HEXYON, hexavalent vaccine against diphtheria, tetanus, poliomyelitis, pertussis, Haemophilus influenzae type b infections, hepatitis B
INFECTIOLOGY - New medicinal product
Opinions on drugs - Posted on Oct 02 2015
Reason for request
No clinical benefit demonstrated when compared with INFARIX HEXA for the primary and booster vaccination in infants
- HEXYON is a hexavalent vaccine which has Marketing Authorisation for the primary and booster vaccination against diphtheria, tetanus, poliomyelitis, pertussis, Haemophilus influenzae type b infections and hepatitis B, in infants from 6 weeks to 24 months of age.
- There is another vaccine authorised in France for the primary and booster vaccination in infants: INFANRIX HEXA. The immunogenicity of HEXYON is not inferior to that of INFANRIX HEXA and its safety profile is comparable despite a higher frequency of local reactions.
Improvement in actual benefit
Évaluation des médicaments