2. What should I know before my child or I are given VAQTA?
Do not use if you or your child have ever had an allergic reaction to VAQTA or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you or your child have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if my child or I are taking other medicines?
Some medicines may interfere with VAQTA and affect how it works.
4. How is VAQTA given?
A doctor or nurse will give you or your child this vaccine as an injection, usually
into the upper arm.
The vaccine should not be injected directly into veins (intravenously).
5. What should I know after my child or I have been given VAQTA?
|
Things you should do
|
It is important to return at the scheduled date for the follow-up dose
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know whether VAQTA has affected
you.
VAQTA should not normally interfere with your ability to drive a car or operate machinery.
However, VAQTA may cause tiredness or weakness in some people.
|
|
Looking after your medicine
|
It is unlikely that you will be asked to store VAQTA. If you are:
Keep it where children cannot reach it.
Keep it in the refrigerator (not in the door compartment) between 2°C and 8°C. Do
not freeze this vaccine.
|
6. Are there any side effects?
Common side effects include: local reaction around the injection site such as pain,
soreness, tenderness, warmth, redness or swelling; fever, sore throat, runny nose,
cough, stomach pain, feeling sick (nausea), vomiting, diarrhoea, headache
Serious side effects may include allergic reactions such as skin rash; itching; or
hives (pinkish, itchy swellings on the skin).
For a complete list of side effects and more information, including what to do if
you or your child have any side effects, see Section
6. Are there any side effects? in the full CMI.
Hepatitis A vaccine, Inactivated (hepatitis A virus, inactivated)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using VAQTA. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using VAQTA.
Where to find information in this leaflet:
1. Why am I or my child being given VAQTA?
VAQTA is a vaccine used to help prevent hepatitis A. It can be given to children
12 months of age and older, teenagers and adults.
What is Hepatitis A
Hepatitis A is an infection of the liver caused by the hepatitis A virus. It can
be caught by coming into contact with an infected person who has poor sanitary habits,
eating or drinking foods prepared by an infected food handler, or, while uncommon,
by blood transfusion from an infected donor. Other circumstances that can increase
the risk of infection include:
travelling to areas where hepatitis A is common
living in a community with one or more recorded outbreaks within the last five years
being around groups of other children, for example, daycare centres
living in the same house as someone who is infected
having chronic liver disease or having had a liver transplant
sexual contact with someone who is infected
being infected with Human Immunodeficiency Virus (HIV)
working in the healthcare field
eating raw shellfish
sharing needles for injecting drugs
having a blood disorder requiring transfusion of blood products.
Symptoms of hepatitis A usually begin 2 to 8 weeks after coming into contact with
the virus. These include loss of appetite, feeling sick (nausea), vomiting, fever,
chills, tiredness, yellowing of the skin and/or eyes and dark urine. Most people
recover completely from hepatitis A disease. However, occasionally cases develop
into severe disease and death.
Hepatitis A occurs in Australia and New Zealand, but is not common. However, it is
very common in many parts of the world and the risk of infection is greatest in those
areas where hygiene and sanitation are poor. Immunisation against hepatitis A is
suggested for travellers to such areas, including Asia, India, Africa, Central and
South America.
How does it work
The vaccine contains inactivated virus and is injected into the body. The body then
produces its own protection by making disease-fighting substances (antibodies) to
fight the virus. The vaccine itself cannot cause the infection. If a vaccinated
person comes into contact with live virus the body is usually ready, and produces
antibodies to destroy it. However, as with all vaccines, 100% protection against
hepatitis A cannot be guaranteed.
Because hepatitis A infection can go undetected for a long period of time, it is possible
that an individual may already be infected at the time the vaccine is given. The
vaccine may not prevent hepatitis A in these individuals.
VAQTA will not protect against hepatitis caused by other agents or viruses (such as
hepatitis B, hepatitis C, hepatitis D, hepatitis E).
2. What should I know before my child or I are given VAQTA?
Warnings
Do not get VAQTA if:
you or your child are allergic to VAQTA, or any of the ingredients listed at the end
of this leaflet. Always check the ingredients to make sure you can use this medicine.
the expiry date on the pack has passed. If the vaccine is used after the expiry date
has passed, it may not work.
If you are not sure whether you or your child should be given VAQTA, talk to your
doctor.
Do not give VAQTA to children under 12 months of age.
Check with your doctor if you or your child:
have any medical conditions, especially the following:
bleeding problems
diseases which decrease the immune system, for example, AIDS
cancer
VAQTA may not work as well as it should if you or your child have diseases or conditions
which decrease the body's immune defence system. Your doctor will decide whether or
not to give the vaccine.
have an acute infection or a high temperature
Your doctor may decide to delay your injection of VAQTA.
have any allergies to any other medicines or any other substances, such as foods,
preservatives, latex rubber or dyes.
If you have not told your doctor about any of the above, tell them before you or your
child are given an injection of VAQTA.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects ?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. It is not
known whether the vaccine is harmful to an unborn baby when administered to a pregnant
woman. Your doctor will give you VAQTA only if it is clearly needed.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
whether VAQTA passes into breast milk. Your doctor will discuss the possible risks
and benefits of you being given VAQTA while breast-feeding.
Use in Children
Do not give VAQTA to children under 12 months of age.
The safety and effectiveness of VAQTA in these children have not been established.
3. What if my child or I are taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
VAQTA may not work as well as it should if you or your child are taking medicines
that decrease the immune system, such as corticosteroids (e.g. prednisone) or cyclosporin.
Your doctor will advise you if you are taking any of these or other medicines that
decrease the immune system. Your doctor will decide whether or not to give the vaccine.
Use with other vaccines
VAQTA may be given at the same time as yellow fever, typhoid, measles, mumps, rubella,
varicella and pneumococcal 7-valent conjugate vaccines. VAQTA may also be given at
the same time as an immune globulin injection. The injections should be given at
different places on the body and using separate syringes.
There is limited information available regarding the administration of other vaccines
at the same time as VAQTA. Your doctor will decide if VAQTA should be given with
other vaccines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VAQTA.
4. How is VAQTA given?
How much will you be given
Your doctor will decide on the dose of VAQTA that you will be given. This depends
on your age.
The usual dose for children and teenagers (12 months through 17 years of age) is 0.5
mL (approx. 25U).
The usual dose for adults (18 years and older) is 1.0 mL (approx. 50U).
How is it given
VAQTA is given as an injection, usually into your upper arm muscle by a doctor or
trained nurse.
The vaccine should not be injected directly into veins (intravenously).
Vaccination Schedule
VAQTA is generally given as a total of two doses. Each dose is given on a separate
visit.
The schedule for children and teenagers (12 months to 17 years) is:
1st dose: at elected date
2nd dose: 6 to 18 months later
The schedule for adults is:
1st dose: at elected date
2nd dose: 6 to 18 months later
The schedule for adults infected with HIV is:
1st dose: at elected date
2nd dose: 6 months later
It is important to return at the scheduled date for the follow-up dose.
If you have been given another hepatitis A vaccine as your 1st dose, VAQTA may be
given as the 2nd dose, 6 to 12 months later.
5. What should I know after my child or I have been given VAQTA?
Things you should do
Keep your follow-up appointment with your doctor or clinic.
It is important to have your follow-up dose of VAQTA at the appropriate time to make
sure the vaccine has the best chance of providing protection against the hepatitis
A virus.
Remind any doctor, dentist or pharmacist you visit that you are using VAQTA.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VAQTA
affects you.
VAQTA should not normally interfere with your ability to drive a car or operate machinery.
However, VAQTA may cause tiredness or weakness in some people. Make sure you know
how you react to VAQTA before you drive a car, operate machinery, or do anything else
that could be dangerous if you are tired or weak.
Looking after your medicine
It is unlikely that you will be asked to store VAQTA. However if you need to store
VAQTA:
Keep it where children cannot reach it.
Keep it in the refrigerator, but not in the door compartment.
Do not put VAQTA in the freezer, as freezing destroys the vaccine.
Keep the injection in the original pack until it is time for it to be given.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines, including vaccines, can have side effects. If you or your child do
experience any side effects, most of them are minor and temporary. However, some side
effects may need medical attention.
See the information below and, if you need to, ask your doctor, nurse, or pharmacist
if you have any further questions about side effects.
Common side effects in Children, Teenagers and Adults
Common side effects in children 12 months to 23 months of age
Additional common side effects in adults
Serious side effects in children/teenagers 2 years to 17 years of age and adults 18
years of age and older
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What VAQTA contains
|
Active ingredient
(main ingredient)
|
Hepatitis A virus protein
|
|
Other ingredients
(inactive ingredients)
|
Aluminium (as amorphous aluminium hydroxyphosphate sulfate)
Borax
Sodium chloride
|
Do not take this medicine if you are allergic to any of these ingredients.
VAQTA is made without any human blood or blood products. It does not contain any infectious
material.
The manufacture of this product includes exposure to bovine derived materials. No
evidence exists that any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
What VAQTA looks like
VAQTA comes in glass vials and prefilled syringes. It is a white milky liquid. Two
different vaccine doses are available:
approximately 25 Units in 0.5 mL of liquid
approximately 50 Units in 1 mL of liquid
In the injection vial products, the vial stopper contains dry natural latex rubber.
In the injection syringe products, the syringe plunger stopper and tip cap are not
made with natural rubber latex.
Australian Register Numbers:
VAQTA hepatitis A vaccine inactivated 25 units/0.5mL injection vial (AUST R 58534)
VAQTA hepatitis A vaccine inactivated 50 units/1mL injection vial (AUST R 58536)
VAQTA hepatitis A vaccine inactivated 25 units/0.5mL injection syringe (AUST R 58539)
VAQTA hepatitis A vaccine inactivated 50 units/1mL injection syringe (AUST R 58540)
Who distributes VAQTA
Merck Sharp & Dohme (Australia) Pty Ltd
Level 1, Building A, 26 Talavera Road
Macquarie Park NSW 2113
Tel: (+61) 02 8988 8000
This leaflet was prepared in October 2025.
RCN: 000028423-AU
Copyright © 2025 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.