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VAXELIS, hexavalent vaccine against diphtheria, tetanus, poliomyelitis, pertussis, Haemophilus influenzae type b infections, hepatitis B

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Jan 18 2018

Reason for request

Inclusion

No clinical benefit demonstrated for the primary and booster vaccination in infants

 

  • VAXELIS 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 of age.
  • There are two other hexavalent vaccines authorised in France for the primary and booster vaccination in infants: INFANRIX HEXA and HEXYON. The immunogenicity of VAXELIS is not inferior to that of INFANRIX HEXA and its safety profile is comparable despite a higher frequency of local reactions and fever.

 

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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