An open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis adsorbed vaccine (RE...

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Reference: EUCTR2010-021068-13

An open-label, randomised, multicentre study to evaluate the immunogenicity and safety of a booster dose of diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis adsorbed vaccine (REPEVAX) administered concomitantly versus non-concomitantly with an influenza vaccine (VAXIGRIP) to subjects of 60 years of age and older

Woman and Man

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Extract

- To demonstrate that REPEVAX administered concomitantly with VAXIGRIP in subjects 60 years of age and older is at least as immunogenic as REPEVAX administered alone and - To demonstrate that VAXIGRIP administered concomitantly with REPEVAX in subjects 60 years of age and older is at least as immunogenic as VAXIGRIP administered alone.


Inclusion criteria

  • Repevax: Antibodies response to Diphtheria Toxoid ,Tetanus Toxoid, Pertussis Toxoid*, Filamentous Haemagglutinin, Pertactin, Fimbriae Types 2 and 3, Poliomyelitis Virus Type 1, Poliomyelitis Virus Type 2, Poliomyelitis Virus Type 3,Vaxigrip: Immunisation against Influenza,*For pertussis immunisation the MedDRA LLT code is 10069577