What is Twinrix Pediatric?
Twinrix Pediatric is a vaccine that is available as a suspension for injection. It contains inactivated hepatitis A virus and parts of the hepatitis B virus as active substances. It is available in a 0.5 ml ampoule and a 0.5 ml pre-filled syringe.
What is Twinrix Pediatric used for?
Twinrix Pediatric is used to protect against hepatitis A and hepatitis B infection (diseases affecting the liver). It is used in children and adolescents between 1 and 15 years of age who are not already immune to these two diseases and who they are at risk of contracting both.
The medicine can only be obtained with a prescription.
How is Twinrix Pediatric used
? The recommended vaccination schedule for Twinrix Pediatric consists of three doses, with an interval of one month between the first two doses and a five-month interval between the second and third. It should be given by injection into the muscle of the upper arm or thigh.It is recommended that people receiving the first dose necessarily complete all three doses of Twinrix Pediatric.
A booster dose of Twinrix Pediatric, or a different hepatitis A or B vaccine may be given, according to official recommendations.
How does Twinrix Pediatric work?
Twinrix Pediatric is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defenses) to defend itself against a disease. Twinrix Pediatric contains small amounts of inactivated hepatitis A virus and the "surface antigen" (surface proteins) of the virus. "hepatitis B. When a person receives the vaccine, the immune system recognizes the viruses and surface antigens as" foreign "and makes antibodies against them. In the future, the immune system will be able to produce antibodies faster if it is exposed to viruses. 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 produced by a method called "recombinant DNA technology": they are made by a yeast that has received a gene (DNA) that makes it capable of making proteins. Twinrix Pediatric is identical to the Twinrix Adult vaccine, available in the European Union (EU) since 1996. The only difference between the two vaccines is the amount of vaccine in each vial or syringe. The active substances in Twinrix Pediatric and Twinrix Adult are available in the European Union from several years in other vaccines: Havrix Adult for protection against hepatitis A and Engerix-B for protection against hepatitis B.
How has Twinrix Pediatric been studied?
Since Twinrix Pediatric and Twinrix Adult contain identical ingredients, some of the data used to support the use of Twinrix Adult has been used to support the use of Twinrix Pediatric.
Two studies were conducted on a total of 180 children and adolescents, all receiving Twinrix Pediatric. The main measure of effectiveness was the percentage of children who developed protective levels of antibodies against hepatitis A and hepatitis B.
Other studies looked at the persistence of antibody levels after vaccination.
What benefit has Twinrix Pediatric shown during the studies?
The studies showed that Twinrix Pediatric produced an immune response at least equivalent to that seen during the Twinrix Adult studies.All children had satisfactory levels of antibodies to hepatitis A within two months, and nearly 100% had protective levels of antibodies to hepatitis B within six months (just before the third dose of the vaccine). Levels of antibodies to hepatitis A and hepatitis B increased after the third dose of the vaccine.
The other studies showed that the presence of antibodies was maintained for at least four years.
What is the risk associated with Twinrix Pediatric?
The most common side effect of Twinrix Pediatric (seen in more than 1 in 10 doses of the vaccine) is pain and redness at the injection site. For the full list of side effects reported with Twinrix Pediatric, see the Package Leaflet.
Twinrix Pediatric should not be used in people who may be hypersensitive (allergic) to one 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. Twinrix Pediatric vaccination should be postponed in patients with a sudden high fever. The vaccine should never be injected into a vein.
Why has Twinrix Pediatric been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Twinrix Pediatric's benefits are greater than its risks for use in non-immune children and adolescents aged 1 year up to and including 15 years who are at risk of infection with both hepatitis A and hepatitis B. The committee recommended the granting of a marketing authorization for Twinrix Pediatric.
Other information about Twinrix Pediatric:
On 10 February 1997 the European Commission released GlaxoSmithKline Biologicals s.a. a "Marketing Authorization" for Twinrix Pediatric, valid throughout the European Union. The "Marketing Authorization" was renewed on February 10, 2002 and February 10, 2007.
For the complete version of the Twinrix Pediatric EPAR click here.
Last update of this summary: 02-2008.
The information on Twinrix Pediatric 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.
