International Nonproprietary Name (INN): Diphtheria, tetanus, acellular pertussis, inactivated
EMEA 2005 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Hexavac is a hexavalent vaccine which contains combined antigens derived from Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, polio virus and Haemophilus influenzae type b. It is developed for primary and booster vaccination of children against the viruses and bacteria mentioned above.
The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules. These studies showed the protective efficacy of Hexavac against the above diseases in infants.
The most common adverse events were transient local reactions (pain, redness, swelling at the injection site) and systemic reactions (loss of appetite, fever, drowsiness, irritability).
The CHMP, on the basis of quality, efficacy and safety data submitted,authorisedconsideres that the overall benefit /risk ratio for Hexavac remains favourable in the approved indication.
The following adverse effects were reported very rarely: allergic reaction, chills, fatigue, hypotonic-
hyporesponsive episode, malaise, oedema, pallor, swelling or oedema of the entire limb( ), transient