

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.
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 you.
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-term protection against hepatitis A virus a booster vaccination with an inactivated 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 maintain protection.
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

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
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 an infection or high temperature.
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.
Tell your doctor if you have allergies to:
Any other medicines
Any other substances, such as foods, preservatives or dyes
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 breastfeeding.

Having other medicines

VIVAXIM can be given at the same time as yellow fever vaccine at different injection sites.
Other medicines should be taken as usual after the vaccination.

How VIVAXIM is given

VIVAXIM is given as a slow injection into your upper arm muscle by a doctor or nurse.
VIVAXIM should not be injected directly 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 are exposed to risk of both typhoid fever and hepatitis A. For long term protection against infection with hepatitis A virus you should obtain a booster dose of AVAXIM® (hepatitis A vaccine) 6-36 months after your dose of VIVAXIM. 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having VIVAXIM.
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.
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 enzymes.
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.
Pinkish, itchy swellings on the skin, also called hives or nettle rash, shortness of breath, wheezing or trouble breathing.
All of these side effects are very rare.


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.

Product description

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.


Active ingredients:
25 mcg Purified Salmonella typhi (Ty-2 Strain) Vi Polysaccharide
160 antigen units hepatitis A virus antigen.
Other ingredients:
Sodium chloride
Sodium phosphate - dibasic dihydrate
Sodium phosphate - monobasic dihydrate
Water for injections
Aluminium hydroxide
Medium 199 (Hanks)
Polysorbate 80
Neomycin (trace)
Bovine Serum Albumin (trace).

Name and address of the sponsor

sanofi-aventis australia pty ltd
Talavera Corporate Centre -
Building D
12 - 24 Talavera Road
Macquarie Park NSW 2113
Tel: 1800 829 468
New Zealand:
sanofi-aventis new zealand limited
Level 8
56 Cawley St
New Zealand
Tel: 0800 727 838
AUST R number
AUST R 82745
Date of preparation
25 February 2016