Clinical Trial: Study of Reduced-antigen-content Acellular Pertussis Vaccine and Diphtheria-Tetanus-Acellular Pertussis Vaccine

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

Official Title: A Phase III, Blinded, Randomised, Monocentre, Comparative Clinical Study of the Immunogenicity, Reactogenicity and Safety of a Single Booster Dose of SB Biologicals' Candidate dTpa and pa Vaccines and

Brief Summary: The purpose of this study is to assess the immunogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly, SmithKline Beecham Biologicals) reduced-antigen-content acellular pertussis vaccine and reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine in comparison with Tedivax-Adult™/ Td-Rix™

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa vaccine and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity with respect to components of the study vaccines (in subjects receiving the dTpa, pa vaccines and Tedivax-Adult™/ Td-Rix™) [ Time Frame: One month after the booster dose (Month 1) ]
  • Occurrence of solicited local adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ]
  • Occurrence of solicited general adverse experiences [ Time Frame: During the 15-day (Day 0-14) follow-up period after vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ]
  • Occurrence of any serious adverse experiences [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination ]
  • Lymphoproliferation specific for pertussis toxoid, filamentous haemagglutinin and pertactin/ Cell mediated immunity response [ Time Frame: At pre-vaccination (Day 0) and Month 1 post-vaccination ]
  • Immunogenicity with respect to components of the study vaccines (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: One month after the second and third booster dose (Month 12) ]
  • Occurrence of solicited local adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ]
  • Occurrence of solicited general adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: During the 15-day (Day 0-14) follow-up period after the second and third vaccine dose ]
  • Occurrenceof unsolicited symptoms (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ]
  • Occurrence of any serious adverse experiences (in subjects who did not respond to diphtheria or tetanus toxoid after the first booster dose) [ Time Frame: Within the 31-day (Day 0 -30) follow-up period after vaccination after the second and third vaccine dose ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: December 16, 2010
Date Started: October 1997
Date Completion:
Last Updated: December 16, 2010
Last Verified: December 2010