What is Ambirix?
Ambirix is a vaccine available as a suspension for injection, containing inactivated (ie killed) hepatitis A virus and parts of the hepatitis B virus as active ingredients.
What is Ambirix used for?
Ambirix is used to protect against hepatitis A and hepatitis B (diseases that affect the liver), in people between one and 15 years of age who are not already immune to these two diseases.
Ambirix is administered according to a two-dose vaccination protocol, so protection from hepatitis B may not be achieved until after the second dose. For this reason, Ambirix should only be used in cases where there is a low risk of infection. from hepatitis B during the vaccination course and when it is safe that the two-dose vaccination course can be completed.
The medicine can only be obtained with a prescription.
How is Ambirix used?
The Ambirix vaccination schedule consists of two doses administered 6-12 months apart. The vaccine is given by injection into the upper arm muscle or into the thigh in very young children. People who receive the first dose must complete the course with Ambirix.
In the case of a booster dose for hepatitis A or B, Ambirix or a separate vaccine for hepatitis A or B can be given.
How does Ambirix work?
Ambirix is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defenses) to defend itself against a disease. Ambirix contains small amounts of the inactivated hepatitis A virus and the "surface antigen" (surface proteins) of the hepatitis A virus. hepatitis B. When a child receives the vaccine, the immune system recognizes the viruses and surface antigens as 'foreign' and makes antibodies against them. If exposed to viruses in the future, the immune system will be able to produce antibodies faster. Antibodies help protect against diseases caused by these viruses.
The vaccine is "adsorbed". This means that the viruses and surface antigens are fixed on aluminum compounds to stimulate a better response. The surface antigens of the hepatitis B virus are obtained by a method called "recombinant DNA technique": they are produced by a yeast that has received a gene (DNA) which makes it capable of producing proteins.
The active substances of Ambirix are available in other vaccines authorized in the European Union (EU): Ambirix contains the same components as Twinrix Adult, authorized since 1996, and Twinrix Pediatric, authorized since 1997. The three vaccines are used to protect against the same diseases but Twinrix Adult and Twinrix Pediatric are administered following a three dose protocol.
How has Ambirix been studied?
As Ambirix and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult has been taken back to justify the use of Ambirix.
Three main studies of Ambirix involved a total of 615 subjects from one year of age. All the children received two doses of Ambirix six months apart. Two of the studies compared Ambirix with other hepatitis A and B vaccines. The main measure of effectiveness was the proportion of vaccinated children who developed protective levels of antibodies one month after the last injection.
An additional study of 208 subjects compared the vaccine efficacy when the interval between the two injections was from 6 months to 12 months.
What benefit has Ambirix shown during the studies?
Ambirix led to the development of protective levels of antibodies against hepatitis A and B in 98 to 100% of children vaccinated one month after the last injection. These levels were maintained in over 93% of the children after two years. Ambirix has been shown to be as effective as other hepatitis A and B vaccines once the full vaccination course was completed. However, complete protection from hepatitis B was only found after the second dose of Ambirix was administered.
The additional study showed similar levels of protection with Ambirix with an interval of 6 and 12 months between injections.
What is the risk associated with Ambirix?
The most common side effects of Ambirix (seen in more than 1 in 10 doses of the vaccine) are headache, loss of appetite, pain at the injection site, redness, fatigue (tiredness) and irritability or nervousness. For the complete list. of the side effects reported with Ambirix, see the package leaflet.
Ambirix must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to neomycin (an antibiotic). It should also not be used in people who have had an allergic reaction after receiving hepatitis A or hepatitis B vaccines. Ambirix vaccination should be postponed in patients with a sudden high fever. The vaccine should never be injected into a vein.
Why has Ambirix been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ambirix's benefits are greater than its risks for use in non-immune individuals from 1 year up to and including 15 years for protection against hepatitis A infection and hepatitis B. The Committee recommended the granting of a marketing authorization for Ambirix.
Other information about Ambirix:
On 30 August 2002 the European Commission released GlaxoSmithKline Biologicals s.a. a "Marketing Authorization" for Ambirix, valid throughout the European Union. The "Marketing Authorization" was renewed on 30 August 2007.
For the full version of the Ambirix EPAR click here.
Last update of this summary: 02-2008.
The information on Ambirix published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
