
Antiviral therapy, if initiated within 3 days of the onset of HZ, has been shown
to reduce the severity and duration of HZ and may reduce the risk of developing
PHN.8-12 However, despite medical therapy, PHN may persist for years and can
be refractory to treatment.13
4.24.3 Epidemiology
HZ occurs most commonly with increasing age (>50 years), immunocompromise,
and following a history of varicella in the 1st year of life. The lifetime risk of
reactivation of VZV causing HZ is estimated to be approximately 20 to 30%
and it affects half of those who live to 85 years.1,14-16 Second attacks of HZ occur
in approximately 5% of immunocompetent persons, but are more frequent
in persons who are immunocompromised.3,17,18 Using Australian general
practice and other data, approximately 490 cases per 100 000 (range 330830
per 100 000) are estimated to occur annually in all ages, with approximately
Overall, an estimated 13 to 26% of patients with HZ develop complications.

Complications occur more frequently with increasing age, and with
immunocompromise.26,27 PHN occurs infrequently in young people, but, in
patients over the age of 50 years, it complicates HZ in 25 to 50% of cases.26,27
Modelling studies of the impact of universal childhood vaccination programs
for varicella have predicted that a rise in the incidence of HZ could occur, based
on the assumption that exposure to wild-type VZV circulating in the community
boosts immunity.28 However, to date, multiple studies and surveillance data do
not demonstrate any consistent changes in overall HZ incidence in the United
States, which has a universal varicella vaccination program that commenced
in 1995.29-31 Australian data show an increase in HZ GP consultation rates
over time, commencing prior to varicella vaccine introduction, which is
likely to be due to the increasing age of the population. Age-standardised HZ
hospitalisation rates have not declined since introduction of varicella vaccine,
and the use of zoster vaccine has not yet been extensive enough in any country
to expect an impact on HZ epidemiology.32-34 In the United States, the incidence
of HZ in children <10 years of age has declined, indicating that HZ rates are
lower in varicella vaccine recipients.30
4.24.4 Vaccine
Zostavax is a live attenuated vaccine formulated from the same VZV vaccine
strain (Oka/Merck) as the registered varicella (chickenpox) vaccine Varivax,
but is of higher potency (on average, at least 14 times greater). The higher
viral titre in Zostavax is required to elicit a boost in immune response in
adults who usually remain seropositive to VZV following primary infection,
but have declining cellular immunity with increasing age.35 Zostavax is used
for the prevention of HZ in persons >50 years of age. It is important to note
that the registered varicella vaccines are not indicated for use in preventing
HZ in older people and Zostavax is not indicated for use in younger people
who have not been previously immunised or infected with VZV. Zostavax is
not indicated for use for therapeutic benefit during an acute HZ episode, nor
for the treatment of PHN.
A single large, randomised, double-blind, placebo-controlled efficacy study of
the frozen formulation of Zostavax (known as the Shingles Prevention Study
1000 cases per 100 000 population in persons aged 50 years.19-22 In the large
efficacy study of zoster vaccine in the United States, the incidence of HZ in
unimmunised participants 60 years of age was 1112 cases per 100 000 personyears.23 The incidence in persons aged 5059 years is lower, with one study
estimating a rate of 470 per 100 000 person-years.24 The risk of HZ increases
with immunocompromise; for example, rates of HZ are up to 15 times higher in
those who are immunocompromised due to HIV infection, and, in the 1st year
following haematopoietic stem cell transplantation (HSCT), up to 30% of patients
may develop HZ.3,25
[SPS]) was conducted among 38 546 adults aged 60 years and demonstrated
that Zostavax significantly reduced the likelihood of developing both HZ and
PHN.23 Vaccination reduced the incidence of HZ by 51.3%, the incidence of PHN
by 66.5%, and the burden of illness associated with HZ by 61.1% over a median
of more than 3 years follow-up.23 The vaccine was more efficacious in reducing
HZ in persons aged 6069 years than in those aged 7079 years (64% compared
with 41% efficacy). However, efficacy against PHN was similar in both age
groups.23 Efficacy against HZ in the 80 years age group was lower (18% and not
statistically different to placebo). However, there were fewer participants of this
age in the SPS.36 In those who developed HZ despite vaccination, the severity
of pain associated with the episode was also reduced.37 Another randomised
controlled study in >22 000 5059-year olds demonstrated a reduction in the
incidence of HZ after a follow-up period of 1 year or more, with a vaccine
efficacy for preventing HZ of 69.8%.38 In these clinical trials many participants
were treated with antiviral and pain medication for their HZ, suggesting that
the effect of the vaccine was in addition to any benefit obtained from medical
therapy.23,38 Efficacy of a single dose of zoster vaccine appears to decline over
time, with recent data suggesting persistent efficacy through to the 5th year post
vaccination, with uncertain efficacy beyond that point.39 The need for a booster
dose has not yet been determined.
The Shingles Prevention Study, together with other smaller studies,
demonstrated that Zostavax is safe and generally well tolerated among adults
50 years of age.23,38 In the SPS, the most common adverse events were injection
site reactions, with Zostavax more likely to result in erythema, pain and swelling
at the injection site than placebo (48% versus 17%, respectively). Varicellalike rashes at the injection site were also more common in vaccine recipients;
however, varicella-like rash not localised to the injection site did not occur more
often. Varicella- or zoster-like rashes that were PCR-positive for VZV were
mostly due to wild-type VZV.23 Fever was no more common in vaccine recipients;
however, the rate of vaccine-related systemic symptoms was higher (Zostavax
6.3% versus placebo 4.9%), with the most frequently reported systemic symptoms
being headache and fatigue.23 Mild to moderate adverse events, particularly
injection site reactions, were higher in vaccine recipients aged 5059 years than in
those aged 60 years.38,40
In Australia, a refrigerated form of Zostavax is registered on the basis of
comparable immunogenicity and safety to the frozen vaccine formulation that
was used in the SPS.41 Zostavax was registered for use in persons 5059 years
of age based on a study that demonstrated similar immunogenicity in this age
group compared with those 60 years of age,40 and has since been shown to
reduce the incidence of HZ in this population.38 A study of the simultaneous
administration of Zostavax with inactivated influenza vaccine (given separately
and at different injection sites) demonstrated comparable immunogenicity and
safety to giving the vaccines at different times.42 A study of the simultaneous
Zostavax availability in Australia has been limited due to manufacturer supply

constraints.
Zostavax CSL Limited/Merck & Co Inc (live attenuated Oka/Merck
strain of varicella-zoster virus). Lyophilised powder in a monodose
vial with separate diluent. Each 0.65 mL reconstituted dose contains
19 400 plaque-forming units of attenuated varicella-zoster virus;
sucrose; gelatin; urea; monosodium glutamate; residual components
of MRC-5 cells; traces of neomycin and bovine serum albumin.

Zostavax is less stable than other commonly used live viral vaccines, and
adherence to storage and reconstitution requirements is very important.
Zostavax must be reconstituted by adding the entire contents of the diluent
Reconstitute immediately upon removal from the refrigerator. Reconstituted
vaccine must be used within 30 minutes.

The dose of Zostavax is 0.65mL, to be given by SC injection.
Zostavax must never be given where varicella (chickenpox) vaccine is indicated.
Zoster vaccine is only registered for use in adults 50 years of age.

Zostavax can be given at the same time as influenza vaccine,42 using separate
syringes and injection sites.
Simultaneous administration of Zostavax with pneumococcal polysaccharide
vaccine is not routinely recommended; if possible the two vaccines should be
given at least 4 weeks apart. However, inadvertent administration of Zostavax
and pneumococcal polysaccharide vaccine at the same time or at an interval of
less than 4 weeks does not require revaccination (see 4.24.4 Vaccine above).
administration of Zostavax with 23-valent pneumococcal polysaccharide vaccine

(Pneumovax 23; 23vPPV) suggested that the immunogenicity of Zostavax was
reduced when administered simultaneously with Pneumovax 23, compared with
administration 4 weeks apart.43 The immunogenicity of Pneumovax 23 was not
affected. However, an observational study from the United States suggests this
may not impact on Zostavax effectiveness.44-46
Zostavax can be administered at the same visit as, or at any time following
receipt of, other inactivated vaccines (e.g. tetanus-containing vaccines), if
required.
If administration of both Zostavax and another live parenteral vaccine (e.g. MMR
or yellow fever) is indicated, the vaccines should be given either on the same day
or at least 4 weeks apart. (See also 4.22 Varicella.)
A single dose of zoster vaccine is recommended for adults 60 years of age who
have not previously received a dose of zoster vaccine. Routine serological testing
prior to receipt of zoster vaccine is not indicated and it is not necessary to elicit
a history of previous varicella (chickenpox) infection (see Serological testing
before and after zoster vaccination below).
Persons with chronic medical conditions, such as arthritis, chronic renal
failure, diabetes and other conditions, can be given zoster vaccine, unless a
contraindication or precaution exists due to their condition or medical treatment
(see 4.24.9 Contraindications and 4.24.10 Precautions below). Persons with
significant immunocompromise should not receive zoster vaccine (see also 3.3.3
Vaccination of immunocompromised persons).
The zoster vaccine has been shown to be less efficacious in persons aged 80
years and may be less likely to provide a clinical benefit in this age group (see
4.24.4 Vaccine above).

Routine population-based use of zoster vaccine in persons aged 5059 years is
not recommended. Although the incidence of HZ in persons 5059 years of age
is higher than in younger age groups,19,22 and zoster vaccine is efficacious in
5059-year olds,38 the likelihood of developing PHN and other complications
of HZ is lower in this age group than in those 60 years of age.24,48 Persons aged
5059 years who wish to protect themselves against HZ can be vaccinated;
however, the duration of efficacy, and need for a booster dose at a later age, is
not yet determined (see 4.24.4 Vaccine above).
Persons aged <50 years

Zoster vaccination is not recommended for use in persons <50 years of age and
is not registered for use in this age group. There have been very limited studies
of the safety and immunogenicity of zoster vaccine in this age group (see 4.24.4
Vaccine above).
Persons with a history of a previous episode of HZ

Persons with a history of a previous episode of HZ can be given zoster vaccine.
It is possible that a history of previous zoster may be inaccurate or a mistaken
Persons previously vaccinated with varicella vaccine

Zoster vaccination of persons who have previously received varicella vaccine is
not recommended at this time. There have been limited studies of the safety and
immunogenicity of zoster vaccine in this setting, and the currently available data
are insufficient to suggest a benefit from vaccination. It is not yet known whether,
in the future, populations vaccinated with varicella vaccine will experience rates
of HZ sufficient to warrant zoster vaccination. Preliminary information suggests
that the incidence of HZ in persons who have received varicella vaccine is lower
than in those infected with wild-type varicella.30
Persons with immunocompromise due to HIV/AIDS

Studies of the use of zoster vaccine in HIV-infected persons have not been
completed. However, persons with asymptomatic HIV infection may be
considered for vaccination on a case-by-case basis after seeking appropriate
specialist advice. Serological confirmation of previous VZV infection must be
obtained prior to vaccination (see Serological testing before and after zoster
vaccination below). Although asymptomatic HIV-infected persons are likely
to have a higher relative risk of developing HZ in the future,25 it is possible that
both the efficacy and the safety of zoster vaccination may be reduced in such
recipients, as compared with uninfected persons.
Vaccination with zoster vaccine is not recommended for persons with AIDS or
symptomatic HIV infection (see 3.3 Groups with special vaccination requirements,
Table 3.3.4 Categories of immunocompromise in HIV-infected persons, based on
age-specific CD4+ counts and percentage of total lymphocytes), or significant
immunocompromise due to other diseases and/or treatment (see 4.24.9
Contraindications below).
Persons anticipating future significant immunocompromise

Immunocompetent persons who anticipate alteration of their immunity because
of their existing illness can be given zoster vaccine on a case-by-case basis
after seeking appropriate specialist advice.36 Persons with conditions such as
chronic lymphocytic leukaemia, conditions requiring organ transplantation,50
diagnosis. In addition, the risk of a repeat episode of zoster has been estimated
at approximately 5% in immunocompetent persons.17,18,48 Persons with a history
of HZ were excluded from the SPS, so no data on the efficacy of the vaccine in
those with a history of HZ is available. The safety and immunogenicity of zoster
vaccine in persons with a history of HZ has been studied in one small clinical
trial; the vaccine was well tolerated and immunogenic.49 Injection site reactions
were more common in vaccine recipients than in placebo recipients, but similar
to vaccine recipients in the SPS. Systemic adverse events were similar between
groups.23 The length of time following an episode of HZ after which it would be
reasonable to vaccinate has not been established. However, it is suggested that
the vaccine could be given at least 1 year after the episode of HZ.
solid tumours that will require future chemotherapy or radiation therapy, and
inflammatory diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus,
inflammatory bowel disease, psoriasis) may have minimal alteration to their
immune system, but can anticipate significant immunocompromise in the future
due to their disease and/or treatment. Since these persons are at higher risk of
developing zoster than if they remained immunocompetent, vaccination at least
1 month prior to the onset of immunocompromise may be appropriate (after
seeking specialist advice).36 Serological confirmation of previous VZV infection
must be obtained prior to vaccination (see Serological testing before and after
zoster vaccination below).

Vaccination is recommended for persons 50 years of age who are household
contacts of a person who is immunocompromised. Based on evidence that the
rate of VZV-like rashes after vaccination is extremely low, it is unlikely that
transmission of vaccine-associated virus to a susceptible contact would occur.23
If a vaccinated person develops a varicella- or zoster-like rash, they should cover
the rash and avoid contact with persons who are immunocompromised for the
duration of the rash. The efficacy of the HZ vaccine is less than 100%, and rashes
in vaccinated persons may be due to reactivation of wild-type VZV. If household
contacts (<50 years of age) of a person who is immunocompromised have not
been previously infected with VZV or immunised with varicella vaccine, they
should receive varicella vaccine (see 4.22 Varicella).
Serological testing before and after zoster vaccination

Neither history of previous varicella infection nor evidence of prior immunity
to VZV is required prior to the routine administration of the zoster vaccine
(with the exception of immunocompromised persons, see below). Most older
people in Australia are seropositive to VZV due to previous primary varicella
infection. Limited data from small studies of the administration of high-dose
VZV-containing vaccine (comparable to Zostavax) to VZV seronegative adults,
compared with previously infected adults, suggest that the vaccine was well
tolerated and immunogenic in seronegative persons, although the incidence of
self-limited injection site reactions may be slightly higher.51,52 If an adult eligible
for zoster vaccine has laboratory evidence of a lack of immunity to VZV, and
does not have a history of age-appropriate varicella vaccination, they should be
vaccinated with 2 doses of varicella vaccine, rather than zoster vaccine (see 4.22
Varicella).
Serological testing prior to zoster vaccination is recommended if vaccination
is being considered for persons with asymptomatic HIV infection or
persons anticipating significant immunocompromise (see Persons with
immunocompromise due to HIV/AIDS and Persons anticipating future
significant immunocompromise above).

VZV-containing vaccines are contraindicated in pregnant women, although
women of child-bearing age are not eligible for zoster vaccination. Pregnancy
should be avoided for 28 days after vaccination (see 4.22 Varicella).
A non-immune pregnant household contact is not a contraindication to zoster
vaccination.
Zoster vaccine is contraindicated in persons who have had:
anaphylaxis following a previous dose of any VZV-containing vaccine

Live attenuated zoster vaccine is contraindicated in persons with significant
immunocompromise due to either a primary or acquired medical condition, or
due to medical treatment. This includes persons receiving high-dose systemic
immunosuppressive therapy, such as chemotherapy, radiation therapy or
oral corticosteroids; persons suffering from malignant conditions of the
reticuloendothelial system (such as lymphoma, leukaemia, Hodgkins disease);
and any person with similar immunocompromise due to a disease or treatment
(see 3.3.3 Vaccination of immunocompromised persons).
Persons who have been receiving high-dose systemic steroids (or equivalent)
and have ceased therapy may be vaccinated (see 3.3.3 Vaccination of
immunocompromised persons). Persons on low-dose corticosteroids or less
significantly immunocompromised than described above, may be considered for
vaccination on a case-by-case basis. Studies of zoster vaccine in such persons are
being conducted.
4.24.10 Precautions
If zoster vaccine is to be given around the same time as another live viral
parenteral vaccine (e.g. MMR, yellow fever), the vaccines should be given either
at the same visit or at least 4 weeks apart.
Laboratory testing to check for an immune response after zoster vaccination

is not recommended. Zoster vaccine boosts both humoral (IgG) and cellular
immune responses; however, confirmation of such immune responses is neither
necessary nor predictive of protection against the development of zoster.
Vaccination before or after immunoglobulin or blood product administration

Zoster vaccine can be given at any time before or after administration of
immunoglobulin or any antibody-containing blood product. This is because
zoster vaccine is indicated in persons who, because of their age, are assumed to
have had a previous VZV infection and, therefore, already have serum antibody
levels comparable to those found in blood products. (See also 3.3.4 Vaccination of
recent recipients of normal human immunoglobulin and other blood products.)

Persons receiving long-term salicylate therapy (aspirin) can be vaccinated if
indicated. There have been no reports of an association between Reye syndrome
and varicella vaccination, and it is unlikely that vaccination of a previously VZVinfected older person with zoster vaccine carries any risk of Reye syndrome.
Persons receiving antiviral medication

It is possible that the use of antivirals with anti-VZV activity, such as acyclovir,
famciclovir or valaciclovir, may interfere with the replication of the Zostavax
live attenuated virus. Persons on such antiviral medication should cease
treatment no less than 24 hours prior to vaccination and for at least 14 days after
vaccination.36,53

Injection site reactions (including erythema, pain, swelling and/or itch at the
injection site) occurred in approximately half of clinical trial participants given
Zostavax, irrespective of a previous history of HZ (see also 4.24.4 Vaccine above).
Varicella-like rashes at the injection site occurred rarely, in 0.1% of recipients;
however, they were more common than in placebo recipients. Varicella-like
rashes that were not localised to the injection site were also rare, and did not
occur more often in vaccine compared with placebo recipients (0.1% in both
groups). In the clinical trials in which rashes were analysed by PCR for VZV, the
majority were due to wild-type virus; only 2 subjects were found to have rashes
due to the Oka/Merck VZV vaccine strain (see also 4.24.4 Vaccine above).
Fever >38.3C was not seen more commonly in vaccine recipients, and occurred
in <0.1% of subjects overall.
Systemic symptoms were reported in vaccine recipients more commonly than in
placebo recipients (Zostavax 6.3% versus placebo 4.9%), with the most frequently
reported systemic symptoms being headache38 and fatigue.23
Post-marketing surveillance in the United States in a cohort of almost 200 000
adults who received the zoster vaccine found no increased risk for a number of
potential adverse events occurring after vaccination (such as cerebrovascular
events, encephalitis, etc.), but did find a 2-fold increased risk in the 1st week after
vaccination for events coded as allergic reactions, of which the majority were
injection site reactions.54
The product information for Zostavax states that the vaccine can be administered
concurrently with inactivated influenza vaccine but not with 23vPPV. The ATAGI
instead recommends that Zostavax may be administered concurrently with
other vaccines as indicated. The ATAGI also recommends that if inadvertent
concomitant administration of Zostavax and pneumococcal polysaccharide
vaccine occurs, there is no need to revaccinate.
The product information for Zostavax states that the safety and efficacy of
Zostavax have not been established in adults with known HIV infection,
with or without evidence of immunocompromise. The ATAGI recommends
instead that Zostavax may be administered to HIV-infected persons without
immunocompromise on a case-by-case basis, after seeking appropriate specialist
advice, and following confirmation of pre-existing immunity to VZV.
References
PART 5 PASSIVE IMMUNISATION

5.1 P
ASSIVE IMMUNISATION USING
IMMUNOGLOBULIN PREPARATIONS
Immunoglobulin preparations are used to provide passive immunisation, that
is, the direct administration of antibodies to a non-immune person to provide
immediate protection against infection or disease.
Immunoglobulin infusions are also indicated for some immunocompromised
persons who are antibody-deficient. In addition, immunoglobulins are also used
in the treatment of a number of specific immune-mediated conditions in order
to modulate the disease course. For further information regarding the use of
intravenous immunoglobulins, refer to Criteria for the clinical use of intravenous
immunoglobulin in Australia1 (www.nba.gov.au/ivig/index.html).
It is important to recognise that separate immunoglobulin preparations

are provided for intramuscular (IM) use and for intravenous (IV) use.
These have different properties, and the preparations should be given
only by the recommended route. Administration of IM immunoglobulin
by the IV route will lead to severe reactions. For more information
on intravenous immunoglobulin, refer to Criteria for the clinical use of
intravenous immunoglobulin in Australia.1
There are two types of immunoglobulin:

normal human immunoglobulin
specific immunoglobulins.
Normal human immunoglobulin (NHIG) is derived from the pooled plasma of
blood donors. It contains antibody to microbial agents that are prevalent in the
general population.
Specific immunoglobulin preparations are obtained from pooled blood
donations from patients convalescing from the relevant infection, donors recently
vaccinated with the relevant vaccine, or those who, on screening, have been
found to have sufficiently high antibody concentrations. These blood-derived
specific immunoglobulins therefore contain concentrations of antibody to an
individual organism or toxin at a higher titre than would be present in normal
immunoglobulin.
Donors of blood used for the production of NHIG and specific immunoglobulin
products are screened, and the products are treated to minimise the risk of
the immunoglobulin preparations containing HIV, hepatitis A, hepatitis B or

hepatitis C viruses, or parvovirus. Two dedicated pathogen inactivation steps
are incorporated into the manufacturing process. A pasteurisation step is usually
used during manufacture. The risk of prion transmission remains theoretical (see
www.transfusion.com.au/adverse_events/risks/estimates for further details).
5.1.1 Availability of immunoglobulins

CSL Limited supplies NHIG for IM use both directly to hospitals and to
the Australian Red Cross Blood Service. Rabies immunoglobulin, tetanus
immunoglobulin and botulism antitoxin can only be obtained by application to
state/territory health authorities. Respiratory syncytial virus (RSV) monoclonal
antibody (Synagis; Abbott Australia) is available commercially.
The Blood Service can be contacted by telephone nationally on 13 14 95; callers

will then be connected to the relevant state or territory Australian Red Cross
Blood Service branch.
Individual state or territory contact numbers:
02 6206 6024
New South Wales
1300 478 348
Northern Territory
08 8928 5116
Queensland
07 3838 9010
South Australia
08 8422 1201
Tasmania
03 6230 6209
Victoria
03 9694 0200
Western Australia
08 9421 2869

Store all immunoglobulins at +2C to +8C. Do not freeze. Protect from light.
5.1.3 Normal human immunoglobulin for intramuscular use

Normal human immunoglobulin (NHIG) is prepared by plasma fractionation
of blood collected from volunteer donors by the Australian Red Cross Blood
Service. It is a sterile solution of immunoglobulin, mainly IgG, and contains
those antibodies commonly present in adult human blood. In Australia, NHIG is
supplied as a 16% solution and made available through the Australian Red Cross
Blood Service.
PART 5 PASSIVE IMMUNISATION 457
5.1 PASSIVE IMMUNISATION

USING IMMUNOGLOBULIN
PREPARATIONS
Other specific immunoglobulins (for hepatitis B, cytomegalovirus, tetanus and

varicella-zoster), which are derived from Australian donated plasma, can be
obtained only from the Australian Red Cross Blood Service with permission from
an Australian Red Cross Blood Service medical officer. The Australian Red Cross
Blood Service supplies these products free of charge.
Normal Immunoglobulin-VF (human) (NHIG; for intramuscular use)

CSL Limited. 160mg/mL immunoglobulin (mainly IgG) prepared
from Australian blood donations. Supplied in 2mL and 5mL vials.
Also contains glycine.
Administration
NHIG should be given by deep IM injection, using an appropriately sized
needle. The NHIG should be introduced slowly into the muscle, to reduce pain.
This product must not be administered intravenously because of possible severe
adverse events, and hence an attempt to draw back on the syringe after IM
insertion of the needle should be made in order to ensure that the needle is not
in a small vessel. A special product for IV use (NHIG [intravenous]) has been
developed for patients requiring large doses of immunoglobulin. For further
information regarding the use of intravenous immunoglobulins, refer to Criteria
for the clinical use of intravenous immunoglobulin in Australia.1
Recommendations
Immunoglobulin preparations may be given to susceptible persons, as either
pre-exposure or post-exposure prophylaxis, against specific infections. Normal
pooled immunoglobulin contains sufficiently high antibody concentrations to
be effective against hepatitis A and measles. Both hepatitis A and measles are
notifiable diseases and further instructions about their management and the
need for immunoglobulin can be found in national guidelines (www.health.
gov.au/cdnasongs) and obtained from state/territory public health authorities
(see Appendix 1 Contact details for Australian, state and territory government health
The duration of effect of NHIG is dose-related. It is estimated that protection is
maintained for 3 to 4 weeks with standard recommended doses of NHIG.
Prevention of hepatitis A
Hepatitis A vaccination (see 4.4 Hepatitis A) is recommended in preference to

NHIG for post-exposure hepatitis A prophylaxis in persons 12 months of age
who are immunocompetent.
NHIG can be used when hepatitis A vaccine administration is contraindicated,
in infants <12 months of age, or in persons who are immunocompromised
and who might not mount a sufficient response following vaccination.2 NHIG
contains sufficiently high levels of antibody against hepatitis A to be able to
prevent or ameliorate infection in susceptible persons, if administered within
2 weeks of exposure.2
Prevention of measles
Measles vaccination (see 4.9 Measles) within 72 hours of case contact is

recommended in preference to NHIG for post-exposure measles prophylaxis in
many instances (see Table 4.9.2 in 4.9 Measles).
Immune deficiency
Patients with abnormal antibody production (primary

hypogammaglobulinaemia, multiple myeloma, chronic lymphoblastic
leukaemia) usually receive therapy with the IV preparation of normal human
immunoglobulin (NHIG [intravenous]). However, in some cases, NHIG is given
by IM injection. The aim of therapy is to maintain serum IgG levels above 6g/L.
Some patients may receive the IM (160mg/mL) preparation subcutaneously. For
further information regarding the use of intravenous immunoglobulins, refer to
Criteria for the clinical use of intravenous immunoglobulin in Australia.1
Note: Skin tests with NHIG should not be undertaken. The intradermal injection
of concentrated immunoglobulin causes a localised area of inflammation, which
can be misinterpreted as a positive allergic reaction. True allergic responses to
NHIG given by IM injection are extremely rare.
5.1.4 Specific immunoglobulins

Specific immunoglobulins are used to protect against specific microbial
agents such as hepatitis B, rabies and varicella-zoster viruses, and tetanus.
Further instructions about the management of these diseases and the need
for immunoglobulin should be obtained from state/territory public health
authorities (see Appendix 1 Contact details for Australian, state and territory
government health authorities and communicable disease control), and the national
guidelines for management of disease from rabies and other lyssaviruses,
including Australian bat lyssavirus (www.health.gov.au/cdnasongs).
Specific immunoglobulins for botulism and cytomegalovirus (CMV) and
a monoclonal antibody preparation for respiratory syncytial virus (RSV)
are available as described below. Potential interactions, adverse events and
storage requirements for these specific immunoglobulins are similar to those
for NHIG (IM).

PREPARATIONS
NHIG contains a sufficiently high concentration of antibody against measles

to be able to prevent or ameliorate infection in susceptible persons. NHIG
should be given as soon as possible and within 7 days of exposure.3 Passive
protection, against measles particularly, may be required if the exposed person
has an underlying immunological disorder (HIV/AIDS, immunosuppressive
therapy), or to control an outbreak of measles among non-immunised persons,
for example, in a childcare centre. The use of NHIG should be considered in
HIV-positive persons exposed to a patient with measles.
Hepatitis B specific immunoglobulin

Hepatitis B specific immunoglobulin (HBIG) is prepared from plasma donated
through routine blood bank collection. Stocks of HBIG are very limited, and use
should be strictly reserved for those who are at high risk, such as babies born
to mothers with chronic hepatitis B infection and non-immune persons who are
exposed through occupational exposure to the blood of unidentified persons, or
to persons who are chronically infected with hepatitis B or whose hepatitis status
cannot be ascertained in time.4 Requests for HBIG should be directed to the
Australian Red Cross Blood Service in your state/territory (see 5.1.1 Availability of
immunoglobulins above).
See 4.5 Hepatitis B, Management of infants born to mothers who are HBsAgpositive in 4.5.7 Recommendations and 4.5.11 Public health management of hepatitis B,
for more information.
Rabies specific immunoglobulin

Rabies specific immunoglobulin (HRIG) is prepared from the plasma of
hyperimmunised human donors. HRIG is only administered in persons who
have not received a previous course of rabies vaccine. HRIG is also administered
as part of the post-exposure prophylaxis used following potential Australian bat
lyssavirus or other lyssavirus exposures in previously unvaccinated persons.5
A single dose of HRIG is given to provide localised anti-rabies antibody
protection while the patient responds to the rabies vaccine. It should be given
at the same time as the 1st post-exposure dose of vaccine (day 0). If not given
with the 1st vaccine dose, it may be given up to day 7. From day 8 onwards, an
antibody response to rabies vaccine is presumed to have occurred.
The dose of HRIG is based on body mass and should be infiltrated in and
around all wounds, using as much of the calculated HRIG dose as possible.
The remainder of the HRIG dose should be administered intramuscularly at a
site away from the injection site of rabies vaccine.
See 4.16 Rabies and other lyssaviruses (including Australian bat lyssavirus) for more
information.
Varicella-zoster specific immunoglobulin

Zoster immunoglobulin (ZIG) is highly efficacious, but is often in short supply.
Normal high-titre zoster immunoglobulin is available from the Australian Red
Cross Blood Service on a restricted basis for the prevention of varicella in highrisk subjects who report a significant exposure to varicella or herpes zoster. If ZIG
is unavailable, large doses of NHIG can be given intramuscularly. This does not
necessarily prevent varicella, but it lessens the severity of the disease. ZIG has no
proven use in the treatment of established varicella or zoster infection. ZIG must
be given early in the incubation period (within 96 hours of exposure), but may
have some efficacy if administered out to as late as 10 days post exposure. ZIG
is able to prevent or ameliorate varicella in infants <1 month of age, in children
who are being treated with immunosuppressive therapy, and in pregnant

women.6,7 Patients suffering from primary or acquired diseases associated with
cellular immune deficiency and those receiving immunosuppressive therapy
should be tested for varicella-zoster antibodies following contact with a person
with confirmed varicella. However, this should not delay ZIG administration,
preferably within 96 hours and up to 10 days after initial exposure.7
See 4.22 Varicella for more information.
Botulism antitoxin
An intravenous botulinum antitoxin, produced in the United States (BabyBIG; its

sponsor is the Californian Department of Health Services), significantly reduces
the duration of mechanical ventilation and hospitalisation in infants with
botulism.9 This product has been administered to Australian children with infant
botulism.10 It is not currently registered in Australia, but is registered by the
United States Food and Drug Authority. Access to this product should be sought
through the TGAs Special Access Scheme.
Cytomegalovirus immunoglobulin
Cytomegalovirus (CMV) immunoglobulin is indicated for the prevention of CMV
infection in immunocompromised persons at high risk of severe CMV disease,
such as after bone marrow and renal transplants.11-13 The treatment of established
CMV infection and disease is primarily with antivirals, such as ganciclovir or
vanciclovir, and there is contradictory evidence whether the addition of CMV
immunoglobulin improves outcome.11,13
The product contains no antibacterial agent, and so it must be used immediately
after opening. Any unused portion must be discarded. If the solution has been
frozen, it must not be used. If the use of CMV immunoglobulin is contemplated,
detailed protocols for administration and management of adverse events should
be consulted, in addition to the product information.
CMV Immunoglobulin-VF (human) CSL Limited. 5565mg/mL
immunoglobulin (mainly IgG) prepared from human plasma with
high levels of antibody to CMV. Single vials contain 1.5 million units
of CMV immunoglobulin activity. Contains maltose.

PREPARATIONS
An equine antitoxin (derived from horses) has long been used in the treatment of
adult botulism, but has not been shown to be effective in infant botulism.8 Equine
antitoxin is manufactured by pharmaceutical companies such as Chiron. Use in
Australia is governed by the Therapeutic Goods Administrations Special Access
Scheme and physicians wishing to access this product should initially contact
the relevant state/territory health authority (see Appendix 1 Contact details for
Australian, state and territory government health authorities and communicable disease
control). Hypersensitivity, presenting as fever, serum sickness or anaphylaxis,
may follow the use of equine antitoxin. Skin testing followed by appropriate
dosing should be administered according to the manufacturers instructions.
Respiratory syncytial virus monoclonal antibodies

A humanised mouse monoclonal antibody to respiratory syncytial virus (RSV)
produced by cultured cells, palivizumab, is registered in Australia for prevention
of serious lower respiratory tract disease caused by RSV in children at high
risk of RSV disease. There is no consensus regarding the use of palivizumab
in Australia.14 This product is given by IM injection each month to children at
high risk of severe RSV disease, during the seasonal period of exposure to RSV.
Palivizumab has been found to reduce the absolute risk of hospitalisation from
about 10% to about 5% for babies born prematurely, for babies with chronic
neonatal lung disease, and also for babies with haemodynamically significant
congenital heart disease, particularly when complicated by large left-to-right
shunts leading to pulmonary hypertension.14-22 It has not been shown to reduce
the incidence of more severe outcomes, such as the need for ventilation, nor has it
been shown to reduce mortality.20,21 There are currently a number of clinical trials
assessing a recombinant humanised antibody, motavizumab.23
Synagis Abbott Australia (palivizumab). Supplied in single-use
vials of powder, to be reconstituted with sterile water for injection;
50mg in 4mL vial; 100mg in 10mL vial.
The dose of palivizumab is 15mg/kg once a month, to be given by IM injection,

preferably in the anterolateral thigh. Where possible, the 1st dose should be
administered before commencement of the RSV season.
Tetanus immunoglobulin
Tetanus immunoglobulin (human) for intramuscular use
Tetanus immunoglobulin (TIG) should be used for passive protection of

persons who have sustained a tetanus-prone wound, where the person has not
previously received 3 or more doses of a tetanus toxoid-containing vaccine or
where there is doubt about their tetanus vaccination status. In persons who have
a humoral immune deficiency, TIG should be provided after a tetanus-prone
injury, regardless of the time since their last dose of tetanus-containing vaccine.
TIG provides immediate protection that lasts for a period of 3 to 4 weeks.24 For
wounds not categorised as tetanus-prone, such as clean cuts, TIG is unnecessary.
Detailed information on appropriate tetanus prophylaxis measures in wound
management, including use of TIG, are outlined in Table 4.19.1 in 4.19 Tetanus.
The recommended dose for TIG is 250IU, to be given by IM injection as soon as
practicable after the injury. If more than 24 hours have elapsed, 500IU should be
given. Because of its viscosity, TIG should be given to adults using a 21 gauge
needle. For children, it can be given slowly using a 23 gauge needle. A tetanus
toxoid-containing vaccine should be given at the same time in the opposite
limb with a separate syringe, and arrangements should be made to complete

the full course of tetanus toxoid-containing vaccinations. Details for accessing
TIG should be obtained from the Australian Red Cross Blood Service (see 5.1.1
Availability of immunoglobulins above).
Tetanus immunoglobulin (human) for intravenous use
Tetanus Immunoglobulin-VF (human, for intravenous use) CSL

Limited. 5565mg/mL immunoglobulin (mainly IgG) prepared
from human plasma containing high levels of antibody to the toxin
of Clostridium tetani. Single vials containing 4000 IU human tetanus
antitoxin. Contains maltose.
Diphtheria antitoxin
Diphtheria antitoxin is prepared by immunising horses against the toxin
produced by Corynebacterium diphtheriae.
Advice should be sought with respect to diphtheria antitoxin access and dosage,
and special arrangements made if hypersensitivity is suspected; this can be
coordinated through the relevant state/territory health authority (see Appendix 1
5.1.5 Potential interaction with vaccines

Immunoglobulin preparations can interfere with the response to certain
live attenuated viral vaccines by preventing vaccine virus replication after
administration. Therefore, administration of live attenuated viral vaccines,
such as measles and varicella vaccines (but not rotavirus, zoster or yellow
fever vaccines), should be deferred, dependent on the clinical status of the
patient, for at least 3 months after the IM administration of NHIG, and for at
least 8 months after the administration of intravenous NHIG.25 For detailed
information on recommended intervals, see 3.3 Groups with special vaccination
requirements, Table 3.3.6 Recommended intervals between either immunoglobulins or
blood products and MMR, MMRV or varicella vaccination. For the same reason, if
vaccination has occurred, administration of immunoglobulin products should be

PREPARATIONS
Tetanus immunoglobulin for IV use (TIVG) is used in the management of clinical

tetanus.24 The recommended dose is 4000IU, to be given by slow intravenous
infusion. Detailed protocols for administration of this product and management
of adverse events should be consulted if its use is contemplated. Requests for
TIVG should be directed to the Australian Red Cross Blood Service in your state/
territory (see 5.1.1 Availability of immunoglobulins above).
deferred if possible until at least 3 weeks after a measles-containing or varicellacontaining vaccine has been given, unless it is essential that immunoglobulin be
administered. However, Rh (D) immunoglobulin (anti-D) does not interfere with
the antibody response to MMR- or varicella-containing vaccines and the two may
be given at the same time in different sites with separate syringes or at any time
in relation to each other (see 3.3 Groups with special vaccination requirements, Table
3.3.6 Recommended intervals between either immunoglobulins or blood products and
MMR, MMRV or varicella vaccination).
Inactivated vaccines
Inactivated vaccines, such as tetanus, hepatitis B or rabies, may be administered
concurrently with immunoglobulin preparations, or at any time before or after
receipt of immunoglobulin, using separate syringes and separate injection sites.
This usually would occur when there has been actual or possible acute exposure
to one of these infectious agents.
5.1.6 Use in pregnancy

Hypersensitivity reactions to immunoglobulin preparations occur rarely but
may be more common in patients receiving repeated injections. Intramuscular
immunoglobulins should not be administered to persons who have severe
thrombocytopenia or any coagulation disorder that would contraindicate
intramuscular injections.
5.1.8 Adverse events and precautions

Local tenderness, erythema and muscle stiffness at the site of injection occur very
commonly (in over 10% of recipients) and may persist for several hours after
injection. Systemic adverse events such as mild pyrexia, malaise, drowsiness,
urticaria and angioedema are uncommon, occurring in fewer than 1% of
recipients). Skin lesions, headache, dizziness, nausea, general hypersensitivity
reactions and convulsions may occur rarely.
Anaphylaxis following an injection of NHIG is very rare, but has been reported.
Anaphylaxis is more likely to occur if NHIG for IM use is inadvertently given
intravenously.
References

02 6289 1555
Freecall: 1800 671 811
Australian Childhood
Immunisation Register
enquiries (ACIR)
1800 653 809

ACIR email: [email protected]
ACIR Internet site: www.humanservices.gov.au/
customer/services/medicare/australian-childhoodimmunisation-register

Australian Capital
Territory
02 6205 2300
New South Wales
1300 066 055

Northern Territory
08 8922 8044
Queensland
13 HEALTH (13 4325 84)

South Australia
1300 232 272 (8.30 am to 5.00 pm)

Tasmania
03 6222 7666 or 1800 671 738
Victoria
1300 882 008

Western Australia
08 9388 4868
08 9328 0553 (after hours Infectious Diseases
Emergency)
Contact details for communicable disease control

Australian Capital
Territory
24-hour Communicable Disease Control Section:

02 6205 2155
New South Wales
1300 066 055

(for connection to Public Health Unit)
APPENDIX 1 465
appendix 1
APPENDIX 1: CONTACT DETAILS FOR AUSTRALIAN,

STATE AND TERRITORY GOVERNMENT
HEALTH AUTHORITIES AND
COMMUNICABLE DISEASE CONTROL*
Northern Territory
8.30 am to 5.00 pm: 08 8922 8044 Centre for Disease

Control
(After hours Royal Darwin Hospital 08 8922 8888 for
CDC on-call doctor)
Queensland
Contact your local Public/Population Health Unit,

phone number listed in the White Pages
South Australia
24 hour general enquiries line: 1300 232 272
Tasmania
24 hour hotline: 1800 671 738
Victoria
24 hour contact number: 1300 651 160
Western Australia
Perth Metropolitan area:

08 9388 4852
After hours/Emergency: 08 9328 0533
Outside Perth Metropolitan area:
Contact regional Population Health Unit
* See also state/territory and Therapeutic Goods Administration (TGA) contact details for
reporting AEFI in Table 2.3.3 Contact information for notification of adverse events following
immunisation in 2.3.2 Adverse events following immunisation.
For more information on other registers, see 2.3.4 Immunisation registers.
APPENDIX 2: LITERATURE SEARCH STRATEGY FOR

THE 10TH EDITION OF THE HANDBOOK
Table A2.1: Electronic databases searched for the 10th edition

Electronic database
Time period
MEDLINE
20062011
Cochrane Library including Cochrane Database of Systematic

Reviews, Database of Abstracts of Reviews of Effects, the
Cochrane Central Register of Controlled Trials (CENTRAL),
Methods Studies, the Health Technology Assessment Database,
the NHS Economic Evaluation Database
20062011
Cumulated Index Nursing & Allied Health Literature (CINAHL)

(when required)
20062011
Clinical Evidence
20062011
EMBASE
20062011
Australian focused Informit databases (AMI, APA-FT, APAIS,

APAIS - Health, ATSIhealth, Ausport Med, CINCH - Health,
DRUG, Health and Society, HIVA, Health Collection, Indigenous
Collection, RURAL, SAGE)
20062011
Searches were conducted using the electronic databases detailed in Table A2.1,
with the search period from 2006 to October 2011, in order to retrieve items
published since the searches completed for the 9th edition of the Handbook. The
scope of the searches was broad, to ensure maximum retrieval and minimise
the exclusion of items of interest. Previous Handbook searches were examined to
determine the scope required for the new searches, and similar search strategies
APPENDIX 2 467
appendix 2
For each Handbook chapter, broad literature searches were conducted for the years
since the last Handbook searches were performed, using up to 24 databases, listed
in Table A2.1. The purpose of these searches was to ensure that NCIRS technical
writers and ATAGI members had access to all relevant information from the
latest medical literature to allow identification of important issues related to
the updating of all Handbook chapters. In addition, since writing of the 9th
edition of the Handbook, Selected Dissemination Information (SDI) searches were
established to enable the ongoing collection of new relevant items on the search
topics. This process used the same search strategies as previously described,
which allowed consideration and inclusion of papers published since publication
of the 9th edition Handbook.
were employed to ensure consistency of information retrieval, taking into

account new terms added to the databases.
Various search methods were tested, including explode and focus options.
Exploded terms retrieve citations containing the term being searched and all
the narrower related terms in the database. Focus searches retrieve citations
that have the search term as the major focus of the item. In the trial searches,
some items of interest were missed using the focus method, thus exploded
searches were utilised. All subheadings assigned to the subject headings were
generally included. In general, the search strategy consisted of the disease topic
and relevant vaccine terms, used in combination with the terms immunisation/
immunisation programs. Boolean operators AND, OR and NOT were used as
appropriate. To ensure relevant and accurate retrieval, thesaurus terms (the
controlled vocabulary terms used in the database) were used whenever possible.
Keyword searching was used in the absence of an appropriate thesaurus term or
if the database did not have thesaurus terms. To facilitate relevant retrieval and
to limit what, in some instances, are very large search result sets, the following
limits were applied to the disease topic searches:
Publication year searches were generally limited to items published from
20062011.
Language searches were limited to items in English.
Human items discussing only animals were removed.
In vitro items discussing only in vitro studies were removed.
Abstracts search results restricted to items containing abstracts.
The search limits were slightly modified for some of the searches. For example,
the Australian-specific searches did not have search results limited to abstract
only, to ensure that all Australian items were retrieved.
The ATAGI and NCIRS technical writers also identified, where possible, focused
clinical questions for each of the Handbook chapters, in advance of conducting
literature searches. Specific searches were conducted for these questions, both
using the databases and time periods above, but also using additional databases,
longer time periods and other strategies, such as clinical trial registries and
handsearching, as necessary.
APPENDIX 3: COMPONENTS OF VACCINES USED IN THE

NATIONAL IMMUNISATION PROGRAM
For vaccines not listed in the National Immunisation Program, please refer
to individual product information leaflet as supplied with the vaccine, or the
Handbook chapter pertinent to that vaccine.
None of the vaccines listed on the National Immunisation Program contains
thiomersal.
Table A3.1: C
omponents of vaccines used in the National Immunisation Program
Vaccine
Vaccine brand
component*
Albumin/serum Avaxim
ProQuad
Quadracel
Aluminium
hydroxide
Vaqta
Varilrix
Varivax Refrigerated
Avaxim
Cervarix
Engerix-B
Havrix Junior
H-B-Vax II
Infanrix IPV
Menjugate Syringe
NeisVac-C
Vaqta
Antigen
Hepatitis A (HAV)
Measles-mumps-rubella-varicella (MMRV)
Diphtheria-tetanus-acellular pertussisinactivated poliomyelitis (DTPa-IPV)
Hepatitis A (HAV) paediatric/adolescent
Varicella (VV)
Varicella (VV)
Hepatitis A (HAV)
Hepatitis B (HBV) adult and paediatric
Hepatitis A (HAV) paediatric
Serogroup C meningococcal conjugate
(MenCCV)
(MenCCV)
APPENDIX 3 469
appendix 3
Please note that vaccine manufacture is subject to ongoing refinement and

change. Therefore, the information in Table A3.1 may change. This information
was current as of mid-2012 and has been sourced from the product information
(PI) of each vaccine listed. The Therapeutic Goods Administration provides the
most current versions of the PI and Consumer Medicines Information (CMI)
documents for vaccines (and other medicines) on its website at www.tga.gov.au.
Vaccine
component*
Aluminium
hydroxide/
phosphate
Vaccine brand
Antigen
Boostrix
Borax/sodium
borate
Gardasil
Diphtheria-tetanus-acellular pertussis
(dTpa) reduced antigen
Diphtheria-tetanus-acellular pertussishepatitis B-inactivated poliomyelitisHaemophilus influenzae type b
(DTPa-hepB-IPV-Hib)
(MenCCV)
(13vPCV)
Vaqta
Egg protein
All influenza vaccines

Agrippal
Influenza
Fluarix
Influenza
Fluvax
Influenza
Influvac
Influenza
Vaxigrip
Influenza
Adacel
Agrippal
Influenza
Avaxim
Hepatitis A (HAV)
Boostrix
Fluarix
Influenza
Havrix Junior
Infanrix hexa
Diphtheria-tetanus-acellular pertussishepatitis B-inactivated poliomyelitisHaemophilus influenzae type b (DTPa-hepBIPV-Hib)
Infanrix IPV
Influvac
Influenza
Quadracel
Vaqta
Vaxigrip
Influenza
Aluminium
phosphate
Gardasil
Infanrix hexa
Adacel
Meningitec
Prevenar 13
Quadracel
Formaldehyde
Vaccine
component*
Gelatin
Glutaraldehyde
Antigen
ProQuad
Fluarix
Influvac
Adacel
Agrippal
Priorix
Priorix-tetra
ProQuad
Varicella (VV)
Influenza
Influenza
Influenza
Varicella (VV)
Agrippal
Avaxim
Fluvax
Havrix Junior
Infanrix hexa
Influenza
Hepatitis A (HAV)
Influenza
Quadracel
Kanamycin
Mannitol
Monosodium
glutamate (MSG)
Neomycin
Infanrix IPV
Priorix
Priorix-tetra
ProQuad
Quadracel
Phenol
Vaqta
Varilrix
Vaxigrip
Pneumovax 23
Phenoxyethanol Adacel
Avaxim
Quadracel
Varicella (VV)
Varicella (VV)
Influenza
23-valent pneumococcal polysaccharide
(23vPPV)
Hepatitis A (HAV)
APPENDIX 3 471
appendix 3
Gentamicin
Vaccine brand
Vaccine
component*
Polymyxin
Vaccine brand
Antigen
Fluvax
Infanrix hexa
Influenza
Influenza
Influenza
Influenza
(13vPCV)
Rotavirus
Infanrix IPV
Quadracel
Polysorbate or
sorbitol
Agrippal
Boostrix
Fluarix
Gardasil
Havrix Junior
Infanrix hexa
Infanrix IPV
Influvac
Prevenar 13
Priorix
Priorix-tetra
ProQuad
Quadracel
Yeast
RotaTeq
Engerix-B
Gardasil
H-B-Vax II
Infanrix hexa
* If the person to be vaccinated has had an anaphylactic reaction to any of the vaccine components,
administration of that vaccine may be contraindicated. Specialist advice should be sought to
identify the component and to review if the person can be vaccinated in future.
Please also refer to Appendix 4 Commonly asked questions about vaccination for more specific
information about these various constituents.
APPENDIX 4: COMMONLY ASKED QUESTIONS

ABOUT VACCINATION
This appendix is divided into six sections:

General questions
Questions about contraindication and precautions
Questions about vaccine safety
Questions about vaccine content
Questions about the need for immunisation
Further information about vaccination
A.4.1 General questions

How does vaccination work?
When a healthy person becomes infected with a virus or bacteria (also known
as a pathogen), for example, the measles virus, the body recognises the virus as
an invader, produces antibodies that eventually destroy the virus, and recovery
occurs. If contact with the measles virus occurs again in the future, the bodys
immune system remembers the measles virus and produces an increase in
antibodies to destroy this pathogen.
Vaccination is the process that is used to stimulate the bodys immune system
in the same way as the real pathogen or disease would, but without causing the
symptoms of the disease. Most vaccines provide the body with memory so
that an individual does not get the disease if exposed to it (see 1.5 Fundamentals
of immunisation).
Vaccination conveys immunity to diseases by a process called active immunity,
which can be achieved by administration of either inactivated (i.e. not live) or
live attenuated pathogens or their products. Live vaccines are attenuated, or
weakened, by growing the organism through serial culturing (or passaging)
steps in various tissue culture media. Inactivation is usually done using
heat or formalin (sometimes both). Inactivated vaccines may include the
whole pathogen (such as oral cholera vaccine), the toxin produced by the
pathogen (such as tetanus and diphtheria vaccines), or specific antigens (such
as Haemophilus influenzae type b [Hib], meningococcal and pneumococcal
APPENDIX 4 473
appendix 4
This appendix contains information for providers to refer to when responding

to questions and concerns about immunisation. It covers general questions on
adult and childhood vaccination, including contraindications and precautions.
In addition, a discussion on some of the more recent concerns about vaccination
is included, covering issues relating to vaccine safety, vaccine content,
immunisation as a possible cause of some illnesses of uncertain origin, and the
need for vaccination.
vaccines). In some cases, the antigen is conjugated (i.e. chemically linked) with
proteins to facilitate the immune response. Inactivated viral vaccines may
include whole viruses (such as inactivated poliomyelitis vaccine [IPV] and
hepatitis A vaccines) or specific antigens (such as influenza and hepatitis B
vaccines). Live attenuated viral vaccines include measles-mumps-rubella
(MMR), varicella and yellow fever vaccines.
Immunity can also be acquired passively by the administration of
immunoglobulins, which are the same as antibodies (see 1.5 Fundamentals of
immunisation). Such immunity is immediate and is dose-related and transient.
For example, measles or hepatitis B immunoglobulin can be used promptly after
exposure in an unimmunised person to help reduce the chance of getting measles
or hepatitis B disease from the exposure.
What is the correct site for vaccination?

The top, outer part of the thigh (the vastus lateralis muscle) is the recommended
site for injections for infants <12 months of age. The deltoid region of the upper
arm is the recommended site for vaccination of all persons aged 12 months,
because it is associated with fewer local reactions and, in younger children, has
sufficient muscle bulk to facilitate the injection. However, the vastus lateralis
muscle can also be used in both young children and, where absolutely necessary,
adults.
The ventrogluteal area is an alternative site in children. (See 2.2.6 Recommended
injection sites and 2.2.8 Identifying the injection site).
Rotavirus vaccines are administered by the oral route and must never be injected.
How many injections can be given into the same limb, particularly in a
child aged <12 months?
More than one vaccine can be safely administered into a limb at the same
immunisation visit in either children or adults (See 2.2.9 Administering multiple
vaccine injections at the same visit).
Where more than one injection is required into the one limb, the injections should
be given at least 25mm (2.5cm) apart. Use separate sterile injection equipment
for each vaccine administered. The accompanying documentation should
indicate clearly which vaccines were given into which site (e.g. left arm upper/
left arm lower).
Most Australian states and territories have routine immunisation schedules that
include at least two injections during the primary course for children <12 months
of age. In this case, injections can be given into either the same leg, into the
vastus lateralis muscle, or the second injection can be given into the other vastus
lateralis muscle; an alternative is the ventrogluteal site.
When should preterm infants be vaccinated?
Do elderly people (>65 years) who have no chronic illnesses need the
influenza vaccine?
Yes. Age is an independent risk factor for severe influenza. Vaccination of those
aged >65 years, regardless of the presence or absence of chronic illness, reduces
mortality during the winter period in this age group (see 4.7 Influenza). The
healthy elderly should also receive the 23-valent pneumococcal polysaccharide
vaccine (see 4.13 Pneumococcal disease).
Should adults receive pertussis (whooping cough) vaccine boosters?

Yes. Two brands of acellular pertussis vaccines, both combined with tetanus and
diphtheria antigens, are now available for adolescents and adults. dTpa vaccines
are recommended in Australia for booster vaccination of individuals 10 years of
age who have previously had a primary course of diphtheria-tetanus-pertussis
vaccine. dTpa vaccines have a lower content of diphtheria and pertussis antigens
than DTPa formulations for young children.
A recent study showed that adults can be protected against pertussis after a
single dose of dTpa. No recommendations about the need for further boosters
using reduced antigen content formulation dTpa have been made at this time.
A single dose of dTpa is recommended for the following groups, unless
contraindicated or if they have already received a previous dose of dTpa in the
last 10 years (or 5 years when specifically indicated, see 4.12 Pertussis):
adults working with young children; vaccination is especially recommended
for those working in early childhood education and care
all healthcare workers
APPENDIX 4 475
appendix 4
Babies born at <32 weeks gestation or <2000g birth weight should receive their
1st dose of hepatitis B vaccine either at birth (within the first few days of life)
or at 2 months of age. The routine 2-month vaccines containing the antigens
diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirusHaemophilus influenzae type b (DTPa-hepB-IPV-Hib), Streptococcus pneumoniae
(13vPCV) and rotavirus should be given 2 months after birth as normal, unless
an infant is very unwell. Very unwell can be interpreted in many ways, but, in
general, reflects that the premature neonate is particularly medically unstable.
Delaying the 2-month vaccines is rarely required. If any preterm infant has the
2-month vaccines delayed, it should be remembered that the subsequent infant
doses can be given 1 month apart rather than 2 months. Hence, if an infant
receives the 2-month vaccines at 3 months of age then the 4-month vaccines
should still be given at 4 months of age. However, the 3rd dose of DTPa-hepBIPV-Hib should not be given before 6 months of age. Further explanation of the
special immunisation needs of premature babies is provided in 3.3.2 Vaccination
of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants.
adults planning a pregnancy, or both parents as soon as possible after

delivery of an infant (preferably before hospital discharge)
Pregnant women can also be vaccinated during the last trimester of
pregnancy, as an alternative to getting vaccinated straight after delivery. This
allows for antibodies to be transferred to the infant during the pregnancy
this particularly helps to protect the infant against pertussis. Other adult
household members, grandparents and carers of young children should
also be vaccinated. This recommendation is based on evidence from several
studies of infant pertussis cases, in which family members, particularly
parents, were identified as the source of infection in more than 50% of cases,
and were the presumed source in a higher proportion.
any adult expressing an interest in receiving a booster dose of dTpa.
Adults 50 years of age who have not previously received dTpa vaccine should
also be offered vaccination (see 4.2 Diphtheria, 4.12 Pertussis or 4.19 Tetanus in this
Handbook).
Contraindications to the reduced antigen content formulation dTpa are discussed
in 4.2 Diphtheria, 4.12 Pertussis and 4.19 Tetanus in this Handbook and include
previous anaphylactic reaction to any vaccine component.
If the patient has never received a primary course of dT, see 4.2 Diphtheria,
4.12 Pertussis or 4.19 Tetanus in this Handbook.
A person wants to receive his/her vaccines separately. Why cant they do this?
There is no scientific evidence or data to suggest that there are any benefits
in receiving vaccines such as MMR as separate monovalent vaccines. Using
the example of MMR vaccine, there is no individual mumps, measles or
rubella vaccine approved for use in Australia. If these vaccines were to be
administered individually, it would require three separate vaccines, which would
unnecessarily increase discomfort for the child. In addition, if these monovalent
vaccines were not given on the same day, they would need to be spaced 1 month
or more apart, which would increase the risk of that person being exposed to
serious vaccine-preventable diseases. A policy of providing separate vaccines
would cause some people to not receive the entire course. Combination vaccines
can offer a reduced amount of vaccine preparation to be injected overall,
compared to three individual vaccine doses.
Is vaccination compulsory? What happens if children do not get vaccinated?

Vaccination is not compulsory in Australia.
Eligibility for the Family Tax Benefit Part A supplement will require either that
children are assessed as fully immunised or that the parent has obtained an
appropriate medical or philosophical exemption. This replaced the Maternity
Immunisation Allowance on 1 July 2012.
A4.2 Questions about contraindications and precautions

If a person has any concerns about whether to proceed with vaccination, they
should be provided with appropriate information and encouraged to obtain
expert advice from their usual immunisation provider or an immunisation
specialist, if necessary. See Appendix 1 Contact details for Australian, state
and territory government health authorities and communicable disease control for
contact details.
What are the absolute contraindications to childhood vaccination?

True contraindications to vaccines are extremely rare (see relevant chapters),
and include only anaphylaxis to any of the particular vaccines components,
and anaphylaxis following a previous dose of that vaccine. Follow-up specialist
medical advice should always be sought if any severe reaction or anaphylaxis has
occurred following the administration of any vaccine(s).
Note: Anaphylaxis following ingestion of eggs does not contraindicate MMR
vaccine, as the vaccine viruses are not grown in eggs and the vaccine does not
contain any egg protein (see 4.9 Measles). Many persons who have a history of a
severe allergic reaction to eggs can also be vaccinated with influenza vaccine (see
4.7 Influenza).
Can someone who has had whooping cough (pertussis) still be vaccinated?
Vaccination with pertussis vaccine in children, adolescents or adults who have
had laboratory-confirmed pertussis infection is safe and is necessary, as natural
immunity does not confer life-long protection. In particular, incompletely
vaccinated infants <6 months of age who develop pertussis may not mount an
adequate immune response following infection and should receive all routinely
scheduled vaccines, including pertussis-containing vaccines (see 4.12 Pertussis).
What are the precautions to vaccination?

In general, persons with impaired immunity or on immunosuppressive therapy,
or pregnant women, should not be given live vaccines. However, any general
concerns that the person to be vaccinated or the parent/carer holds should
always be fully discussed prior to the administration of any vaccine.
APPENDIX 4 477
appendix 4
If a parent decides not to have a child vaccinated and, if cases of certain vaccinepreventable diseases occur at that childs day-care centre or school, the parent
may, in some circumstances, be required to keep the unvaccinated child at home
until the incubation period for that particular disease has passed or no further
cases have occurred in that setting.
Should a person with an intercurrent illness be vaccinated?

A child or adult with a minor illness (without systemic illness and with a
temperature <38.5C) may be safely vaccinated. People, including infants,
toddlers and teenagers with minor coughs and colds without fever, or those
receiving antibiotics in the recovery phase of an acute illness, can be vaccinated
safely and effectively. In a person with a major illness or high fever 38.5C,
vaccination should be postponed until they are well. If vaccination were to be
carried out during such an illness, the fever might be confused with vaccine
side effects and might also increase discomfort to the person. In such cases,
it is advisable to defer vaccination and arrange for the person to return for
vaccination when well again (see Table 2.1.2 Responses to relevant conditions or
circumstances identified by the pre-vaccination screening checklist).
Should persons with epilepsy be vaccinated?

Yes. Stable neurological conditions (such as epilepsy) are not a reason to avoid
giving any vaccines, including pertussis (whooping cough). Children and
adults who are prone to fits should have paracetamol before and for 48 hours
after vaccination to reduce the chance of a fever after vaccination bringing
on a convulsion. A family history of fits or epilepsy is not a reason to avoid
vaccination.
Should persons with a neurological disease or conditions receive the normal

vaccination schedule?
Yes. Persons with a neurological disease are often at increased risk of
complications from diseases like measles, influenza and whooping cough, as they
can be more prone to respiratory infections and chest problems. It is important
that these children be immunised, on time, as recommended in the National
Immunisation Program schedule.
Are steroids a contraindication to vaccination?

Live vaccines, such as MMR, measles-mumps-rubella-varicella (MMRV), bacille
Calmette-Gurin (BCG) and varicella-zoster vaccines, should not be given to
children or adults receiving high-dose oral or parenteral corticosteroid therapy
for more than 1 week. High-dose oral corticosteroid therapy is defined as more
than 2mg/kg per day prednisolone for more than 1 week in children, or more
than 60mg per day for more than 1 week in adults. This is because steroids, in
large doses, greatly suppress the immune system, which means that, not only is
the vaccine unlikely to be effective, but there is an increased chance of an adverse
event occurring as a result of the immunosuppression (see 3.3.3 Vaccination of
immunocompromised persons).
Inactivated vaccines, for example, DTPa-hepB-IPV-Hib or hepatitis B, may be less
effective in this group, but are not contraindicated. Therapy with inhaled steroids
is not a contraindication to vaccination.
Should vaccines be given to persons who have problems with their

immune systems?
HIV-infected persons may be given MMR, varicella and zoster vaccines,

provided they do not have severe immunocompromise (see 3.3 Groups with special
vaccination requirements and Table 3.3.4 Categories of immunocompromise in HIVinfected persons, based on age-specific CD4+ counts and percentage of total lymphocytes).
The close contacts of persons who are immunocompromised can be given live
viral vaccines, except oral polio vaccine, which is no longer used in Australia.
The rash seen in a small percentage of MMR vaccine recipients, usually between
5 and 12 days after vaccination, is not infectious. Non-immune household
contacts of persons who are immunocompromised should receive varicella
vaccine. There is an almost negligible risk of transmitting varicella vaccine virus
from a vaccine-related vesicular rash to contacts. However, vaccine-related
rash occurs in 3 to 5% of vaccinated persons, either locally at the injection site
or generalised, with a median of only 25 lesions. This small infection risk of the
less virulent attenuated vaccine strain is far outweighed by the high risk of nonimmune contacts catching wild varicella infection and transmitting the virus
to the immunocompromised household member via respiratory droplets or
from the large number of skin lesions that occur with wild varicella infection (a
median of 300 to 500 lesions).
Live viral vaccines can be given to persons with leukaemia and other
malignancies at least 3 months after they have completed chemotherapy,
provided there are no concerns about their immune status. Such measures would
normally be carried out under the supervision of the persons oncologist (see
3.3.3 Vaccination of immunocompromised persons).
What vaccines should someone with HIV infection receive?

Persons with HIV (human immunodeficiency virus) infection, especially
children, should have all routine inactivated vaccines on the National
Immunisation Program schedule. Varicella vaccine is contraindicated in
persons with HIV who are significantly immunocompromised, as it can
cause disseminated varicella infection. However, it may be considered for
asymptomatic or mildly symptomatic HIV-infected children, after weighing
up the potential risks and benefits. This should be discussed with the childs
specialist. MMR vaccine can be given to children with HIV, depending on their
CD4+ counts (see Should vaccines be given to persons who have problems
with their immune systems? above). Persons with HIV infection should also
be vaccinated against pneumococcal disease (see 4.13 Pneumococcal disease).
Influenza vaccine is also recommended for HIV-infected persons. They should
APPENDIX 4 479
appendix 4
Persons who are immunocompromised (from either a disease or medical

treatment) should generally not be given live viral vaccines such as MMR,
MMRV, varicella, zoster or rotavirus vaccines (see 4.9 Measles, 4.22 Varicella,
4.24 Zoster and 4.17 Rotavirus).
not be given BCG, due to the risk of disseminated infection. More detailed
information on the use of vaccines in persons with HIV is included in 3.3.3
Vaccination of immunocompromised persons.
Should chronically ill persons be vaccinated?

In general, persons with chronic diseases should be vaccinated as a matter of
priority, because they are often more at risk from complications from vaccinepreventable diseases. Annual influenza vaccine is highly recommended for
chronically ill persons and their household contacts.
Care is needed with the use of live attenuated viral vaccines in situations
where the persons illness, or its treatment, may result in impaired immunity.
Advice may need to be sought on these patients to clarify the safety of live
viral vaccine doses.
Should children or household contacts be vaccinated while the childs

mother is pregnant?
There is no problem with giving routine vaccinations to a child, or others, living
in the same household with a pregnant woman. MMR vaccine viruses are not
transmissible. Administration of varicella vaccine to household contacts of
non-immune pregnant women is safe. Transmission of varicella vaccine virus
is very rare. There is an almost negligible risk of transmitting varicella vaccine
virus from a vaccine-related vesicular rash to contacts. However, vaccine-related
rash occurs in 3 to 5% of vaccinated persons, either locally at the injection site or
generalised, with a median of only 25 lesions. Furthermore, vaccinating the child
of a pregnant mother will reduce the risk of her being infected by her offspring
with the more virulent wild virus strain if she is not immune (see 3.3.2 Vaccination
of women who are planning pregnancy, pregnant or breastfeeding, and preterm infants).
Should persons with allergies be vaccinated? What precautions are required for
atopic or egg-sensitive children or adults?
Depending on the allergy identified, there often may not be a contraindication
to vaccination. Specialist medical advice should always be sought in order to
determine which vaccinations can be safely given. For example, a history of an
allergy to antibiotics most commonly relates to -lactam, or related antibiotics,
and is not a contraindication to vaccines that contain neomycin, polymyxin B
or gentamicin. Previous reactions to neomycin that only involved the skin
are not considered a risk factor for a severe allergic reaction or anaphylaxis to
vaccines manufactured with neomycin, since there are only trace amounts of
this antibiotic in the final product (see 3.3.1 Vaccination of persons who have had an
adverse event following immunisation).
For other allergies, see Appendix 3, Components of vaccines used in the National
Immunisation Program, and the relevant vaccine product information (PI) enclosed
in the vaccine package. Unless the person being vaccinated has an allergy to a
specific constituent of a vaccine (or has another contraindication), there is no
reason not to vaccinate. Asthma, eczema and hay fever are not contraindications
to any vaccine, unless the child/adult is receiving high-dose oral steroid therapy.
A history of anaphylaxis or allergy to egg had previously been considered an

absolute contraindication to influenza vaccination, but there have now been
a number of studies indicating that the majority of such persons can be safely
vaccinated.1,2 Given that there is still a small risk of anaphylaxis, it is essential
that such persons are vaccinated in facilities with staff able to recognise and treat
anaphylaxis. (See also 4.7 Influenza.)
Yellow fever, Q fever and one of the available rabies vaccines contain a higher
amount of egg albumin than is present in the currently available influenza
vaccines. Persons with egg allergy requiring vaccination with either yellow fever,
rabies or Q fever vaccines, should seek specialist immunisation advice from their
state or territory health department. See also relevant chapters of this Handbook.
Families with questions about allergies and vaccines are encouraged to discuss
this with their immunisation service provider and, where necessary, seek
referral to an immunologist to have any questions promptly answered to avoid
unnecessary delays of vaccine doses or referral to a specialist immunisation
clinic. Information on specialist immunisation clinics is available from your local
state or territory health department. (See Appendix 1 for further details.)
A4.3 Questions about vaccine safety

Some people have concerns about immunisation. These mostly relate to whether
the vaccine is safe and whether vaccines weaken the immune system. Providers
should always listen to and acknowledge peoples concerns. Providers should
discuss the risks and benefits of immunisation with parents/carers honestly and
in a non-defensive manner. Parents/carers and adult vaccine recipients should
receive accurate information on the risks from vaccine-preventable diseases and
information about vaccine side effects and adverse events (see table Comparison
of the effects of diseases and the side effects of NIP vaccines inside the back cover of
this Handbook). The following section responds to some concerns raised about the
safety of immunisation, and examines the scientific evidence in order to assist
providers and parents in making an informed choice about the risks and benefits
of vaccination.
APPENDIX 4 481
appendix 4
Persons with egg allergies can receive MMR vaccines because the measles and
mumps components of MMR vaccine do not contain sufficient amounts of egg
ovalbumin to contraindicate MMR vaccination of people with egg allergy (even
anaphylaxis) (see 3.3.1 Vaccination of persons who have had an adverse event following
immunisation and 4.9 Measles). A simple dislike of eggs, or having diarrhoea or
stomach pains after eating eggs, are not reasons to avoid MMR vaccination, and
no special precautions are required in these circumstances. These persons can
also have all other routine vaccines without special precautions.
How safe are vaccines?

Before vaccines are made available for general use they are tested for safety
and efficacy in clinical trials and then in large trials, otherwise known as phase
II (2) and III (3) trials. All vaccines marketed in Australia are manufactured
according to strict safety guidelines and are evaluated by the Therapeutic Goods
Administration, to ensure they are efficacious and are of adequate quality and
safety, before marketing approval is granted.
After vaccines are introduced into vaccination schedules, they are subjected to
continuing surveillance of efficacy and safety through trials and post-marketing
surveillance. In Australia, there are regional and national surveillance systems
actively seeking any adverse events following immunisation. This is necessary,
as sometimes unexpected side effects occur after vaccines are registered for use.
Australian reports on adverse events that occur following immunisation are
published on a 6-monthly basis in the journal Communicable Diseases Intelligence
(www.health.gov.au/internet/main/publishing.nsf/content/cda-pubs-cdicdiintro.htm).
Can too many vaccines overload or suppress the natural immune system?
No. Although the increase in the number of vaccines and vaccine doses given
to children has led to concerns about the possibility of adverse effects of the
aggregate vaccine exposure, especially on the developing immune system, there
is not a problem. In day-to-day life, all children and adults confront enormous
numbers of antigens, and the immune system responds to each of these in
various ways to protect the body. Studies of the diversity of antigen receptors
indicate that the immune system can respond to an extremely large number of
antigens. In addition, the number of antigens received by children during routine
childhood vaccination has actually decreased compared with several decades
ago. This has occurred in spite of the increase in the total number of vaccines
given, and can be accounted for by the removal of two vaccines smallpox
vaccine (which contained about 200 different proteins), and whole-cell pertussis
vaccine (about 3000 distinct antigenic components) from routine vaccination
schedules. In comparison, the acellular pertussis vaccine currently used in
Australia has only 3 to 5 pertussis antigens.3
Do vaccines cause disease?

Some studies have suggested a temporal link between vaccinations and
certain medical conditions, such as asthma, multiple sclerosis and diabetes.
The questions of a link are often made for a disease of unknown cause. The
appearance of a certain medical condition after vaccination does not necessarily
imply that they are causally related. Importantly, however, once an issue is raised
it needs prompt research, discussion and then education to avoid creating a
myth. In many cases, subsequent epidemiological studies have indicated that the
association is due to chance alone. The following is a list of concerns that have
been raised.
Does MMR vaccine cause inflammatory bowel disease or autistic spectrum disorder?
No.
An extensive review published in 2004 by the Institute of Medicine (IOM),

an independent expert body in the United States, concluded that there is no
association between the MMR vaccine and the development of autism. A 2011
update by the IOM continues to reject any causal association between MMR
vaccine and autism (see www.iom.edu/vaccineadverseeffects).
See 4.9 Measles for further information. There is also an MMR vaccine decision
aid designed for parents available at www.ncirs.edu.au/decisionaid/index.html.
Do childhood immunisations cause asthma?
There is no evidence that vaccination causes or worsens asthma. It is especially

important that children with asthma be vaccinated like other children, as
catching a disease like whooping cough can make an asthma attack worse.
Although influenza vaccine is not routinely recommended for all asthmatics,
it is recommended for severe asthmatics, such as those requiring frequent
hospitalisation (see 4.7 Influenza).
Does influenza vaccine cause flu?
No. It is not possible for influenza vaccine to cause flu as it is not a live viral
vaccine. (Note: a live attenuated influenza vaccine is used in some countries, but
not in Australia.) As some people experience side effects such as a mild fever
after the vaccine, it is understandable that they may confuse these symptoms
with actually having the flu. In addition, the influenza vaccine is recommended
to be given at the commencement of the flu season. Hence, it is possible that
a person who has contracted, and is incubating, influenza during vaccination
will mistakenly believe the vaccine to be causal. In addition, influenza vaccine
is given at the very time of year when there are a lot of upper respiratory tract
infections (URTIs) around. It is not uncommon for someone to attribute an URTI
within a week of an influenza vaccine to the vaccine dose. Importantly, URTI
symptoms occurring after influenza vaccine should not put people off having the
vaccine the following year.
APPENDIX 4 483
appendix 4
In 1998, Wakefield et al. (Royal Free Hospital, London) published a case-series

study with 12 children suggesting that MMR vaccine caused inflammatory bowel
disease (IBD), which then resulted in decreased absorption of essential vitamins
and nutrients through the intestinal tract. They proposed that this could result in
developmental disorders such as autism. The Lancet retracted this publication in
2010 and the British Medical Council struck off the lead author in 2010, following
the British General Medical Councils Fitness to Practice Panel finding the author
guilty of serious professional misconduct.
A4.4 Questions about vaccine content4

See also Table A3.1 Components of vaccines used in the National Immunisation
Program in Appendix 3. Refer also to the product information (PI) or the
consumer medicines information (CMI) for individual vaccines; both are
available from the TGA website (www.tga.gov.au).
Preservatives
Preservatives are used to prevent fungal and or bacterial contamination of the
vaccine. They include thiomersal, phenoxyethanol and phenol.
Thiomersal
Thiomersal (or thimerosal) is a compound that is partly composed of a form of

mercury called ethylmercury. It has been used in very small amounts in vaccines
for about 60 years to prevent bacterial and fungal contamination of vaccines. In
the past, the small amount of thiomersal in vaccines was one of several potential
sources of mercury. Diet (such as some seafood) and other environmental sources
are also possible sources of mercury. Vaccines used in the past, such as DTP,
contained only 25g of thiomersal per dose.
Mercury causes a toxic effect after it reaches a certain level in the body. Whether
or not it reaches a toxic level depends on the amount of mercury consumed and
the persons body weight; individuals with very low body weight are usually
more susceptible to toxic effects from a certain intake of mercury. Thus, the
possibility existed that vaccination of newborn babies, particularly those of very
low birth weight, with repeated doses of thiomersal-containing vaccines might
have resulted in levels of mercury above the recommended guidelines.
Thiomersal was removed from vaccines in response to the above theoretical
concern and to reduce total exposure to mercury in babies and young children in
a world where other environmental sources may be more difficult to eliminate.5-7
Currently, all vaccines on the NIP for children and adolescents are free of
thiomersal.
Phenoxyethanol
The aromatic ether alcohol, 2-phenoxyethanol, is used as a preservative in many

vaccines, and also as a preservative in cosmetics. It is used in vaccines as an
alternative preservative to thiomersal.
Phenol
Phenol is an aromatic alcohol used as a preservative in a few vaccines.
Adjuvants
Adjuvants are compounds used to enhance the immune response to vaccination
and include various aluminium salts, such as aluminium hydroxide, aluminium
phosphate and potassium aluminium sulphate (alum). A review of all available
studies of aluminium-containing diphtheria, tetanus and pertussis vaccines
(either alone or in combination) found no evidence that aluminium salts in

vaccines cause any serious or long-term adverse events.8
Aluminium
Additives
Additives are used to stabilise vaccines in adverse conditions (temperature
extremes of heat and freeze drying) and to prevent the vaccine components
adhering to the side of the vial.
Examples of additives include:
lactose and sucrose (both sugars)
sorbitol and mannitol (both sugar alcohols)
polysorbate 80, made from sorbitol and oleic acid (an omega fatty acid)
glycine and monosodium glutamate or MSG (both are amino acids or salts of
amino acids)
gelatin, which is partially hydrolysed collagen, usually of bovine or porcine
origin, although information on the source of gelatin is not routinely
provided in the product information for all vaccines.
Some members of the Islamic and Jewish faiths may object to vaccination,
arguing that vaccines can contain pork products. However, scholars of
the Islamic Organization for Medical Sciences have determined that the
transformation of pork products into gelatin will sufficiently alter them,
thus making it permissible for observant Muslims to receive vaccines, even
if the vaccines contain porcine gelatin. Likewise, leaders of the Jewish faith
have also indicated that pork-derived additives to medicines are permitted.
Further information may be obtained from the following websites
APPENDIX 4 485
appendix 4
A small amount of aluminium salts has been added to some vaccines for
about 60 years. Aluminium acts as an adjuvant, which improves the protective
response to vaccination by keeping antigens near the injection site so they can
be readily accessed by cells responsible for inducing an immune response. The
use of aluminium in vaccines means that, for a given immune response, less
antigen is needed per dose of vaccine, and a lower number of total doses are
required. Although aluminium-containing vaccines have been associated with
local reactions and, less often, with the development of subcutaneous nodules at
the injection site, other studies have reported fewer reactions with aluminiumadsorbed vaccines than with unadsorbed vaccines. Concerns about the longerterm effects of aluminium in vaccines arose after some studies suggested a link
between aluminium in the water supply and Alzheimers disease, but this link
has never been substantiated. The amount of aluminium in vaccines is very
small and the intake from vaccines is far less than that received from diet or
medications such as some antacids.9,10
www.vaccinesafety.edu/Porcine-vaccineapproval.htm and www.immunize.

org/concerns/porcine.pdf
human serum albumin (protein).
Manufacturing residuals
Manufacturing residuals are residual quantities of reagents used in the
manufacturing process of individual vaccines. They include antibiotics (such
as neomycin or polymyxin), inactivating agents (e.g. formaldehyde) as well
as cellular residuals (egg and yeast proteins), traces of which may be present
in the final vaccine. Antibiotics are used during the manufacturing process to
ensure that bacterial contamination does not occur; traces of these antibiotics
may remain in the final vaccine. Inactivating agents are used to ensure that
the bacterial toxin or viral components of the vaccine are not harmful, but will
result in an immune response. Cellular residuals are minimised by extensive
filtering. However, trace amounts may be present in the final product. The most
commonly found residual is formaldehyde.
Formaldehyde
Formaldehyde is used during the manufacture of many vaccines. For example,

with tetanus vaccines, formaldehyde is used to detoxify the tetanus toxin protein
produced. The non-toxic protein, which becomes the active ingredient of the
vaccine, is further purified to remove contaminants and any excess (unreacted or
unbound) formaldehyde. The current standard applicable to vaccines for human
use in Australia is less than 0.02% w/v of free formaldehyde. The maximum
amount of free formaldehyde detected by the Therapeutic Goods Administration
during testing of vaccines registered in Australia has been 0.004% w/v, which is
well below the standard limit.
Other ingredients and information about manufacturing

Vaccines also may be made up in sterile water or sterile saline (salt-water).
Some viruses used in vaccines require the use of cell lines in which to grow the
vaccine virus. The cell lines are not included as a component of the vaccine. Some
of these cell lines (called human diploid cell lines WI-38 and MRC-5) were
originally derived from human fetal tissue in the 1960s. These cell lines have
been growing under laboratory conditions for more than 40 years, and there has
been no further fetal tissue obtained since the 1960s. The vaccines manufactured
using viruses that were grown in these cell lines include rubella vaccine and
MMR vaccine, hepatitis A vaccines, varicella vaccines, rabies vaccine and oral
polio (Sabin) vaccine (no longer available in Australia). Many of these vaccines
prevent severe disease in unborn babies and infants, including, most notably,
rubella, which causes congenital rubella syndrome.
A4.5 Questions about the need for immunisation

Isnt natural immunity better than immunity from vaccination?
Diseases like measles, polio and diphtheria have already disappeared from
most parts of Australia. Why do we need to keep vaccinating children against
these diseases?
Although these diseases are much less common now, they still exist. The
potential problem of disease escalation is kept in check by routine vaccination
programs. In countries where vaccination rates have declined, vaccinepreventable diseases have sometimes reappeared. For example, Holland has one
of the highest rates of fully vaccinated people in the world. However, in the early
1990s, there was a large outbreak of polio among a group of Dutch people who
belonged to a religious group that objected to vaccination. While many of these
people suffered severe complications like paralysis, polio did not spread into the
rest of the Dutch community. This was due to the high rate of vaccination against
polio, which protected the rest of the Dutch community.
There have been recent outbreaks of whooping cough, measles and rubella
in Australia, and a number of children have died. Cases of tetanus and
diphtheria, although rare, still occur. Thus, even though these diseases are
much less common now than in the past, it is necessary to continue to protect
Australian children, so that the diseases cannot re-emerge to cause large
epidemics and deaths.
Also, many of the diseases against which we vaccinate our children are still
common in other areas of the world. For example, measles still occurs in many
Asian countries, where many people take holidays or travel for business.
Therefore, it is possible for non-immune individuals to acquire measles
overseas, and, with the speed of air travel, arrive home and be able to pass
measles onto those around them if they are unprotected. Measles is highly
infectious and can infect others for several hours after an infected person has
left a room. Vaccination, while not 100% effective, can considerably minimise
a persons chance of catching a disease. The more people who are vaccinated,
the less chance there is that a disease, such as measles, will spread widely in the
community. This is referred to as herd immunity.
APPENDIX 4 487
appendix 4
While vaccine-induced immunity may diminish with time without boosters

(vaccine or contact with wild-type infection), natural immunity, acquired by
catching the disease, is usually life-long, with the exception of pertussis. The
problem is that the wild or natural disease has a higher risk of serious illness
and occasionally death. Children or adults can be revaccinated (with some, but
not all, vaccines) if their immunity from the vaccines falls to a low level or if
previous research has shown that a booster vaccination is required for long-term
protection. It is important to remember that vaccines are many times safer than
the diseases they prevent.
Why do some children get the disease despite being vaccinated?

This is possible because a small proportion of those who are vaccinated will
remain susceptible to the disease. However, in the cases in which illness does
occur in vaccinated individuals, the illness is usually much less severe than in
those who were not vaccinated. The protection provided by the same vaccine
to different individuals can differ. For example, if 100 children are vaccinated
with MMR, 5 to 10 of the 100 fully vaccinated children might still catch measles,
mumps or rubella (although the disease will often be less severe in vaccinated
children). If 100 children are vaccinated with a full schedule of pertussiscontaining vaccines, 20 of the children might still get whooping cough, but,
once again, the disease is often less severe in these vaccinated children. To put
it another way, if you do not vaccinate 100 children with MMR vaccine, and the
children are exposed to measles, all of them will catch the disease with a risk
of high rates of complications like pneumonia or encephalitis. The reason why
fewer children become infected than these figures suggest is due to the high
vaccine coverage rates in the community. If there are high coverage rates, there
is less chance of contact with the infection and, although some children may be
susceptible, they have a low chance of contact with the infection (this situation is
also called herd immunity).
What about homeopathic immunisation?

Homeopathic immunisation has not been proved to give protection against
infectious diseases; only conventional vaccination produces a measurable
immune response. The Council of the Faculty of Homeopathy, London, issued a
statement in 1993, which reads: The Faculty of Homeopathy, London, strongly
supports the conventional vaccination program and has stated that vaccination
should be carried out in the normal way, using the conventional tested and
proved vaccines, in the absence of medical contraindications.11
A4.6 Further information about vaccination

More information about vaccination can be found in the following publications
produced by the Australian Government Department of Health:
Understanding childhood immunisation
Immunisation myths and realities responding to arguments against immunisation:
a guide for providers.
The following two websites include further publications, fact sheets, etc. and are
recommended for both immunisation service providers and the general public:
Immunise Australia website www.immunise.health.gov.au
The National Centre for Immunisation Research and Surveillance of Vaccine
Preventable Diseases (NCIRS) website www.ncirs.edu.au.
Also, check with your local state or territory Public Health Unit or local
council, maternal child health nurse or public health vaccination clinic for more
information (see Appendix 1 Contact details for Australian, state and territory
References
APPENDIX 5: GLOSSARY OF TECHNICAL TERMS

Adjuvant
a preparation added to a vaccine to improve the immune response to that vaccine
Anaphylaxis
a sudden and severe allergic reaction, which results in a serious fall in blood
pressure and/or respiratory obstruction and may cause unconsciousness and
death if not treated immediately
Attenuation
the process of modifying a virus or bacteria to reduce its virulence (diseaseinducing ability) while retaining its ability to induce a strong immune response
(immunogenicity)
Bacteria
microorganisms that are smaller than a blood cell, but bigger than a virus;
examples of bacterial infections are diphtheria, tetanus, pertussis, Hib and
tuberculosis
Brachial neuritis
pain in the arm, causing persisting weakness of the limb on the side of
vaccination
Chronically infected
formerly referred to as a carrier; a person who has an infection that, although
not necessarily causing symptoms, may still be active and may spread to others;
chronic infection may last for years; examples of infections that can result in
chronically infected states are hepatitis B and typhoid
Conjugate
some bacterial vaccines (e.g. Hib, meningococcal and pneumococcal conjugate
vaccines) are made from the chemical linking (conjugation) of a tiny amount of
the sugar (correctly known as the polysaccharide) that makes up the cell coat of
the bacteria with a protein molecule, in order to improve the immune response to
the vaccine
Contraindication
a reason why a vaccine or drug must not be given
Corticosteroid
a drug used to reduce inflammation and other immune responses
APPENDIX 5 489
appendix 5
Adverse event following immunisation (AEFI)

an unwanted reaction following administration of a vaccine, which may or may
not be caused by the vaccine; adverse events may be at the site of injection, or
may be a general illness or a general allergic reaction
DT
a vaccine that protects against diphtheria and tetanus. The acronym DT,
using capital letters, signifies the child formulation of diphtheria and tetanuscontaining vaccine, and denotes the substantially larger amounts of diphtheria
toxoid in this formulation than in the adolescent/adult formulation.
dT
reduced antigen content formulation of diphtheria-tetanus vaccine, which
contains substantially lower concentrations of diphtheria toxoid, and
approximately half the tetanus antigen content, than the child formulation
(which is signified by using capital letters DT). This vaccine is most commonly
administered to adolescents/adults.
DTP/DTPa/DTPw
a vaccine that protects against diphtheria, tetanus and pertussis (whooping
cough). The DTP used in Australia and many other industrialised countries is
DTPa, which contains an acellular pertussis component made of refined pertussis
extracts instead of inactivated whole pertussis bacteria (DTPw). The acronym
DTPa, using capital letters, signifies child formulations of diphtheria, tetanus
and acellular pertussis-containing vaccines, and denotes the substantially larger
amounts of diphtheria toxoid and pertussis antigens in these formulations than
in the adolescent/adult formulations.
dTpa
reduced antigen content formulation of diphtheria-tetanus-acellular pertussis
vaccine, which contains substantially lower concentrations of diphtheria toxoid
and pertussis antigens, and approximately half the tetanus antigen content, than
the child formulations (which are signified by using all capital letters [DTPa]).
This vaccine is most commonly administered to adolescents/adults.
Effectiveness
the extent to which a vaccine produces a benefit in a defined population in
uncontrolled or routine circumstances
Efficacy
the extent to which a vaccine produces a benefit in a defined population in
controlled or ideal circumstances, for example, in a randomised controlled trial
Encephalitis
inflammation of the brain
Encephalopathy
a general term to describe a variety of illnesses that affect the brain, including
encephalitis
Endemic
endemic infections are present all the time in a community
Enzootic
enzootic infections are present all the time in animals of a specific geographic
area
Extensive limb swelling

swelling of the limb, with or without redness, which:
extends from the joint above to the joint below the injection site, or beyond
a joint (above or below the injection site), or
results in the circumference of the limb being twice the normal size.
Febrile
related to a fever, as in febrile illness and febrile convulsions
Hepatitis
an inflammation of the liver; can be caused by viral infections
Hypotonic-hyporesponsive episode (shock, collapse)
the sudden onset of pallor or cyanosis, limpness (muscle hypotonia), and
reduced responsiveness or unresponsiveness occurring after vaccination,
where no other cause is evident, such as a vasovagal episode or anaphylaxis.
The episode usually occurs 1 to 48 hours after vaccination and resolves
spontaneously.
Immunisation
the process of inducing immunity to an infectious agent by administering a
vaccine
Immunity
the ability of the body to fight off certain infections; immunity can result from
natural (wild) infections or from vaccination
Immunogenicity
the ability (or the degree) to which a particular substance, in this context a
vaccine, may provoke an immune response
Immunoglobulin
a protein extract from blood, sometimes called antibody, that fights off infection;
injection of immunoglobulins provides temporary immunity against certain
infections
APPENDIX 5 491
APPENDIX 5
Epidemic
epidemic infections are those that spread rapidly in a community; measles and
influenza viruses are common causes of epidemics in Australia; small epidemics
are often called outbreaks
Incubation period
after a person is infected with bacteria or viruses, it often takes days or weeks
for the infection to cause an obvious illness; the time between exposure to the
infectious agent and development of the disease is called the incubation period
Infection
an infection occurs when bacteria or viruses invade the body; if the body cannot
fight the infection, it may cause an illness
Intradermal (ID) injection
an injection into the surface layers of the skin; this is used for the administration
of bacille Calmette-Gurin (BCG), the tuberculosis vaccine
an injection into the muscle; vaccines are usually injected into a muscle of the
upper outer thigh, or a muscle in the upper arm
Intussusception
when one portion of the bowel telescopes into the next portion of bowel,
resulting in a blockage
Invasive disease
this term is often used when talking about pneumococcal or meningococcal
disease. This term means that the bacteria (or germs) have been found in the
blood, spinal fluid or another part of the body that would normally be sterile (or
germ free).
Jaundice
yellow skin colour that may result from severe hepatitis
Pandemic influenza
a global epidemic that results when a new strain of influenza virus appears in the
human population. It causes more severe disease in the population because there
is little immunity to this new strain.
Paracetamol
a medicine that helps reduce fever; it may be given to minimise fevers following
vaccination
Pertussis
whooping cough, an illness caused by a bacterium, Bordetella pertussis
Polysaccharide
a group of complex carbohydrates (sugars), which make up the cell coating
present in some bacteria
Polyvalent vaccine
a combination vaccine that protects against more than one disease; examples are
DTPa and MMR
Rubella
a viral illness, sometimes also known as German measles
Seizure
a witnessed sudden loss of consciousness and generalised, tonic, clonic, tonic
clonic, or atonic motor manifestations.
Types of seizures include:
febrile seizures; with fever >38.5C
afebrile seizures; without fever
syncopal seizures; a syncope/vasovagal episode followed by seizure(s).
an injection into the tissue between the skin and the underlying muscle
Syncope
see vasovagal episode
Thrombocytopenia
platelet count <50 x 109/L
Transverse myelitis
a brief but intense attack of inflammation (swelling) in the spinal cord that
damages myelin
Vaccination
the administration of a vaccine; if vaccination is successful, it results in immunity
Vaccine
a product often made from extracts of killed viruses or bacteria, or from live
weakened strains of viruses or bacteria; the vaccine is capable of stimulating an
immune response that protects against natural (wild) infection
Varicella
chickenpox, an infection caused by the varicella-zoster virus
Vasovagal episode (syncope, faint)
episode of pallor and unresponsiveness or reduced responsiveness or feeling
light-headed AND occurring while vaccine is being administered or shortly after
(usually within 5 minutes) AND bradycardia AND resolution of symptoms with
a change in position (supine position or head between knees or limbs elevated)
APPENDIX 5 493
appendix 5
Rotavirus
a virus that is a common cause of diarrhoea (and often vomiting as well) in
young children. The diarrhoea can be severe in very young children, such that
they may need intravenous fluids (i.e. through a vein in the arm) in hospital.
Virus
a tiny living organism, smaller than a bacterium, that can cause infections;
measles, rubella, mumps, polio, influenza and hepatitis B are examples of viruses
Zoster
an abbreviation for herpes zoster infection (also known as shingles); a painful
rash and illness, caused by the varicella-zoster (chickenpox) virus
APPENDIX 6: COMMONLY USED ABBREVIATIONS
dT
DTPa
dTpa
DTPw
EIA
ELISA
FHA
FIM
GBS
GP
GVHD
HAV
HBcAg
HBeAg
Australian bat lyssavirus

Adverse Drug Reactions System
adverse event following immunisation
acquired immunodeficiency syndrome
antibody to hepatitis B e antigen
antibody to hepatitis B core antigen
antibody to hepatitis B surface antigen
acute otitis media
Australasian Society of Clinical Immunology and Allergy
Australian Technical Advisory Group on Immunisation
bacille Calmette-Gurin
cell culture infectious dose 50%
Communicable Diseases Network Australia
confidence interval
cervical intraepithelial neoplasia
congenital rubella syndrome
cerebrospinal fluid
deoxyribonucleic acid
diphtheria-tetanus vaccine for use in children (for further
explanation of this term, see Appendix 5 Glossary of technical terms)
diphtheria-tetanus vaccine for use in adults (for further
diphtheria-tetanus-acellular pertussis vaccine (for further
diphtheria-tetanus-acellular pertussis vaccine, reduced antigen
content formulation (for further explanation of this term, see
Appendix 5 Glossary of technical terms)
diphtheria-tetanus-whole-cell pertussis vaccine (for further
enzyme immunoassay
enzyme-linked immunosorbent assay
filamentous haemagglutinin
fimbriae (pertussis)
Guillain-Barr syndrome
general practitioner
graft-versus-host disease
hepatitis A virus
hepatitis B core antigen
hepatitis B e antigen
APPENDIX 6 495
appendix 6
ABLV
ACIR
ACT
ADRS
AEFI
AIDS
anti-HBe
anti-HBc
anti-HBs
AOM
ASCIA
ATAGI
BCG
CCID50
CDNA
CI
CIN
CRS
CSF
DNA
DT
HBIG
hepatitis B immunoglobulin
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCW
healthcare worker
HDCV
human diploid cell vaccine (rabies)
HepA
hepatitis A vaccine
HepB
hepatitis B vaccine
HHE
hypotonic-hyporesponsive episode
Hib
Hib-MenCCV Haemophilus influenzae type b-meningococcal C conjugate vaccine
HIV
human immunodeficiency virus
HPV
human papillomavirus
2vHPV
bivalent HPV vaccine
4vHPV
quadrivalent HPV vaccine
HRIG
human rabies immunoglobulin
HSCT
haematopoietic stem cell transplant
HZ
herpes zoster
ID intradermal
IgA/G/M
immunoglobulin A/G/M
IM intramuscular
IPD
invasive pneumococcal disease
IPV
IS intussusception
ITP
idiopathic thrombocytopenia purpura
IU
international units
IV intravenous
JE
LT-ETEC
heat-labile toxin producing enterotoxigenic Escherichia coli
MenCCV
meningococcal serogroup C conjugate vaccine
4vMenCV
quadrivalent meningococcal conjugate vaccine
4vMenPV
quadrivalent meningococcal polysaccharide vaccine
MMR measles-mumps-rubella
MMRV measles-mumps-rubella-varicella
NCIRS
National Centre for Immunisation Research and Surveillance of
Vaccine Preventable Diseases
NHIG
normal human immunoglobulin
NHMRC
National Health and Medical Research Council
NHVPR
National HPV Vaccination Program Register
NIP
National Immunisation Program
NSW
New South Wales
NT
Northern Territory
NTHi non-typeable Haemophilus influenzae
OMP
outer membrane protein
APPENDIX 6 497
appendix 6
OPV
oral poliomyelitis vaccine
PCECV
purified chick embryo cell vaccine (rabies)
PCR
polymerase chain reaction
7vPCV
10vPCV
13vPCV
PEP
post-exposure prophylaxis
pH1N1
pandemic influenza A(H1N1)pdm09
PHN
post-herpetic neuralgia
PI
product information
PreP
pre-exposure prophylaxis
23vPPV
23-valent pneumococcal polysaccharide vaccine
PRN pertactin
PRP
polyribosylribitol phosphate
PRP-OMP
PRP conjugated to the outer membrane protein of Neisseria
meningitidis
PRP-T
PRP conjugated to tetanus toxoid
PT
pertussis toxoid
Qld Queensland
RCT
randomised controlled trial
RIG
RNA
ribonucleic acid
SA
South Australia
SC subcutaneous
SCID
severe combined immunodeficiency
SIDS
sudden infant death syndrome
SOT
solid organ transplant
SSPE
subacute sclerosing panencephalitis
Tas Tasmania
TB tuberculosis
TCID50
tissue culture infectious dose 50%
TGA
Therapeutic Goods Administration
TIG
tetanus immunoglobulin
TST
tuberculin skin test
Vic Victoria
VLP
virus-like particle
VNAb
(rabies) virus neutralising antibody
VPD
vaccine-preventable disease
VV
varicella vaccine
VZV
varicella-zoster virus
WA
Western Australia
WHO
World Health Organization
ZIG
zoster immunoglobulin
APPENDIX 7: OVERVIEW OF VACCINE AVAILABILITY

IN AUSTRALIA
Table A7.1 provides an overview of key dates when vaccines first came into
widespread use in Australia. This table provides only some dates; for specific
details on vaccine registration, funding, recommendations and program use,
please see complete information in the NCIRS Vaccination History Tables
available from the NCIRS website (www.ncirs.edu.au/immunisation/history/
index.php). These tables, listed by vaccine type, provide a summary of the
significant events in vaccination practice in Australia, particularly for vaccines
used in population-based immunisation programs. Additional information
regarding vaccines available in each jurisdiction can also be sought from your
local state or territory Immunisation Department.
Table A7.1: Key dates when vaccines first came into widespread use in Australia
Year
Vaccine
1945
Tetanus toxoid
1953
Diphtheria-tetanus-pertussis, whole-cell (DTPw)
1956
Poliomyelitis (Salk) (inactivated poliomyelitis vaccine [IPV])
1966
Poliomyelitis (Sabin) (live attenuated oral poliomyelitis vaccine [OPV])
1970
Measles
1971
Rubella
1975
Child diphtheria-tetanus (CDT)
1982
Adult diphtheria-tetanus (ADT)
1982
Measles-mumps
1982
Hepatitis B (hepB) (serum-derived vaccine)
1987
Hepatitis B (recombinant vaccine)
1989
1993
1994
Hepatitis A
1997
Diphtheria-tetanus-pertussis, acellular (DTPa)
1999
Influenza
1999
23-valent pneumococcal polysaccharide (23vPPV)
2000
DTPa-hepB
2000
Hib(PRP-OMP)-hepB
2001
7-valent pneumococcal conjugate (7vPCV)
Vaccine
2003
Varicella
2003
Meningococcal C conjugate
2004
Diphtheria-tetanus-pertussis, acellular; reduced antigen content

formulations (dTpa and dTpa-IPV)
2005
Pentavalent and hexavalent combination DTPa vaccines (DTPa-hepB-IPVHib; DTPa-IPV; DTPa-hepB-IPV; DTPa-IPV-Hib)
2007
2007
Rotavirus
2009
2011
2013
APPENDIX 7 499
Appendix 7
Year
INDEX
catch-up vaccination schedules for those

10 years of age, 6364
minimum acceptable vaccine dose
intervals, 50
number of vaccine doses for children, 49
pneumococcal disease epidemiology,
318319
route of vaccine administration, 6869
vaccination recommendations, 324333
Italicised numbers indicate tables

2-phenoxyethanol, in vaccines, 19, 484
7vPCV (7-valent pneumococcal conjugate
vaccine), 45, 5660, 108, 194, 320, 321, 322,
328, 333
adverse events following immunisation
(AEFI), 335
pneumococcal disease epidemiology,
318319
vaccine), 8, 14, 43, 46, 5253, 56, 58, 60, 68,
194, 319, 320. see also pneumococcal disease
(AEFI), 335
dosage and administration, 323324
and Indigenous children, 108
pregnancy and breastfeeding, 334
transport, storage and handling, 323
vaccine), 8, 1415, 43, 46, 62, 68, 105, 149, 151,
156, 160, 160161, 163164, 174, 194, 251, 257,
319322
(AEFI), 334335
catch-up vaccination, 5253, 5758
catch-up vaccination guidelines for
children with medical condition
associated with an increased risk, 5960
children without medical condition
and influenza vaccination, 257
intervals, 50
precautions, 334
pregnancy and breastfeeding, 136, 334
variations from product information,
336337
23vPPV (23-valent pneumococcal
polysaccharide vaccine), 15, 62, 105, 110, 137,
143, 149, 151, 156, 160, 161, 163, 163164, 321,
321322, 455, 471
(AEFI), 336
children with medical condition
abattoir workers. see animals, persons working

with
abbreviations list, 495497
Aboriginal and Torres Strait Islander people,
35, 104112
additional recommended vaccines, 105
adults, 109111
catch-up vaccination, 5758
changes to recommendations in the 10th
edition of the handbook, 9, 12, 15
children, 49, 50, 106108
Haemophilus influenzae type b (Hib),
106107, 192
hepatitis A, 47, 107, 198199, 201, 203, 206
hepatitis B, 109, 209, 221
human papillomavirus (HPV), 233
influenza, 108, 109110, 246, 254
Japanese encephalitis, 111
pneumococcal disease, 5253, 108, 110111,
133, 318319, 321, 324325, 327328, 329,
330332
rotavirus, 373
rubella, 111, 390
service delivery to, 112
tuberculosis, 106, 408, 412
Act-HIB, 51, 55, 192
variations from product information, 197
active immunisation, 1820
acute febrile illness, vaccination
recommendations, 31
acute otitis media (AOM). see otitis media
acute systemic illness, vaccination
recommendations, 31
Adacel, 123, 185, 306, 400
vaccine components, 470471
variations from product information, 189,
315, 406407
Adacel Polio, 185, 189, 306, 315, 340, 344, 400
additives, in vaccines, 485486
adjuvants, in vaccines, 19, 484485
administration of vaccines, 6584
changes in the 10th edition of the
handbook, 9
equipment, 6569
tetanus, 400, 402, 403404

vaccination status and history, 40
varicella vaccination, 425, 429
and varicella vaccination, 434
yellow fever vaccination, 444
and zoster, 446447, 447448
zoster vaccination, 450453
adverse events following immunisation (AEFI),
9, 18, 2123, 8597, 481482
anaphylaxis and vasovagal episodes, 8791
cholera, 181
common events, 91
diphtheria, 187188
events without causal link, 94
Haemophilus influenzae type b (Hib), 196
hepatitis A, 207
hepatitis B, 227228
human papillomavirus (HPV), 240, 241242
influenza, 249, 257258
measles, 278280
meningococcal disease, 292
mumps, 301
mumps vaccination, 301
passive immunisation, 458, 464
pertussis, 311, 312313
pneumococcal disease, 335336
poliomyelitis, 343
poliomyelitis vaccination, 343
Q fever, 351352
rabies and other lyssaviruses (including
Australian bat lyssavirus), 370371
reporting of, 9497
rotavirus, 381382
rubella, 394
state and territory contact information, 96
tetanus, 405
tuberculosis (TB), 414
typhoid, 422
uncommon or rare events, 9293
vaccination of persons who have had an
AEFI, 130133
varicella, 433435
yellow fever, 443, 444445
zoster (herpes zoster), 448, 454
Aedes aegypti, 439. see also yellow fever
Africa
cholera, 176
hepatitis B, 118, 209, 221
influenza, 245
measles, 268, 269
meningococcal disease, 120, 284
migrants to Australia from, 174
poliomyelitis, 338
Australian bat lyssavirus), 354, 361
rubella, 390
INDEX 501
Index
identifying the injection site, 7982

injection techniques, 7173
multiple vaccine injections, 8384
occupational health and safety issues, 65
positioning, 7578
preparation, 70
recommended injection sites, 7374
route, 6769
adolescents
catch-up vaccination schedules, 6162,
6364
diphtheria, 186
hepatitis B, 213, 214, 214215, 220
injection sites, 74
measles, post-exposure prophylaxis, 281
measles, vaccination, 273
mumps, 299300
pertussis, 306
positioning for vaccination, 78
Q fever, 348350
rabies, 356357
rubella, 389390
tetanus, 400, 401
varicella, 425, 428429, 429
adrenaline
autoinjectors, 9091
doses, 90
in management of anaphylaxis, 8991
ADT Booster, 123, 184, 400
406
adults
catch-up vaccination schedules, 6164,
6364
cholera, 179
consent on behalf of an adult lacking
capacity, 27
diphtheria, 186187
hepatitis A, 202
hepatitis B, 213214, 214215, 220224
Indigenous persons, 109111
influenza, 251
injection sites, 74
mumps, 299300
pneumococcal disease, 326327, 330333
poliomyelitis, 342
positioning for vaccination, 78
Q fever, 348350
rabies, 356357
rubella, 389390
travel to, 116

tuberculosis, 408
typhoid, 416, 418
yellow fever, 114, 439440, 443
agammaglobulinaemia, vaccination
recommendations, 166
aged care facility residents, and influenza
vaccination, 255
agricultural staff and students, vaccination
Agrippal, 247, 470472
AIDS, and zoster vaccination, 450451
albumin, in vaccines, 469
alcoholism, 13
and pneumococcal disease, 327
and tuberculosis (TB), 408
allergies, 32, 131133, 480481. see also egg
allergies
aluminium hydroxide, in vaccines, 19, 469470,
484485
aluminium phosphate, in vaccines, 470,
484485
Americas
cholera, 176
hepatitis B, 118, 209
poliomyelitis, 338
rubella, 390
tuberculosis, 409
yellow fever, 114, 116, 439, 440
anaesthesia, vaccination recommendations
before or after, 168
anal cancer, 233
anaphylaxis, 37, 43, 8791, 9293, 131132
adrenaline use, 8991
and cholera vaccination, 180
clinical features, 88
contraindications to vaccination, 37
and diphtheria vaccination, 187, 190
and Haemophilus influenzae type b (Hib)
vaccination, 196, 197
and hepatitis A vaccination, 206
and hepatitis B vaccination, 227, 230
and human papillomavirus vaccination,
241242
and immunoglobulin injection, 464
an influenza vaccination, 256257, 258
and Japanese encephalitis vaccination, 265
and measles vaccination, 275, 279
and meningococcal vaccination, 292
and pertussis vaccination, 312
and pneumococcal vaccination, 334
and poliomyelitis vaccination, 343
response kit, 24
and rotavirus vaccination, 379

and rubella vaccination, 392
and tetanus vaccination, 404, 405
and tuberculosis vaccination, 414
and typhoid vaccination, 421
and yellow fever vaccination, 443, 444
and zoster vaccination, 453
animals, persons working with
influenza vaccination, 255
Q fever vaccination, 346, 348
anogenital warts, 233234
anterolateral thigh injection site, 7980
antibiotics, and typhoid vaccination, 421
antiviral medication, and zoster vaccination,
454
armed forces
hepatitis B, 223
typhoid, 420
Asia
cholera, 176
diphtheria, 187
hepatitis B, 118, 209, 221
influenza, 245
Japanese encephalitis, 113114, 119,
259260, 263264
measles, 268, 269, 487
poliomyelitis, 338
rubella, 390
tick-borne encephalitis, 121
tuberculosis, 408
typhoid, 122, 416
yellow fever, 439
aspirin therapy
and measles vaccination, 278
and varicella vaccination, 433, 438
asplenia, persons with, 10
vaccination, 195196, 197
meningococcal vaccination, 52, 136, 137,
153, 283, 290, 291, 294
and pneumococcal disease, 317, 326327,
332
vaccination recommendations, 35, 62,
161164, 163164
Australian bat lyssavirus (ABLV), 353, 354. see
also rabies and other lyssaviruses (including
Australian bat lyssavirus)
BabyBIG, 461
bacille Calmette-Gurin vaccine. see BCG
vaccine
bats. see animals, persons working with
BCG (bacille Calmette-Gurin vaccine) vaccine,
16, 37, 67, 409410
(AEFI), 414
and HIV-infected persons, 159
and immunocompromised persons,
147148
for Indigenous neonates, 104, 105, 106
precautions, 414
and pregnancy, 139, 142, 413
recipients of, further vaccination
recommendations, 32
route of vaccine administration, 6869, 72
and subsequent live vaccines, 33, 271, 276,
298, 300, 376, 388, 393
and travellers, 121
vaccination procedures, 411
bleeding disorders, vaccination

recommendations, 35, 168
blood product recipients, 33, 166167
hepatitis B, 222223
measles, 276277
rotavirus, 381
rubella, 393394
varicella, 432433
zoster, 454
body-piercers. see skin penetration procedures
bone marrow malignancies, and tuberculosis
vaccination, 413
Boostrix, 185, 306, 400
doses and route of administration, 123
190, 315316, 406407
Boostrix-IPV, 185, 307, 341, 400
doses and route of administration, 123
190, 315316, 344, 407
borax, in vaccines, 470
Bordetella parapertussis, 302. see also pertussis
Bordetella pertussis, 302, 398. see also pertussis
botulism antitoxin, 461
availability, 457
brachial neuritis, 93, 489
and diphtheria vaccination, 187188
and tetanus vaccination, 405
breast cancer patients, injection sites, 74
breastfeeding
vaccination, 196
and human papillomavirus (HPV)
vaccination, 240
and Japanese encephalitis vaccination,
264265
and mumps vaccination, 300
and Q fever vaccination, 350351
and rabies vaccination, 370
and yellow fever vaccination, 443
INDEX 503
Index

(AEFI) notification, 95, 96
age of consent, 26
Australian Red Cross Blood Service, 457
government health authority and
communicable disease control contact
details, 465466
pneumococcal vaccination, 52, 56
(ACIR), 39, 8999, 174, 268, 465
Australian Government Department of Health,
4, 22, 122, 129, 442, 465, 488
Australian Government Department of
Immigration and Citizenship (DIAC),
information about refugee immunisation, 173
Australian Influenza Vaccine Committee, 248
Australian Q Fever Register, 102, 349
Australian Technical Advisory Group on
Immunisation, xixii, 1, 3
autism, 94, 280, 483
autoimmune conditions, vaccination
Avaxim, 199
lower age limits for, 127
recommended doses and schedules, 125,
202
cancer patients. see oncology patients

cardiac disease
carers
measles vaccination, 274
for 13vPCV and 23vPPV in children with a
medical condition(s) associated with an
increased risk of invasive pneumococcal
disease, 5960
for 13vPCV in Indigenous children in NT,
Qld, SA or WA, 5758
for 13vPCV in non-Indigenous children,
and Indigenous children in the ACT,
NSW, Tas and Vic, who do not have any
medical condition(s) associated with an
increased risk of invasive pneumococcal
disease, 56
children <10 years of age, 4360
confirmation of vaccination history, 3940
determining a valid dose, 41
for Hib in children <5 years of age, 5455
minimum acceptable age for the 1st dose,
4648
minimum acceptable age for the 1st dose of
scheduled vaccines in infants in special
circumstances, 4648
minimum acceptable dose intervals for
children <10 years of age, 50
number of vaccine doses that should have
been administered by the current age, 49
persons >10 years of age, 6164
planning of, 4143
serological testing as a guide to, 41
worksheet for children <10 years of age,
4648
cellulitis. see Haemophilus influenzae type b (Hib)
cerebrospinal fluid (CSF) leak, and
Cervarix, 234
cervical cancer, 231, 232233
cervical intraepithelial neoplasia (CIN), 231
cervical screening, 239240
chemotherapy, persons receiving. see
immunosuppressive therapy
chickenpox. see varicella
child counselling services workers, vaccination
childcare workers. see early childhood
education and care workers
children, 419420
catch-up vaccination guidelines, 5160

catch-up vaccination schedule for 13vPCV
vaccine, 56, 5758, 5960
catch-up vaccination schedule for 23vPCV
vaccine, 5960
catch-up vaccination schedule for
10 years of age, 6164, 6364
catch-up worksheet, 4344, 45
cholera, 179
consent, 2627
diphtheria, 186
hepatitis A, 202
hepatitis B, 212213, 214215, 218220
human papillomavirus, 238
Indigenous children, 106108
influenza, 247248, 251, 254, 257
injection sites, 7374
minimum acceptable age for the 1st vaccine
dose, 4648
intervals, 50
mumps, 299
number of vaccine doses by age, 49
poliomyelitis, 342
positioning for vaccination, 7778, 78
Q fever, 348
rabies, 356357, 388389
tetanus, 398400, 401
tuberculosis, 410, 412
varicella, 425, 427428, 429, 434
yellow fever, 441
zoster, 435
Chlamydia pneumoniae, 302. see also pertussis
cholera, 176181
adverse events, 181
bacteriology, 176
handbook, 11
contraindications, 180
epidemiology, 176177
precautions, 180
public health management, 181
congenital varicella syndrome, 423

consent, 2528
on behalf of a child or adolescent, 2627
on behalf of an adult lacking capacity, 27
evidence of, 2728
for school-based vaccination programs, 28
contraindications to vaccination, 37. see also
under individual disease names
commonly asked questions about, 477481
false contraindications, 37, 38
convulsions, persons with family history, and
correctional facility inmates, 174
hepatitis A, 204, 205
hepatitis B, 216, 223, 224
influenza, 255
correctional facility staff
measles, 274
corticosteroid administration, 478. see also
and live attenuated vaccines, 146
and rabies post-exposure prophylaxis, 362
Coxiella burnetii, 345, 347. see also Q fever
cuddle position, 75, 77
cytomegalovirus immunoglobulin, 461
availability, 457
day-care workers. see early childhood

deltoid injection site, 8182
detention centre staff, vaccination
developmental disability, persons with
hepatitis A vaccination, 204
hepatitis B vaccination, 223
diabetes, type 1, vaccination recommendations,
165
diabetes mellitus
diphtheria, 182190
(AEFI), 187188
bacteriology, 182
handbook, 1112
INDEX 505
Index
and travellers, 119

vaccines, 177178
chronic cardiac disease, and pneumococcal
disease, 327
chronic conditions, vaccination
recommendations, 35, 165
chronic inherited metabolic diseases, and
chronic liver disease patients
hepatitis A, 204
hepatitis B, 222
chronic lung disease, and pneumococcal
disease, 327
chronic neurological conditions, and influenza
vaccination, 253
chronic renal failure, and influenza vaccination,
254
chronic respiratory conditions, and influenza
vaccination, 253
Clostridium tetani, 51, 397, 405, 463. see also
tetanus
CMV Immunoglobulin-VF (human), 461
co-administration of vaccines, 8. see also
simultaneous injections
cholera, 179
Haemophilus influenzae type b (Hib), 194, 203
hepatitis A, 203
influenza, 92, 251
measles, 271
MMR (measles-mumps-rubella) vaccines,
271, 301
MMRV (measles-mumps-rubella-varicella)
vaccines, 271, 301
mumps, 298
rotavirus, 376
rubella, 388
typhoid, 419
varicella, 427
yellow fever, 441
cochlear implants, and pneumococcal disease,
326
cold chain, 25
complement component disorders, and
meningococcal vaccination, 291
congenital cellular immunodeficiencies, and
tuberculosis vaccination, 413
congenital limb malformation, injection sites,
74
congenital rubella syndrome (CRS), 384
epidemiology, 182
and travellers, 117
vaccines, 183185
188190
diphtheria antitoxin, 463
diphtheria-tetanus (dT) vaccine, 184, 400, 490
(AEFI), 405
10 years of age, 63
vaccination recommendations, 401402,
403404
diphtheria-tetanus-acellular pertussis (dTpa
and DTPa) vaccines, 183, 303, 304307,
398400, 490
(AEFI), 312313
catch-up vaccination for children, 46, 50, 51
10 years of age, 63
dose, 46
intervals, 50
and pregnancy, 135, 310311
401, 403404
diphtheria-tetanus-whole-cell pertussis
(DTPw) vaccine, 303, 490
(AEFI), 312
diseases. see vaccine-preventable diseases
distraction technique, 70
documentation of vaccination, 97
when incomplete, 40
dosage. see also under individual disease names,
valid dose determination, 41
dose intervals, minimum. see minimum
acceptable dose intervals for children
Down syndrome, 8
and influenza vaccination, 13, 252
drugs, persons who inject, 36, 61
hepatitis A, 198, 204, 205
hepatitis B, 209, 210, 216, 222, 224, 225
tetanus, 403
dT vaccines. see diphtheria-tetanus vaccine

(dT) vaccines
DTPa-containing vaccine. see diphtheriatetanus-acellular pertussis (dTpa and DTPa)
vaccines
dTpa-containing vaccines. see diphtheriatetanus-acellular pertussis (dTpa and DTPa)
vaccines
Dukoral, 177
early childhood education and care workers

influenza, 255
measles, 274
pertussis, 310
vaccination recommendations, 169, 170
varicella, 430
eculizumab treatment, and meningococcal
vaccination, 291
effectiveness of vaccines, 2021
efficacy of vaccines, 2021
egg allergies, 10, 131, 132133, 481
and influenza vaccination, 132, 256257, 258
egg protein, in vaccines, 19, 470, 486
embalmers
tuberculosis, 413
emergency workers
influenza, 255
Engerix-B, 160, 211, 212
dosage and administration, 123, 217
vaccination schedule, 214
vaccination schedule, accelerated, 215, 216
vaccine components, 469, 472
enteric fever. see typhoid
epiglottitis, 191
erythematous skin reactions, 351
Essen, 363
essential services personnel, influenza
vaccination, 255
Europe
diphtheria, 187
hepatitis B, 209
influenza, 245
measles, 268
mumps, 295
poliomyelitis, 338

tick-borne encephalitis, 114, 121
failure of vaccines, 2021
fainting. see vasovagal episode
fatal disseminated infection, and tuberculosis
vaccination, 414
febrile convulsions, 9293, 94
and influenza vaccination, 244, 249, 257
febrile seizures, 493
and pneumococcal vaccination, 334, 335
Fluad, 248
Fluarix, 247
Fluvax, 92, 248
(AEFI), 249, 257
Fluvax Junior, 92
(AEFI), 257
formaldehyde, in vaccines, 19, 470, 486
funeral workers, vaccination recommendations,
172
Gardasil, 234, 235

gastroenteritis, and rotavirus vaccination, 380
gelatin, in vaccines, 19, 471, 485
gentamicin, in vaccines, 471
glossary of technical terms, 489494
glutaraldehyde, in vaccines, 471
glycine, in vaccines, 485
Guillain-Barr syndrome (GBS), 93
and meningococcal vaccination, 292, 293

recipients
hepatitis B, 222
INDEX 507
Index
rotavirus, 373
156157
zoster, 447
haemodialysis patients, hepatitis B vaccination,
222
haemoglobinopathies
Haemophilus influenzae, 191, 192
(AEFI), 196
bacteriology, 191
catch-up vaccination for children, 46, 49,
50, 51, 5455
handbook, 12
co-administration with other vaccines, 203
interchangeability of vaccines, 194
dose, 46
intervals, 50
and persons with asplenia, 162, 163164
and preterm infants, 144
vaccines, 192193
Haemophilus influenzae type bmeningococcal C
combination vaccine (Hib-MenCCV), 12, 14,
52, 192193, 285286, 288. see also Haemophilus
influenzae type b (Hib); meningococcal
disease
Hajj pilgrimage, 116, 120, 129, 290. see also
Middle East
HALO principle, 6163
Havrix 1440, 199
Havrix Junior, 199
recommended dose and schedule, 202
recommended lower age limit, 127
HBsAg-positive mothers, hepatitis B
vaccination, 219
H-B-Vax II, 212, 217

dosage and administration, 123, 211, 222
vaccination schedule, 156, 214
healthcare workers
hepatitis B, 228
influenza, 255
measles, 274
pertussis, 310
poliomyelitis, 342
rubella, 389390
tuberculosis, 413
varicella, 430
hepatitis A
(AEFI), 207
handbook, 12
and Indigenous persons, 107, 203
dose, 47
intervals, 50
serological testing for immunity, 206
and travellers, 119
vaccines, 199201
virology, 198
hepatitis A/hepatitis B combination vaccines,
205, 217, 224
hepatitis A/typhoid combination vaccines,
205206
hepatitis B, 208230
(AEFI), 227228
booster doses, 224225
children, 51
handbook, 12
combination vaccines, 224

hepatitis B immunoglobulin (HBIG), 219
higher risk groups, 220224
dose, 46
intervals, 50
non-responders to vaccination, 226
and travellers, 117118
vaccination schedules, 214215
vaccination schedules, accelerated, 215216
virology, 208
hepatitis B immunoglobulin (HBIG), 229, 460
availability, 457
and HBsAg-positive mothers, 219
Hepatitis B Immunoglobulin-VF, 229
hepatitis C patients, hepatitis B vaccination,
222
herpes zoster (HZ), 423. see also zoster (herpes
zoster)
Hiberix, 51, 193
Hirschsprungs disease, and rotavirus
vaccination, 380
history of vaccination. see vaccination status
and history
HIV-infected persons. see also
categories of immunocompromise, 158
measles, 277
rubella, 392
tuberculosis, 413
typhoid, 421
varicella, 431
yellow fever, 444
zoster, 447, 450451, 454
homeless people, influenza vaccination, 255
homosexuals. see men who have sex with men
HPV Register. see National HPV Vaccination
Program Register (NHVPR)
immigrants. see migrants to Australia

immunisation, commonly asked questions,
487488
active, 1820
passive, 17, 18, 456464
immunisation handbook
background, 12
development, 34
fundamentals of immunisation, 1823
how to use, 56
literature search strategy, 467468
whats new, 717
Immunisation History Statements, 99100
immunisation registers, 8597
immunocompromised persons. see also
immunocompromising conditions
hepatitis B, 222
influenza, 253254
measles, 275276, 277
rotavirus, 373, 379, 380381

rubella, 392
typhoid, 421
vaccination recommendations for
household members of, 36, 148
varicella, 430, 431
yellow fever, 444
zoster, 435436, 447, 450, 451452, 453
immunocompromising conditions. see
also immunocompromised persons;
asplenia, 161164
recipients, 161164
HIV-infected persons, 158160
persons with autoimmune and other
chronic conditions, 165
solid organ transplant (SOT) recipients,
150154
immunoglobulin administration, and zoster
vaccination, 454
immunoglobulin recipients. see normal human
immunoglobulin (NHIG) recipients
immunoglobulin treatment. see normal human
immunoglobulin (NHIG) treatment
immunoglobulins, 456464
adverse events, 464
availability, 457
contraindications to use, 464
for intramuscular use, 457459
normal human immunoglobulins (NHIG),
456
specific immunoglobulins, 456457,
459463
and rabies post-exposure prophylaxis, 362
and zoster immunoglobulin, 435436, 461
Imogam Rabies Pasteurized, 355
Imojev, 37, 111, 260261
(AEFI), 265266
booster doses, 264
impaired immunity. see immunocompromising
conditions
impaired immunity, persons with. see
INDEX 509
Index
HPV Vaccination Program, 234

human diploid cell vaccine (HDCV), 68, 133,
355, 356, 358, 359, 363, 365, 370
human papillomavirus (HPV)
(AEFI), 241242
catch-up vaccination schedules, 6364
handbook, 13
female vaccination, 237238
male vaccination, 238239
National HPV Vaccination Program
Register (NHVPR), 101102
vaccines, 234236
virology, 231
human rabies immunoglobulin, 357, 362363
and post-exposure prophylaxis, 360368
and pregnancy and breastfeeding, 370
hypopituitarism, vaccination
hypotonic-hyporesponsive episode (HHE), 93
inactivated poliomyelitis vaccine (IPV),

6869, 118, 138, 156, 194, 339, 341. see also
poliomyelitis
Indigenous community workers, vaccination
Indigenous persons. see Aboriginal and Torres
Strait Islander people
indurated lesions, 352
Infanrix hexa, 51, 67, 183, 193, 195, 211, 305,
339340, 342, 399
transport, storage and handling, 185, 194,
217, 307, 341, 401
190, 197, 230, 314, 316, 343, 405, 407
Infanrix IPV, 184, 305, 340, 342, 399
190, 314, 316, 343344, 406, 407
infants
cholera, 186
diphtheria, 186
hepatitis B, 212, 214215, 218220, 219
influenza, 251
injection sites, 73
mumps, 299
pertussis, 307308, 309310
poliomyelitis, 342
positioning for vaccination, 7576, 77
rabies, 356357
rotavirus, 377378, 380381
rubella, 388
tetanus, 401
vaccination recommendations for parents,
grandparents and carers, 36, 309
zoster immunoglobulin, 435436
influenza
(AEFI), 257258
handbook, 13
and egg allergies, 256257

and immunocompromised persons, 145
and Indigenous persons, 108, 109110, 254
national notification and hospitalisation
rates, 245
precautions, 256257
and travellers, 118
vaccination and egg allergies, 132
vaccines, 246250
virology, 243
influenza pandemic, 245246
Influvac, 247
Influvac Junior, 247
injecting drug users. see drugs, persons who
inject
injection of vaccines, 6667
injection site abscess
injection site nodules, 91
injection site reactions, 63, 74
vaccination, 241
265266
and zoster vaccination, 448, 451, 452, 454
injection sites
adolescents, 74
adults, 74
breast cancer or lymphoedema patients, 74
children, 7374
children in spica casts, 74
children with congenital limb
malformation, 74
identification of, 7982
infants, 73
multiple injections, 8384
injection techniques
intradermal injection, 72
intramuscular injection, 7173
subcutaneous injection, 72
inmates of correctional facilities. see
correctional facility inmates
Intanza 9 mg, 68, 72, 248, 249
Intanza 15 mg, 68, 72, 248, 249
(AEFI), 265266
handbook, 13
and Indigenous persons, 111
precautions, 265
pregnancy and breastfeeding, 138, 140,
264265
and travellers, 119
vaccines, 260262
virology, 259
JEspect, 68, 111, 260, 261262
(AEFI), 266
precautions, 265
kanamycin, in vaccines, 471

keloid formation, and tuberculosis vaccination,
411, 414
laboratory personnel
poliomyelitis, 342
lactose, in vaccines, 19, 485
leprosy, and tuberculosis vaccination, 412
leukaemia. see immunocompromised persons
lifestyle vaccination requirements, 36
limb swelling, and pertussis vaccination, 308,
312, 491
Liquid PedvaxHIB, 51, 55, 193
live attenuated vaccines, 32, 37. see also
Japanese encephalitis; MMR (measlesmumps-rubella) vaccine; MMRV (measlesmumps-rubella-varicella) vaccine; rotavirus;
tuberculosis; typhoid; varicella; yellow fever;
zoster (herpes zoster)
and anaesthesia or surgery, 168
and autoimmune conditions, 165
and blood products, 150, 166
and corticosteroids, 165
and haematopoietic stem cell transplant
(HSCT) recipients, 155
and immunocompromised persons, 32,
3536, 142, 145, 146, 147148
and immunoglobulins, 150, 463464
and migrants to Australia, 174
and normal human immunoglobulin
(NHIG) recipients, 166
and pregnancy, 33, 34, 133134, 142
livestock workers. see animals, persons
working with
local adverse event. see injection site reactions
long-term care facility workers
influenza, 255
measles, 274
varicella, 430
lymphoedema patients, injection sites, 74
lymphoid system malignancies, and
tuberculosis vaccination, 413
lymphoma. see immunocompromised persons
Lyssavirus, 353. see also rabies and other
lyssaviruses (including Australian bat
lyssavirus)
lyssaviruses. see rabies and other lyssaviruses
(including Australian bat lyssavirus)
INDEX 511
Index
interferon-gamma release assays (IGRAs), 410

International Certificate of Vaccination or
Prophylaxis against yellow fever, 440,
441442
international travel. see travellers
interruption to a vaccination, 73, 376, 383
intracranial shunts, and pneumococcal disease,
326
intradermal injection technique, 72
intradermal vaccines, 6869
intramuscular (IM) injection technique, 71
intramuscular (IM) injection vaccines, 6869
intussusception (IS), and rotavirus vaccination,
16, 22, 93, 374375, 379, 381382
invasive pneumococcal disease (IPD). see
pneumococcal disease
IPOL, 69, 339, 341
(AEFI), 343
malabsorption syndromes, and rotavirus

vaccination, 380
malnutrition, and tuberculosis vaccination, 413
mannitol, in vaccines, 19, 471, 485
Mantoux test. see tuberculin skin test
manufacturing residuals, in vaccines, 486
measles
(AEFI), 278280
handbook, 1314
global elimination, 268
and other live attenuated parenteral
vaccines, 276
precautions, 276278
transport, storage and handling of vaccines,
270
and travellers, 118
vaccines, 269270
virology, 267
measles control campaigns, 268, 296, 384
measles-mumps-rubella vaccine. see MMR
(measles-mumps-rubella) vaccine
measles-mumps-rubella-varicella vaccine. see
vaccine
meat industry workers. see animals, persons
working with
Medicare Online, 98
men who have sex with men, 174
Menactra, 285286
(AEFI), 292
Mencevax ACWY, 287
Meningitec, 285
meningitis. see Haemophilus influenzae type b

(Hib); meningococcal disease
meningococcal C conjugate vaccines
(MenCCV), 284, 285, 289290. see also
meningococcal disease
dose, 47
(AEFI), 292
bacteriology, 283
children, 52
handbook, 14
epidemiology, 284
and haematopoietic stem cell transplant
(HSCT) recipients, 157
intervals, 50
and persons with asplenia, 161162,
163164
and solid organ transplant (SOT) recipients,
153
and travellers, 120
vaccines, 69, 285287
variations from vaccine product
information, 293294
Menitorix, 51, 52, 55, 193, 285
transport, storage and handling, 194, 288
Menjugate Syringe, 285
Menomune, 287
Menveo, 286
vaccination of suspected rubella contacts,

394395
396
M-M-R II, 68, 269, 297, 386
dosage and administration, 124, 271, 298,
387
387
vaccines, 6869, 270, 296297, 386, 424, 425,
426
and adults and adolescents, 273, 299300,
428429
(AEFI), 278280, 301, 394
children, 52
and children, 272273, 299, 428
co-administration with other vaccines,
271, 301
dosage and administration, 271, 387388,
427
precautions, 276278, 393394
pregnancy and breastfeeding, 140, 275, 300,
391392
recommended intervals between
immunoglobulins or blood products and
the vaccine, 167
vaccination of suspected rubella contacts,
394395
396, 437438
Modified Essen, 363
monosodium glutamate (MSG), in vaccines,
471, 485
Morbillivirus, 267. see also measles
multi-dose vials, 67
multiple sclerosis, vaccination
mumps, 295301
(AEFI), 301
handbook, 1314
INDEX 513
Index
mercury, in vaccines. see thiomersal, in vaccines

Mrieux Inactivated Rabies Vaccine, 133, 355.
see also human diploid cell vaccine (HDCV)
metabolic diseases
Middle East
meningococcal disease, 116, 120, 290
pilgrimage to Mecca (Hajj and Umra), 116,
120, 129, 290
migrants to Australia, 173174
from hepatitis B endemic countries, 12,
209, 221
immunisation schedules for other
countries, 39
and travel, 127
tuberculosis, 412
typhoid, 417
military personnel. see armed forces
minimum acceptable age for the 1st dose of
vaccination, 8, 41, 4648
minimum acceptable dose intervals for
children, 41, 42, 50
MMR (measles-mumps-rubella) vaccines,
269270, 296297, 386, 425
and adults and adolescents, 273
(AEFI), 278280, 301, 394
children, 52
and children, 272273, 299
271, 301
and infants, 274, 299
dose, 47
intervals, 50
pregnancy and breastfeeding, 140, 275, 300,
391392
recommended intervals between
immunoglobulins or blood products and
the vaccine, 167
vaccination and egg allergies, 132133

precautions, 300301
recommended doses and schedules,
299300
and travellers, 118
vaccines, 296
virology, 295
Mycobacterium africanum, 408. see also
tuberculosis
Mycobacterium bovis, 408, 409. see also
tuberculosis
Mycobacterium canetti, 408. see also tuberculosis
Mycobacterium leprae, 410, 412. see also
tuberculosis
Mycobacterium microti, 408. see also tuberculosis
Mycobacterium tuberculosis, 408. see also
tuberculosis
Mycoplasma pneumoniae, 302. see also
tuberculosis
National Centre for Immunisation Research

and Surveillance of Vaccine Preventable
Diseases (NCIRS), 3, 27, 467, 467468, 488,
498
National HPV Vaccination Program Register
(NHVPR), 9, 40, 101102, 174
National Immunisation Program (NIP), 2, 3,
31, 67
catch-up worksheet for children <10 years
of age, 45
hepatitis B, 117
human papillomavirus, 234
measles, 272273
meningococcal disease, 52, 120, 162, 288
mumps, 299
pertussis, 303, 308
rotavirus, 373
rubella, 389
thiomersal, in vaccines, 484
varicella, 424, 428
National Measles Control Campaign, 268, 384
National Notifiable Diseases Surveillance
System, 177, 244, 284, 346
National Q fever Management Program
(NQFMP), 346
National Tuberculosis Advisory Committee

(NTAC), 410, 415
needles, 24, 65, 66, 67. see also under individual
disease names, dosage and administration
BCG (bacille Calmette-Gurin vaccine)
vaccine, 411
human rabies immunoglobulin, 357
intramuscular injection, 7172
size, length and angle, 72
subcutaneous injection, 82
tetanus immunoglobulin, 462463
Neisseria meningitidis, 192, 283. see also
meningococcal disease
NeisVac-C, 285
neomycin, in vaccines, 19, 471, 486
neonates
hepatitis B, 208, 212, 214215, 217218,
219, 227
tuberculosis, 16, 105, 106, 410, 412, 414
zoster immunoglobulin, 435436
neurological disease, and pertussis vaccination,
313
neurotropic adverse events, and yellow fever
vaccination, 445
New South Wales
1997 hepatitis A outbreak, 198
age of consent, 26
details, 465466
Q fever notifications, 346
normal human immunoglobulin (NHIG),
457459. see also immunoglobulins
hepatitis A prevention, 458
and immune deficiency, 459
measles prevention, 459
post-exposure prophylaxis for measles,
280281
post-exposure prophylaxis for rubella,
394, 396
and varicella exposure, 433, 435436
normal human immunoglobulin (NHIG)
recipients, 166167
measles, 276277
rubella, 393394
varicella, 432433
Normal Immunoglobulin-VF (human), 458
obese persons, 72
influenza, 252
occupational health and safety issues, 65
occupational risks, 2, 11, 29, 36, 61, 62, 115,
130, 169173, 371. see also under individual
occupations
hepatitis A, 199, 204, 205
hepatitis B, 223224, 225, 460
measles, 274
pertussis, 310
Q fever, 346, 348
rubella, 396
tuberculosis, 413
varicella, 430
Oceania, 113, 118, 439. see also Pacific Islands
oncology patients, vaccination
OPV, 53, 339, 341, 376
oral live attenuated typhoid vaccine. see also
Vivotif Oral
(AEFI), 422
precautions, 421422
oral poliomyelitis vaccine. see OPV
oral vaccines, 37, 6869, 73, 123126. see also
under rotavirus, typhoid and cholera
oropharyngeal cancer, 233
otitis media, 108, 191, 244, 267, 317, 321. see also
Pacific Islands. see also Oceania

rubella, 390
tuberculosis, 408
palivizumab, 462
Papua New Guinea
Japanese encephalitis, 113114, 119, 259, 263
typhoid, 122, 416
paracetamol, 85, 91, 292
and fits, 478
measles, 278, 279
varicella, 434
paralytic polio. see poliomyelitis
parenteral Vi polysaccharide vaccines, 418. see
also typhoid, vaccines
(AEFI), 422
passive immunisation, 18, 456464. see also
immunoglobulins
availability of immunoglobulins, 457
handbook, 17
normal human immunoglobulin for
intramuscular use, 457459
potential interactions with vaccines,
463464
specific immunoglobulins, 459463
Pediacel, 51, 184, 193, 305306, 340, 399
197, 315, 344, 406
pertussis, 302316
(AEFI), 312313
bacteriology, 302
handbook, 1112
interval between vaccines, 310
and travellers, 117
vaccination of contacts of cases, 314
vaccines, 304307
INDEX 515
Index
Northern Territory
ACIR reporting, 98
(AEFI) notification, 96
age of consent, 26
details, 465466
hepatitis A, 105, 107, 199, 201, 203
HPV reporting, 101
influenza, 251
NT Immunisation Register, 103
pneumococcal disease, 15, 52, 5758, 105,
108, 110, 318, 321, 324, 329, 330
nursing home staff
influenza, 255

314316
Pharmaceutical Benefits Advisory Committee
(PBAC), 3
Pharmaceutical Benefits Scheme (PBS), 3
phenol, in vaccines, 471, 484
phenoxyethanol, in vaccines, 471, 484
pilgrims attending Hajj in Saudi Arabia, 116,
120, 129, 290
plumbers, vaccination recommendations, 172
pneumococcal conjugate vaccines (PCV). see
vaccine); 13vPCV (13-valent pneumococcal
conjugate vaccine)
(AEFI), 335336
bacteriology, 317
catch-up vaccination for children, 46, 49, 50,
5253, 5758, 5960, 63
handbook, 1415
immunocompromising conditions with
increased risk of, 326327
precautions, 334
and travellers, 118
vaccines, 319323
336337
pneumococcal polysaccharide vaccine.
see 23vPPV (23-valent pneumococcal
polysaccharide vaccine)
pneumonia. see Haemophilus influenzae type b
(Hib); pneumococcal disease
Pneumovax 23, 322, 449
catch-up schedule, 5960
police, vaccination recommendations, 171
poliomyelitis, 338344, 348350
(AEFI), 343
catch-up vaccination for children, 46, 49,

50, 53
handbook, 15
dose, 46
intervals, 50
pre-vaccination testing, 348349
and travellers, 118
343344
virology, 338
poliovirus, 338
polymyxin, in vaccines, 19, 472, 486
polysorbate, in vaccines, 19, 472, 485
pork industry workers. see animals, persons
working with
positioning for vaccination
children, 7778
infants, 7576
older children, adolescents and adults, 78
post-exposure prophylaxis
hepatitis B, 229
measles, 281
varicella, 437
post-herpetic neuralgia (PHN), 446
post-vaccination procedures
(AEFI), 8597
handbook, 9
documentation of vaccination, 97
immediate after-care, 85
immunisation registers, 98103
poultry workers. see animals, persons working
with
precautions to vaccination, 5, 22, 28, 130, 477.
see also under individual disease names
pregnancy
contact with persons who received live
vaccines, 134, 142
Prevenar 13, 320

catch-up schedule, 56, 5758, 5960
Priorix, 68, 269270, 297, 386
dosage and administration, 124, 271, 298,
387
387
Priorix-tetra, 269, 270, 297, 386387, 425426
seroresponse assessment in study, 269
387, 427
437
prisoners and staff. see correctional facility
inmates; correctional facility staff
procedures for vaccination, 24103
handbook, 89
post-vaccination, 85103
pre-vaccination, 2464
product information for vaccines. see vaccine
product information
prone position, 7576, 78
ProQuad, 68, 270, 297, 387, 425426
(AEFI), 279, 434
seroresponse assessment in study, 269
387, 427
437
public health management, 5, 8. see also under
individual disease names
purified chick embryo cell vaccine (PCECV),
69, 71, 133, 355, 356, 358, 363, 370
Q fever, 345352
(AEFI), 351352
Australian Q Fever Register, 102
bacteriology, 345
handbook, 15
INDEX 517
Index

vaccination, 196
vaccination, 240
and immunosuppressive therapy, 142
and influenza vaccination, 252, 256
264265
and measles, 267
and mumps, 295
and pertussis vaccination, 303304, 308,
309, 310311
and rabies vaccination, 370
and rubella, 384, 395396
and rubella vaccination, 385, 391392,
392393
133144, 135141
and yellow fever vaccination, 443, 445
and zoster immunoglobulin, 435436
premature infants. see preterm infants
preparation for vaccine administration, 65, 70
preparation of vaccines, 6667
pre-school workers. see early childhood
preservatives, in vaccines, 484
preterm infants, 34, 38, 143144, 475
Haemophilus influenzae type b (Hib), 51,
144, 195
hepatitis B, 51, 144, 219
influenza, 144
needle size, length and angle, 72
pneumococcal disease, 43, 53, 143144, 327
rotavirus, 144, 378379
pre-vaccination procedures, 2464
anaphylaxis response kit, 24
catch-up, 3864
handbook, 8
effective cold chain, 2425
screening, 2838
valid consent, 2528
pre-vaccination screening, 2838
checklist, 3031
responses to relevant conditions or
circumstances, 31

precautions, 351
skin test, 6869
vaccine, 347
Q fever fatigue syndrome (QFS), 345, 351
Quadracel, 184, 306, 340, 399
315, 344, 406
quadrivalent meningococcal conjugate
vaccines (4vMenCV), 14, 69, 120, 153, 157,
171, 285286. see also meningococcal disease
(AEFI), 292
293294
quadrivalent meningococcal polysaccharide
vaccines (4vMenPV), 14, 20, 68, 71, 120, 285,
287, 290291. see also meningococcal disease
(AEFI), 292
and pregnancy, 136
Queensland
ACIR reporting, 98
age of consent, 26
cholera, 176
details, 465466
hepatitis A, 105, 107, 199, 201, 203, 204
HPV reporting, 101
influenza, 251
105, 108, 110, 318, 324
Q fever, 346
Vaccine Information and Vaccine
Administration System (VIVAS), 102103
yellow fever, 439
Q-Vax, 132, 347

Q-Vax Skin Test, 347
skin test process and interpretation,
348350

(AEFI), 370
booster algorithm, 369
handbook, 1516
epidemiology, 354
exposure categories, 360
post-exposure prophylaxis, 357, 360368,
366, 367
pre-exposure prophylaxis, 356357, 359360
rabies immunoglobulin, 355356
and travellers, 120
vaccines, 355
virology, 353
rabies immunoglobulin (HRIG), 357, 457,
460. see also rabies and other lyssaviruses
(including Australian bat lyssavirus)
Rabipur Inactivated Rabies Virus Vaccine, 71,
133, 355. see also purified chick embryo cell
vaccine (PCECV)
radiation therapy, persons receiving. see
rash
zoster (herpes zoster), 446
recommendation changes in the 10th edition of
the handbook, 817
reconstitution of vaccines, 6667
refugees. see migrants to Australia
registers for immunisation, 8597
regurgitation of a vaccine, 73, 376, 383
renal impaired patients, hepatitis B vaccination,
222
respiratory papillomatosis, 234
and Indigenous persons, 111
precautions, 393394
pregnancy and breastfeeding, 391392,
392393, 395396
serological testing for immunity, 390391,
395
and travellers, 118
vaccines, 386387
virology, 384
and women of child-baring age, 390, 391
Rubivirus, 384. see also rubella
safety of vaccines, 2123

salicylate therapy. see aspirin therapy
Salmonella enterica subspecies enterica serovar
Typhi, 416. see also typhoid
Saudi Arabia. see also Middle East, pilgrimage
to Mecca (Hajj and Umra), 116, 120, 129, 290
school teachers, vaccination recommendations,
170
school-based vaccination programs, 28
screening. see pre-vaccination screening
seizures, persons with family history, and
septic arthritis, 191
septicaemia, 283. see also meningococcal disease
hepatitis A, 206
hepatitis B, 225
measles, 274275
mumps, 300
rubella, 390391, 395
varicella, 429
serum, in vaccines, 469, 486
severe combined immunodeficiency, 16, 379
severe dehydrating gastroenteritis, 372. see also
rotavirus
sex industry workers, 11, 175
hepatitis B, 223, 224, 225
shearers. see animals, persons working with
shingles. see zoster (herpes zoster)
Shingles Prevention Study, 447448
short gut syndrome, and rotavirus vaccination,
380
sickle cell disease, and pneumococcal disease,
326327
INDEX 519
Index
respiratory syncytial virus monoclonal

antibody, 457, 462
Reye syndrome, and varicella vaccination, 438
rheumatoid arthritis, vaccination
risks and benefits of vaccines, 27
Rotarix, 374375
(AEFI), 381382
RotaShield, 374375
RotaTeq, 374375
(AEFI), 381382
precautions, 380
rotavirus, 372383
(AEFI), 381382
children, 53
handbook, 16
dosage and administration, 47, 49, 50, 376
precautions, 380381
and recipients of normal human
immunoglobulin and other blood
products, 166
vaccines, 374375
virology, 372
rubella, 384396
(AEFI), 394
handbook, 1314
simultaneous injections, 9, 84
sinusitis, 317
skin cleaning for vaccination, 70
skin disease, and tuberculosis vaccination, 414
skin penetration procedures, vaccination
recommendations, 172, 209, 210, 223
skin test. see Q-Vax Skin Test; tuberculin skin
test
smallpox, 1, 7, 104, 171, 482
smokers. see tobacco smoking
sodium borate, in vaccines, 470
solid organ transplant (SOT) recipients
hepatitis A, 204
hepatitis B, 222
rotavirus, 373
151154
sorbitol, in vaccines, 19, 472, 485
South Australia
age of consent, 26
details, 465466
hepatitis A, 105, 107, 199, 203, 204
online catch-up calculator, 39
108, 318, 324
special risk groups, 911, 104175. see also under
risk group names
Aboriginal and Torres Strait Islander
people, 35, 104112
adverse event following immunisation,
130133
anaesthesia or surgery, 36, 168
bleeding disorders, 168
blood product recipients, 33, 166167
correctional facility inmates, 174
drugs, persons who inject, 175
men who have sex with men, 174
migrants to Australia, 173174
normal human immunoglobulin (NHIG)
recipients, 166167
occupational risks, 169173
sex industry workers, 175
travellers, 127128
spica casts, injection sites, 74
splenectomy. see asplenia, persons with
Stamaril, 440
(AEFI), 444
and egg protein, 132

status of vaccination. see vaccination status and
history
steroids, and zoster vaccination, 453
straddle position, 7778
Streptococcus pneumoniae, 108, 155, 317. see also
subcutaneous (SC) injection, 6869, 72, 82
sucrose, in vaccines, 19, 485
sudden infant death syndrome (SIDS), 94, 143
surgery, vaccination recommendations before
or after, 168
Synagis, 457, 462
Synflorix, 320
systemic lupus erythematosus, vaccination
Tasmania
(AEFI) notification, 96
age of consent, 26
details, 465466
tattooists. see skin penetration procedures
tetanus, 397407
(AEFI), 405
bacteriology, 397
handbook, 1112
epidemiology, 398
precautions, 404405
tetanus-prone wounds, 402404
and travellers, 117
vaccines, 398400
405407
tetanus immunoglobulin (TIG), 403404
availability, 457
intramuscular use, 462463
intravenous use, 463
Tetanus Immunoglobulin-VF, 405, 463. see also
tetanus immunoglobulin (TIG)
tick-borne encephalitis vaccination, 121

tuberculosis, 121
typhoid, 122, 417, 419420
vaccine documentation, 116117
vaccines based on itinerary, 119126
vaccines required by International Health
Regulations, 116
yellow fever, 122, 440, 441442
Tripacel, 184, 306, 400
315, 406
tuberculin skin test, 116, 121, 410, 413
and measles-mumps-rubella (MMR)
vaccination, 278
tuberculosis (TB), 408415
(AEFI), 414
bacteriology, 408
BCG vaccination procedures, 411
handbook, 16
and Indigenous neonates, 106, 412
and travellers, 121
Twinrix (720/20), 200, 212
vaccination schedules, 215, 217
vaccination schedules, accelerated, 216
Twinrix Junior (360/10), 200, 211212
recommended doses and schedules, 202
Typherix, 417
Typhim Vi, 417
typhoid, 416422
bacteriology, 416
INDEX 521
Index
Therapeutic Goods Administration (TGA), 5, 7,

18, 94, 461, 482, 486
direct reporting to, 9697
thimerosal. see thiomersal, in vaccines
thiomersal, in vaccines, 19, 347, 469, 484
thrombocytopenia, 493
and passive immunisation, 464
and rubella vaccination, 384, 394
thymus disorders, and yellow fever
vaccination, 444
tick-borne encephalitis, and travellers, 121
tobacco smoking, and pneumococcal disease,
110, 327, 331
Torres Strait Islanders. see Aboriginal and
Torres Strait Islander people
Torres Strait Islands. see also Queensland, and
Japanese encephalitis vaccination, 111, 172,
264
transplants. see haematopoietic stem cell
transplant (HSCT) recipients; solid organ
transplant (SOT) recipients
transport, storage and handling of vaccines, 7,
2425. see also under individual disease names
travellers. see also Africa; Americas; Asia;
Europe; Middle East; Oceania; Saudi Arabia
children lower age limits for vaccines,
127128
cholera, 119
common infections, 113114
diphtheria, 117
immunocompromised persons, 147
influenza, 118, 256
Japanese encephalitis, 119, 263264
measles, 274
vaccine, 118
online information sources on health risks
for, 128129
pertussis, 117
pilgrimage to Mecca (Hajj and Umra), 16,
120, 129, 290
pre-travel information to acquire, 114117
rabies, 120, 358
routinely recommended vaccines, 117118
special risk groups, 127128
tetanus, 117

precautions, 421422
pregnancy and breastfeeding, 137, 139, 421
and travellers, 122
vaccines, 417418
vaccination, commonly asked questions,

473488
vaccination contraindications. see
contraindications to vaccination
vaccination documentation. see documentation
of vaccination
vaccination procedures. see procedures for
vaccination
vaccination recommendations. see under
individual disease names
vaccine administration. see administration of
vaccines
vaccine availability in Australia, 498499
vaccine components, commonly asked
questions about, 484486
vaccine effectiveness, 2021
vaccine efficacy, 2021
vaccine failure, 2021
Vaccine Information and Vaccine
Administration System (VIVAS), 102103
vaccine preparation. see preparation of vaccines
vaccine product information, 5, 6, 19. see also
under individual disease names, variations from
product information
vaccine safety, 2123. see also adverse events
following immunisation (AEFI)
commonly asked questions about, 481483
vaccine side effects. see adverse events
following immunisation (AEFI)
vaccine-preventable diseases, 175455. see also
under individual disease names
handbook, 1116
cholera, 11, 176181
diphtheria, 1112, 182190
Haemophilus influenzae type b (Hib), 12,
191197
influenza, 13, 243258
Japanese encephalitis, 13, 259266
measles, 1314, 267282

mumps, 1314, 295301
pertussis, 1112, 302316
Q fever, 15, 345352
rotavirus, 16, 372383
rubella, 1314, 384396
tetanus, 1112, 397407
typhoid, 416422
varicella, 1314, 423438
vaginal cancer, 233
valid consent. see consent
valid dose. see dosage
Vaqta Adult formulation, 200
Vaqta Paediatric/Adolescent formulation, 200
varicella, 423438
(AEFI), 433435
handbook, 1314
and children, 427428
epidemiology, 424
dose, 47
post-exposure vaccination, 429430, 437
precautions, 432433
pregnancy and breastfeeding, 140, 430431,
432
and travellers, 118
vaccines, 6869, 424426
437438
virology, 423
Western Australia
age of consent, 26
details, 465466
hepatitis A, 105, 107, 199, 203, 204
hepatitis A vaccine recommendations for

influenza, 92
pneumococcal disease, 15, 52, 57, 105, 108,
318, 324
pneumococcal vaccination, 5758
whooping cough. see pertussis
wildlife workers. see animals, persons working
with
women. see also breastfeeding; human
papillomavirus, female vaccination;
pregnancy
planning pregnancy, pregnant or
breastfeeding, 133142
rubella vaccination for women of childbaring age, 390, 391
World Health Organization Global Advisory
Committee on Vaccine Safety, 228
World Health Organization (WHO)
global elimination of measles, 268
Global Polio Eradication Initiative, 338
immunisation schedules for other
countries, 173
influenza pandemic, 245246
rabies vaccine recommendations, 358, 363,
367
serological testing for immunity to rubella,
391
and tuberculosis, 408
yellow fever vaccination requirements, 442
wounds
management after rabies or lyssavirus
exposure, 357, 361, 366, 367
tetanus prophylaxis for, 403404
tetanus-prone wounds, 402404
yeast, in vaccines, 472

yellow fever, 6869
(AEFI), 444
handbook, 16
precautions, 444
pregnancy and breastfeeding, 139, 443, 445
INDEX 523
Index
varicella-zoster immunoglobulin, 457

varicella-zoster virus (VZV), 423, 446. see also
varicella; zoster (herpes zoster)
Varilrix, 48, 425
vaccine components, 469, 469472, 471
Varivax Refrigerated, 425
438
vasovagal episode, 8788
vastus lateralis injection site, 73, 75, 78, 7980,
474
Vaxigrip, 247
Vaxigrip Junior, 247
ventrogluteal injection site, 73, 74, 76, 78, 8081,
83, 84, 474
veterinarians. see animals, persons working
with
Vibrio cholerae, 119, 176. see also cholera
Victoria
age of consent, 26
details, 465466
pneumococcal disease, 52, 56, 322
Victorian Cytology Service, 101
viral haemorrhagic fever. see yellow fever
Vivaxim, 200, 417
dosage and administration, 125126, 202,
419
recommended doses and schedules, 202
Vivotif Oral, 417418
vulval cancer, 233

and travellers, 122
vaccine, 440
virology, 439
yellow fever vaccine-associated viscerotropic
disease, 444, 445
Zagreb, 363
zoo workers. see animals, persons working
with
Zostavax, 323324, 447449
(AEFI), 454
precautions, 454
455
(AEFI), 454
handbook, 16
449450, 453
precautions, 453454
and recipients of normal human
immunoglobulin and other blood
products, 166
recommendations, 147, 159, 450453
vaccine, 6869, 447449
virology, 446
zoster immunoglobulin (ZIG), 460. see also
Zoster Immunoglobulin-VF (human)
Zoster Immunoglobulin-VF (human), 435437
Index
INDEX 525
If you are worried about yourself or your childs condition after

a vaccination, see your doctor or immunisation nurse as soon as
possible, or go directly to a hospital. It is also important to seek
medical advice if you or your child are unwell, as this may be
due to other illness rather than because of the vaccination.
Give extra fluids to drink. Do not overdress the baby if hot.

Although routine use of paracetamol after vaccination is
not recommended, if fever is present, paracetamol can be
given. The dose of paracetamol for a child up to 12 years of
age is 15mg/kg/dose, every 4 to 6 hours, up to four times a
day. Adults and children aged 12 years can receive 500 to
1000mg every 4 to 6 hours. Paracetamol should not be given
for more than 48 hours without seeking medical advice.
Many vaccine injections may result in soreness, redness,

itching, swelling or burning at the injection site for 1 to 2 days.
Paracetamol might be required to ease the discomfort.
Sometimes a small, hard lump (nodule) at the injection
site may persist for some weeks or months. This should
not be of concern and requires no treatment.
Concerns
Managing fever after immunisation
How to manage injection site discomfort

DTPa
dTpa
HepA
HepB
Hib
HPV
Influenza
IPV
diphtheria-tetanus-pertussis acellular (infant/child formulation)

diphtheria-tetanus-pertussis acellular (reduced antigen content formulation)
hepatitis A vaccine
hepatitis B vaccine
Haemophilus influenzae type b vaccine
human papillomavirus vaccine
influenza or flu vaccine
MenCCV
MMR
MMRV
13vPCV
23vPPV
Rotavirus
VV
meningococcal C conjugate vaccine

measles-mumps-rubella vaccine
measles-mumps-rubella-varicella vaccine
pneumococcal conjugate vaccine (13 serotypes)
pneumococcal polysaccharide vaccine (23 serotypes)
rotavirus vaccine
varicella vaccine
Key to table
Muscle aches


(IPV) and IPV-containing vaccines
Pneumococcal vaccines (conjugate

13vPCV and polysaccharide 23vPPV)
Muscle aches

Mild headache
Mild nausea
Measles-mumps-rubella vaccine
(MMR, MMRV see also varicella)
Influenza vaccine
Human papillomavirus vaccine (HPV)



In children, the following may also occur:
generally unhappy
Hepatitis A vaccine (HepA)
Haemophilus influenzae type b vaccine (Hib)
Diphtheria-tetanus-pertussis (acellular)
DTPa-containing vaccines and dTpa
(reduced antigen) vaccines

Temperature (fever, can be >39C)
Pustular rash (25 lesions), usually at
injection site, occasionally elsewhere
Vomiting and diarrhoea can occur up

to 7 days following vaccination
Rotavirus vaccine

generally unhappy
Loss of appetite
Headache (usually observed
in adolescents/adults)

Temperature (fever, can be >39.4C),
lasting 23 days, faint red rash (not
infectious), head cold and/or runny
nose, cough and/or puffy eyes
Swelling of salivary glands
Meningococcal C conjugate vaccine (MenCCV)

Localised pain, redness and swelling at
injection site
Hepatitis B vaccine (HepB)
If the adverse event following immunisation is unexpected, persistent and/or severe, or if you are worried about your or your childs condition, see your doctor or immunisation nurse as soon as possible, or go
directly to a hospital. Adverse events that occur following immunisation may be reported to the Therapeutic Goods Administration (TGA) (www.tga.gov.au) or to the Adverse Medicines Events line on 1300 134 237,
or discuss with your immunisation provider as to how reports are submitted in your state or territory.
Common adverse events following immunisation are usually mild and temporary (occurring in the first few days after vaccination, unless otherwise stated). Specific treatment is not usually required (see below).
Side effects following immunisation for vaccines used in the National Immunisation Program (NIP) schedule
INFORMATION SHEET ADVERSE EVENTS FOLLOWING IMMUNISATION

INFORMATION SHEET COMPARISON OF THE EFFECTS OF DISEASES AND THE SIDE EFFECTS OF NIP VACCINES
From The Australian Immunisation Handbook 10th Edition (see Handbook contents for more details)
DISEASE
EFFECT OF DISEASE
SIDE EFFECT OF VACCINE
Diphtheria bacteria spread by respiratory droplets; causes

severe throat and breathing difficulties.
Up to 1 in 7 patients die. The bacteria release a toxin, which can

produce nerve paralysis and heart failure.

Hepatitis A virus spread by contact or ingestion of faecally

contaminated water/food or through contact with the faecal
material of a person infected with hepatitis A.
At least 7 in 10 adult patients develop jaundice (yellowing of the skin and

eyes), fever, anorexia (decreased appetite), nausea, vomiting, hepatic
(liver) pain and malaise (tiredness).
About 1 in 5 will have local swelling, redness or pain at the injection

site. Serious adverse events are very rare.
Hepatitis B virus spread mainly by blood, sexual contact

or from mother to newborn baby; causes acute hepatitis
(liver infection) or chronic infection (carrier).
About 1 in 4 chronic carriers will develop cirrhosis or liver cancer.
About 1 in 20 will have local swelling, redness or pain at the injection site
and 2 in 100 will have fever. Anaphylaxis occurs in about 1 in 1 million.
Hib bacteria spread by respiratory droplets; causes

meningitis (infection of the tissues surrounding the brain),
epiglottitis (respiratory obstruction), septicaemia (infection
of the blood stream) and septic arthritis (infection in the
joints).
About 1 in 20 meningitis patients dies and about 1 in 4 survivors has

permanent brain or nerve damage. Epiglottitis is rapidly and invariably
fatal without treatment.

About 1 in 50 has fever. Serious adverse events are very rare.
Human papillomavirus virus spread mainly via sexual

contact; up to 80% of the population will be infected
with HPV at some time in their lives. Some HPV types are
associated with the development of cancer.
About 7 in 10 cervical cancers worldwide have been associated with

HPV-16 and 1 in 6 with HPV-18.
About 8 in 10 will have pain and 2 in 10 will have local swelling,

redness or pain at the injection site. Headache, fever, muscle aches and
tiredness may occur in up to 3 in 10 people. Serious adverse events are
very rare.
Influenza virus spread by respiratory droplets; causes

fever, muscle and joint pains, pneumonia. About 1 in 10 to
1 in 5 persons will get influenza every year.
There are an estimated 3000 deaths in people older than 50 years of

age each year in Australia.
Causes increased hospitalisation in the very young (under 5 years of
age) and the elderly. Other high-risk groups include pregnant women,
people who are obese, diabetics and others with certain chronic
medical conditions.

Fever occurs in about 1 in 10 children aged 6 months to 3 years.
Guillain-Barr syndrome occurs in about 1 in 1 million. Serious adverse
Measles highly infectious virus spread by respiratory

droplets; causes fever, cough and rash.
About 1 in 15 children with measles develops pneumonia and 1 in

1000 develops encephalitis (brain inflammation). For every 10 children
who develop measles encephalitis, 1 dies and many have permanent
brain damage. About 1 in 100 000 develops SSPE (brain degeneration),
which is always fatal.

injection site, or fever. About 1 in 20 develops a rash, which is noninfectious.
Low platelet count (causing bruising or bleeding) occurs after the 1st dose
of MMR vaccine at a rate of about 1 in 20 000 to 30 000. Serious adverse
Meningococcal infection bacteria spread by respiratory

droplets; causes septicaemia (infection of the blood stream)
and meningitis (infection of the tissues surrounding the
brain).
About 1 in 10 patients dies. Of those that survive, 1 to 2 in 10 have

permanent long-term problems, such as loss of limbs and brain
damage.

injection site, fever, irritability, loss of appetite or headaches (conjugate
vaccines).
About 1 in 2 has a local reaction (polysaccharide vaccine).
Mumps virus spread by saliva; causes swollen neck and

salivary glands, and fever.
One in 5000 children develops encephalitis (brain inflammation).

One in 5 males (adolescent/adult) develop inflammation of the testes.
Occasionally, mumps causes infertility or permanent deafness.
About 1 in 100 may develop swelling of the salivary glands. Serious

adverse events are very rare.
Pertussis bacteria spread by respiratory droplets; causes

whooping cough, with prolonged cough lasting up to 3
months.
About 1 in 125 babies under the age of 6 months with whooping

cough dies from pneumonia or brain damage.

Pneumococcal infection bacteria spread by respiratory

droplets; causes septicaemia (infection of the blood stream),
meningitis (infection of the tissues surrounding the brain)
and occasionally other infections.
About 3 in 10 people with meningitis die.

One-third of all pneumonia cases and up to half of pneumonia
hospitalisations in adults is caused by pneumococcal infection.

fever (conjugate vaccine).
Up to 1 in 2 has local swelling, redness or pain at the injection
site (polysaccharide vaccine).
Polio virus spread in faeces and saliva; causes fever,

headache and vomiting and may progress to paralysis.
While many infections cause no symptoms, up to 3 in 10 patients

with paralytic polio die, and many patients who survive are
permanently paralysed.
Local redness, pain and swelling at the injection site are common. Up to
1 in 10 has fever, crying and decreased appetite. Serious adverse events
are very rare.
Rotavirus virus spread by faecaloral route; causes

gastroenteritis, which can be severe.
Illness may range from mild diarrhoea to severe dehydrating diarrhoea

and fever, which can result in death.
Of children under 5 years of age, before vaccine introduction,
approximately 10 000 children were hospitalised, 115 000 needed
GP visits and 22 000 required an Emergency Department visit each
year in Australia.
Up to 3 in 100 may develop diarrhoea or vomiting in the week after

About 1 in 17 000 babies may develop intussusception in the
first few weeks after the 1st or 2nd vaccine doses.
Rubella virus spread by respiratory droplets; causes fever,

rash and swollen glands, but causes severe malformations in
babies of infected pregnant women.
Patients typically develop a rash, painful swollen glands and painful joints.
One in 3000 develops low platelet count (causing bruising or bleeding);
1 in 6000 develops encephalitis (brain inflammation).
Up to 9 in 10 babies infected during the first trimester of pregnancy
will have a major congenital abnormality (including deafness,
blindness or heart defects).

About 1 in 20 has swollen glands, stiff neck or joint pains. About 1 in
20 has a rash, which is non-infectious.
Low platelet count (causing bruising or bleeding) occurs
after the1st dose of MMR vaccine, at a rate of about 1 in 20 000 to 30 000.
Tetanus caused by toxin of bacteria in soil; causes painful

muscle spasms, convulsions, lockjaw.
About 2 in 100 patients die. The risk is greatest for the very young or old.

associated with extensive swelling of the limb, but this resolves completely
within a few days. Serious adverse events are very rare.
Varicella (chickenpox) highly contagious virus; causes

low-grade fever and vesicular rash (fluid-filled spots).
Reactivation of the virus later in life causes herpes zoster
(shingles).
One in 100 000 patients develops encephalitis (brain inflammation).

Infection during pregnancy can result in congenital malformations in
the baby. Infection in the mother around delivery time results in severe
infection in the newborn baby in up to one-third of cases.
About 1 in 5 has a local reaction or fever. About 3 to 5 in 100 may develop

a mild varicella-like rash. Serious adverse events are very rare.
NOTES

HEALTH AUTHORITIES
tract, with:
rib recession)
www.health.gov.au
0.050.1mL
0.3mL
0.1mL
0.4mL
0.15mL
0.5mL
0.2mL
10613 January 2014
1300 066 055

Northern Territory
08 8922 8044
Queensland
13 HEALTH (13 4325 84)

South Australia
1300 232 272 (8.30 am to 5.00 pm)

O N
New South Wales
Tasmania
03 6222 7666 or 1800 671 738
Victoria
1300 882 008

Western Australia
08 9388 4868
S A T
The Australian
02 6205 2300
Adrenaline dosage

M M U N
Freecall: 1800 671 811

improvement occurs.
02 6289 1555

see 1.4 Whats new
NOTES

HEALTH AUTHORITIES
tract, with:
rib recession)
www.health.gov.au
0.050.1mL
0.3mL
0.1mL
0.4mL
0.15mL
0.5mL
0.2mL
10613 January 2014
1300 066 055

Northern Territory
08 8922 8044
Queensland
13 HEALTH (13 4325 84)

South Australia
1300 232 272 (8.30 am to 5.00 pm)

O N
New South Wales
Tasmania
03 6222 7666 or 1800 671 738
Victoria
1300 882 008

Western Australia
08 9388 4868
S A T
The Australian
02 6205 2300
Adrenaline dosage

M M U N
Freecall: 1800 671 811

improvement occurs.
02 6289 1555

see 1.4 Whats new

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RECOGNITION AND TREATMENT OF ANAPHYLAXIS

CONTACT DETAILS FOR AUSTRALIAN, STATE AND TERRITORY GOVERNMENT

Australian Government health authorities

<1 year (approx. 510 kg)

710years (approx. 30kg)

12years (approx. 10kg)

1012years (approx. 40kg)

23years (approx. 15kg)

>12 years and adult (over 50 kg)

46years (approx. 20kg)

10613 January 2014

Doses of 1:1000 (one in one thousand) adrenaline:

1300 066 055

13 HEALTH (13 4325 84)

1300 232 272 (8.30 am to 5.00 pm)

New South Wales

03 6222 7666 or 1800 671 738

1300 882 008

10th Edition 2013 (updated January 2014)

State and territory government health authorities

Freecall: 1800 671 811

The Australian Immunisation Handbook 10th Edition 2013

For changes introduced in the

RECOGNITION AND TREATMENT OF ANAPHYLAXIS

CONTACT DETAILS FOR AUSTRALIAN, STATE AND TERRITORY GOVERNMENT

Australian Government health authorities

<1 year (approx. 510 kg)

710years (approx. 30kg)

12years (approx. 10kg)

1012years (approx. 40kg)

23years (approx. 15kg)

>12 years and adult (over 50 kg)

46years (approx. 20kg)

10613 January 2014

Doses of 1:1000 (one in one thousand) adrenaline:

1300 066 055

13 HEALTH (13 4325 84)

1300 232 272 (8.30 am to 5.00 pm)

New South Wales

03 6222 7666 or 1800 671 738

1300 882 008

10th Edition 2013 (updated January 2014)

State and territory government health authorities

Freecall: 1800 671 811

The Australian Immunisation Handbook 10th Edition 2013

For changes introduced in the

How to manage injection site discomfort

Managing fever after immunisation

Many vaccine injections may result in soreness, redness,

Give extra fluids to drink. Do not overdress the baby if hot.

If you are worried about yourself or your childs condition after

diphtheria-tetanus-pertussis acellular (infant/child formulation)

meningococcal C conjugate vaccine

Haemophilus influenzae type b vaccine (Hib)

Hepatitis A vaccine (HepA)

Hepatitis B vaccine (HepB)

Localised pain, redness and

Development of the 10th edition of the Handbook3

How to use the 10th edition Handbook5

PART 2 VACCINATION PROCEDURES

PART 3 VACCINATION FOR SPECIAL RISK GROUPS