Clinical Trial: Safety and Immunogenicity Study of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Followed by 2 Doses of a Diphtheria, Tetanus and Poliomyelitis Vaccine (REVAXIS) in Subjects of 40 Years of Age or Older

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

Official Title: An Open-label, Multicentre Study to Evaluate the Immunogenicity and Safety of One Dose of a Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis Vaccine (REPEVAX) Fo

Brief Summary:

Primary objective:

  • To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
  • To evaluate the percentage of subjects with antibody titre ≥5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects

Secondary objectives:

  • If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years
  • To describe the immune responses to REPEVAX in these subjects
  • To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects

Detailed Summary:
Sponsor: MCM Vaccines B.V.

Current Primary Outcome:

  • Diphtheria seroprotection rate [ Time Frame: 28 to 35 days afeter each vaccine administration ]
  • Tetanus seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ]
  • Polio seroprotection rate [ Time Frame: 28 to 35 days after each vaccine administration ]
  • Pertussis response rate [ Time Frame: 28 to 35 days after REPEVAX administration ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: MCM Vaccines B.V.

Dates:
Date Received: January 31, 2011
Date Started: January 2011
Date Completion:
Last Updated: June 6, 2012
Last Verified: June 2012