Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus antigen vaccine
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Vivaxim.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your doctor has weighed
the risks of you having Vivaxim against the benefits they expect it will have for
If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.
Keep this leaflet. You may need to read it again.
What VIVAXIM is used for
Vivaxim is a vaccine used to help prevent typhoid fever and hepatitis A disease in
adults aged 16 years and older who are at risk of these diseases.
How it works
Vivaxim works by causing your body to produce its own protection against typhoid fever
and hepatitis A infection. It does this by making substances called antibodies in
the blood, which fight the typhoid bacteria and hepatitis A virus. If a vaccinated
person comes into contact with the typhoid or hepatitis A organisms, the body is usually
ready to destroy them.
Your body usually takes two weeks after vaccination to develop protection against
typhoid fever and hepatitis A infection.
Initial protection is provided by one dose of Vivaxim. For long-lasting protection
against hepatitis A virus a booster vaccination with a hepatitis A vaccine will be
required 6 to 36 months after vaccination with Vivaxim. The body does not develop
long-term protection against typhoid fever and repeat vaccinations are required to
Most people will produce enough antibodies against typhoid fever and hepatitis A infection.
However, as with all vaccines, 100% protection cannot be guaranteed.
The vaccine will not give you typhoid fever or hepatitis A infection.
The chance of a severe reaction from Vivaxim is very small, but the risks from not
being vaccinated against typhoid fever or hepatitis A infection may be very serious.
Before you are given VIVAXIM
When you must not be given it
You have had a severe reaction to a previous injection of this vaccine.
Do not have Vivaxim if you have an allergy to:
Vivaxim or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
Shortness of breath, wheezing or difficulty breathing
Swelling of the face, lips, tongue or other parts of the body
Skin rash, itching or hives.
Do not have Vivaxim if you have a fever or acute illness. Minor infections are not
a reason to delay vaccination.
Do not give Vivaxim to persons younger than 16 years. The safety and effectiveness
of Vivaxim in persons under 16 years have not yet been established.
Do not have Vivaxim after the expiry date printed on the pack. Do not have Vivaxim
if the packaging is torn or shows signs of tampering.
Talk to your doctor or pharmacist if you are not sure whether you should have Vivaxim.
Before you are given it
Tell your doctor if you have ever had a serious allergic reaction to a vaccine.
Tell your doctor if you have an infection or high temperature.
Your doctor may decide to delay vaccination until the illness has passed. A mild illness,
such as a cold, is not usually a reason to delay vaccination.
Tell your doctor if you have, or have had, any medical conditions, especially the
Lowered immunity due to diseases such as some blood disorders, malaria, kidney disease
requiring dialysis, HIV/AIDS or cancer
Lowered immunity due to treatment with medicines such as corticosteroids, cyclosporin,
or other medicines used to treat cancer (including radiation therapy)
Leukaemia or any other cancers of the blood, bone marrow or lymph system.
If you have lowered immunity then the vaccine may not work as well as it would in
Tell your doctor if you have allergies to:
Any other medicines
Any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or intend to become pregnant.
Vivaxim is not recommended for use during pregnancy. If there is a need to consider
Vivaxim during your pregnancy, your doctor will discuss with you the benefits and
risks of having it.
Tell your doctor if you are breast-feeding.
Your doctor will discuss the possible risks and benefits of having Vivaxim during
Having other medicines
As Vivaxim does not contain any live bacteria or viruses, it can generally be given
at the same time as other inactivated vaccines, but at a different injection site.
Vivaxim can be given at the same time as yellow fever vaccine at different injection
Other medicines should be taken as usual after the vaccination.
How VIVAXIM is given
Vivaxim is given as a slow injection into the muscle of your upper arm.
Vivaxim should not be injected into the veins or into the buttocks.
How much is given
The dose is one millilitre of the mixed vaccine.
When it is given
Vivaxim should be given 14 days before you may be exposed to the typhoid fever and
hepatitis A. For long term protection against infection with hepatitis A virus you
should obtain a booster dose of hepatitis A vaccine 6-36 months after your initial
dose of Vivaxim. If you are at ongoing risk of infection with typhoid fever, you should
be revaccinated against typhoid fever, every 3 years.
After having VIVAXIM
Things you must do:
Keep an updated record of your vaccinations
Attend any other appointments made by your doctor or nurse
Report any side effects to your doctor.
Tell your doctor or pharmacist as soon as possible if you do not feel well after having
Vivaxim may have unwanted side effects in a few people. All medicines, including
vaccines, can have side effects. Sometimes they are serious, most of the time they
are not. You may need medical treatment if you get some of the side effects. Ask
your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
Local reaction around the injection site such as redness, pain, swelling or hardness
Generally feeling unwell
Soreness, aching muscles, muscle tenderness or weakness (not caused by exercise)
Nausea or diarrhoea
These are the more common side effects of Vivaxim. Mostly these are mild and short-lived.
Less common side effects include itchiness of the skin, dizziness and a rash. Very
rarely some patients experience fainting, vomiting, abdominal pain and increased liver
Tell your doctor immediately if you notice any of the following:
Abscess at the injection site
Unusual bleeding, bruising or purple spots on the skin
Skin rash, itchy spots or red lumps on the skin
Painful, swollen joints
Swelling of the glands in the neck, armpit or groin
Itchiness, hives or rash over the body.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body
Pinkish, itchy swellings on the skin, also called hives or nettle rash, shortness
of breath, wheezing or trouble breathing.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
All of these side effects are very rare.
Other side effects not listed above may occur in some patients. Tell your doctor
or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any
Vivaxim is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store Vivaxim:
Keep it in the refrigerator, between 2°C and 8°C. Do not freeze Vivaxim
Keep it where children cannot reach it
Keep Vivaxim in the original pack until it is time for it to be given.
Freezing destroys the vaccine.
What it looks like and contents of the pack
Vivaxim is a combination vaccine contained in a dual chamber syringe. One chamber
contains the hepatitis A vaccine, which appears as a white suspension, the other chamber
contains the typhoid vaccine, which appears as a clear liquid. The two vaccine components
become mixed together when the plunger is depressed.
25 micrograms Salmonella typhi Vi Polysaccharide
160 antigen units hepatitis A virus antigen.
Dibasic sodium phosphate dihydrate
Monobasic sodium phosphate dihydrate
Water for injections
Aluminium hydroxide hydrate
Medium 199 (Hanks) (including phenylalanine)
Bovine Serum Albumin (trace).
The hepatitis A virus that this vaccine contains was grown in a cell line derived
from human embryonic lung in the 1960s.
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.
Name and address of the sponsor
sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Tel: 1800 818 806
sanofi-aventis new zealand limited
56 Cawley St
Tel: 0800 283 684
AUST R number
AUST R 82745
Date of preparation
05 March 2020