What is Tritanrix HepB?
Tritanrix HepB is a vaccine in the form of a suspension for injection. The product contains as active components toxoids (also called anatoxins; they are toxins chemically deprived of toxic power) of diphtheria and tetanus, Bordetella pertussis (bacterium causing whooping cough) inactivated (ie dead) and parts of the hepatitis B virus.
What is Tritanrix HepB used for?
Tritanrix HepB is used to vaccinate infants aged at least six weeks against diphtheria, tetanus, pertussis and hepatitis B.
The medicine can only be obtained with a prescription.
How is Tritanrix HepB used?
Tritanrix HepB is given by deep injection into the muscle, preferably the thigh. The recommended vaccination schedule includes three administrations at least four weeks apart, within the first six months of life. If the newborn has not been vaccinated against hepatitis B at birth, Tritanrix HepB can be administered from the eighth week of age. In areas where hepatitis B is widespread, the practice of vaccination at birth should be maintained, starting the administration of Tritanrix HepB upon reaching six weeks of age.
A booster vaccination is recommended before the completion of the second year of life.
How does Tritanrix HepB work?
Tritanrix HepB is a vaccine. Vaccines "teach" the immune system (the body's natural defenses) to defend itself against disease. Tritanrix HepB contains small amounts of:
- toxoids of bacteria that cause diphtheria and tetanus;
- B. pertussis dead whole, which is the bacterium that causes whooping cough;
- the surface antigen (proteins present on the surface) of the hepatitis B virus.
When the newborn is vaccinated, his immune system recognizes the parts of bacteria and viruses contained in the vaccine as "foreign" and produces antibodies to fight them. Later, if this person naturally comes into contact with the bacteria or viruses, their immune system will be able to produce antibodies more quickly. This helps protect the vaccinated person against diseases caused by these bacteria and viruses. The vaccine is "adsorbed"; this means that the toxoids and parts of the hepatitis B virus are fixed on aluminum compounds in order to induce a better immune response. The surface antigens of the hepatitis B virus are produced with the so-called "recombinant DNA technology", ie by inserting a gene (DNA) into a yeast which thus becomes capable of producing proteins.
The active substances in Tritanrix HepB have been available in the European Union (EU) for some years in other vaccines.
How has Tritanrix HepB been studied?
The effects of Tritanrix HepB were first tested in experimental models before being studied in humans.
Tritanrix HepB was studied in six studies involving a total of 872 infants aged 7-20 weeks, all of whom were vaccinated with the product. The main measure of effectiveness was the production of defense antibodies in infants after the first series of vaccinations.
Subsequent studies looked at the effects of the vaccine in younger infants and the maintenance of antibody levels after vaccination.
What benefit has Tritanrix HepB shown during the studies?
Studies have shown that induction of levels of antibody protection against diphtheria, tetanus and hepatitis B occurred in at least 98% of the infants. At least 92% of the infants developed levels of antibody protection against pertussis.
Further studies showed that initiation of vaccination upon reaching six weeks of age was appropriate and that a booster administration is required in the second year of age to maintain protection.
What is the risk associated with Tritanrix HepB?
The most common side effects associated with Tritanrix HepB (seen with more than 1 in 10 vaccine administration) are sleepiness, feeding problems, fever, redness, swelling, pain, unusual crying and irritability. For the full list of side effects reported with Tritanrix HepB, see the Package Leaflet.
Tritanrix HepB should not be used in infants who may be hypersensitive (allergic) to any of the active substances or to any of the other ingredients. It should also not be used in infants who have had allergic reactions after diphtheria, tetanus, pertussis or hepatitis B vaccination. Administration of Tritanrix HepB should be delayed in infants with severe sudden fever and avoided if the child has had encephalopathy (a disease of the brain). ) of unknown cause in the week following a previous vaccination with a vaccine containing pertussis.
As with all vaccines, if Tritanrix HepB is used in very premature infants, there is a risk of apnea (short pauses during breathing). In this case, breathing should be monitored for up to three days after vaccination. .
Why has Tritanrix HepB been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Tritanrix HepB outweigh the risks in "active immunization against diphtheria, tetanus, pertussis and hepatitis B of infants of at least six weeks of age and recommended the release of the" marketing authorization for Tritanrix HepB.
Other information about Tritanrix HepB:
On 19 July 2006 the European Commission released GlaxoSmithKline Biologicals s.a. a "Marketing Authorization" for Tritanrix HepB, valid throughout the European Union. This authorization was renewed on July 19, 2001 and July 19, 2006.
For the full version of the Tritanrix HepB EPAR click here.
Last update of this summary: 04-2008.
The information on Tritanrix HepB - vaccine 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.
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