This is a summary of the European public assessment report (EPAR) for Infanrix hexa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Infanrix hexa.
For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.
Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib). Infanrix hexa contains the following active substances:
Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection. The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life. Infanrix hexa is given by deep injection into a muscle. Subsequent injections should be given in different areas.
A booster dose of Infanrix hexa or a similar vaccine must be given at least 6 months after the last dose of the initial course. The choice of booster vaccine depends on official recommendations.
The vaccine can only be obtained with a prescription. For more information, see the package leaflet.
Infanrix hexa is a vaccine that protects against a range of infections. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) to defend the body against the infections.
When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign’ and makes antibodies against them. The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses. This helps to protect against the diseases that these bacteria and viruses cause.
The vaccine is ‘adsorbed’. This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years. Over 3,000 of the children received a course of vaccination with Infanrix hexa. The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances. The main measure of effectiveness was the production of protective antibodies.
Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances. Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.
An additional five studies looked at the effects of a booster vaccination with Infanrix hexa. These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.
The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness. For the full list of side effects reported with Infanrix hexa, see the package leaflet.
Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde. It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib. Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine. Infanrix hexa should be postponed in infants with a severe sudden fever.
Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib. The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions. The European Medicines Agency therefore decided that Infanrix hexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Latest procedure affecting product information: WS2365
26/04/2023
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Product information documents contain:
Infanrix Hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type-b.