What is Infanrix Hexa?
Infanrix Hexa is a vaccine that comes in the form of a powder and solvent that are mixed to make a solution for injection. The medicine contains the following active ingredients: toxoids (chemically weakened toxins) of diphtheria and tetanus, parts of the Bordetella pertussis (the bacterium that causes whooping cough), parts of the hepatitis B virus, inactivated polioviruses and sugar polysaccharides from the bacterium Haemophilus influenzae type b (Hib, a bacterium that causes meningitis).
What is Infanrix Hexa used for?
Infanrix Hexa is used to vaccinate children under the age of three against diphtheria, whooping cough, hepatitis B, polio and diseases caused by the bacterium. Hib (such as bacterial meningitis). The medicine is also used for booster vaccinations.
The medicine can only be obtained with a prescription.
How is Infanrix Hexa used?
The recommended vaccination schedule for Infanrix Hexa is two or three doses, given at least one month apart, usually within the first six months of life.
Infanrix Hexa is administered by deep intramuscular injection. The injection site should be alternated for subsequent administrations.A booster dose of Infanrix Hexa or a similar vaccine should be given at least six months after the last dose of the initial series. The choice of vaccine to use depends on official recommendations. Infanrix Hexa can be given to children vaccinated against hepatitis. B at birth.
How does Infanrix Hexa work?
Infanrix Hexa is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. Infanrix Hexa contains small amounts of:
- toxoids from bacteria that cause diphtheria and tetanus;
- toxoids and other purified proteins from the bacterium B. pertussis;
- surface antigen (proteins from the outer membrane) of the hepatitis B virus;
- inactivated polioviruses (types 1, 2 and 3);
- polysaccharides extracted from the membrane surrounding the bacterium Hib. The polysaccharides are chemically bound to the tetanus toxoid as a vehicle protein as this improves the response to the vaccine.
When a person is vaccinated, the immune system recognizes fragments of the virus as "foreign" and makes antibodies against that virus. If you are exposed to viruses or bacteria after vaccination, your immune system will be able to produce antibodies more quickly. thus protecting from the diseases caused by these microorganisms.
The vaccine is "adsorbed", which means that the active ingredient is fixed on aluminum compounds to stimulate a better response.
The surface antigens of the hepatitis B virus produced by a method known as "recombinant DNA technology": they are produced by a yeast that has received a gene (DNA) which makes it capable of producing the substance.
Infanrix Hexa is a combination of components already available in the European Union (EU) in other vaccines: elements of the diphtheria, tetanus, pertussis bacteria and hepatitis B virus were available in Infanrix HepB from 1997 to 2005, elements of the bacteria diphtheria, tetanus, pertussis, poliovirus and bacterium Hib they are available in other vaccines
How has Infanrix Hexa been studied?
Infanrix Hexa has been studied in nine studies involving a total of nearly 5,000 infants aged at least six weeks. Over 3,000 children received the initial vaccination series with Infanrix Hexa. The effects of Infanrix Hexa were compared to those of other separate vaccines containing the same active substances. The main measure of effectiveness in this study was the production of antibodies in the children.
Five other studies looked at the effects of a booster vaccination with Infanrix Hexa.
What benefit has Infanrix Hexa shown during the studies?
The nine studies showed that the initial vaccination series with Infanrix Hexa is just as effective in producing protective levels of antibodies as separate vaccines containing the same active ingredients. Overall, 95 to 100% of infants developed antibodies against diphtheria, tetanus, pertussis, poliovirus and bacterium Hib one month after the initial vaccination. The other studies showed that booster vaccinations with Infanrix Hexa were as effective as separate vaccines containing the same active substances one month after vaccine administration.
What is the risk associated with Infanrix Hexa?
The most common side effects seen with Infanrix Hexa (seen in more than one in 10 doses of the vaccine) are: loss of appetite, fever of 38 degrees Celsius and above, swelling, pain and redness at the injection site, fatigue, abnormal crying, irritability and restlessness. See the package leaflet for the full list of side effects reported with Infanrix Hexa.
Infanrix Hexa must not be used in children who may be hypersensitive (allergic) to the active substances or to any of the other ingredients in the vaccine, or to neomycin and polymyxin (antibiotics), or if children have had an allergic reaction after a vaccination containing elements from the bacteria of diphtheria, tetanus, pertussis, the hepatitis B virus, polio or the bacterium Hib. Infanrix Hexa must not be given to children with encephalopathies (a brain disease) of unknown cause for seven days following a vaccination containing components of the pertussis bacterium. Vaccination with Infanrix Hexa should be postponed in children with sudden high fever.
As with all vaccines, if Infanrix Hexa is given to very premature infants there is a risk of it causing apnea (short breathing pause). Infants' breathing should therefore be monitored for up to three days after vaccination.
Why has Infanrix Hexa been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Infanrix Hexa's benefits are greater than its risks for the initial and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B, polio and the pathologies caused by Hib. The Committee recommended that Infanrix Hexa be given marketing authorization.
Other information about Infanrix Hexa
On 23 October 2000 the European Commission released GlaxoSmithKline Biologicals s.a. a "Marketing Authorization" for Infanrix Hexa, valid throughout the European Union. The "Marketing Authorization" was renewed on 23 October 2005.
The full version of the EPAR for Infanrix Hexa can be found here.
Last update of this summary: 11-2008.
Information on Infanrix Hexa 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.