Clinical Trial: Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliom

Brief Summary:

Primary objectives:

To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.

Secondary objectives:

•Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)

•Secondary safety objective: To describe the safety profile after vaccination in each group


Detailed Summary:
Sponsor: MCM Vaccines B.V.

Current Primary Outcome:

  • Diphtheria seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ]
  • Tetanus seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ]
  • Polio seroprotection rate [ Time Frame: 28 to 35 days after vaccine administration ]
  • Pertussis antibody titre [ Time Frame: 28 to 35 days after vaccine administration ]
  • Flu geometric mean of titres ratio [ Time Frame: 28 to 35 days after vaccine administration ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Solicited injection-site reactions, solicited systemic adverse reactions [ Time Frame: From Day 0 to Day 7 following REPEVAX vaccination ]
  • Unsolicited injection-site adverse reactions and systemic adverse events [ Time Frame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination ]
  • Number and proportion of Serious adverse events [ Time Frame: From the first visit to the last visit of the subject ]


Original Secondary Outcome: Same as current

Information By: MCM Vaccines B.V.

Dates:
Date Received: November 17, 2010
Date Started: October 2010
Date Completion:
Last Updated: November 27, 2015
Last Verified: October 2011