Clinical Trial: Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination

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

Official Title: Evaluation of GSK Biologicals' dTpa Booster Vaccine in Adults, Given 10 Years After Previous dTpa Boosting.

Brief Summary:

The purpose of this study is to assess the efficacy and safety of repeating dTpa booster in adults 10 years after previous booster vaccination with dTpa in a previous clinical study. Only subjects who received the booster vaccination in a previous clinical study are eligible for participation in this study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No new recruitment will be performed in this booster phase (see inclusion criteria)


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • In Group A:- Anti-diphtheria antibody concentrations [ Time Frame: One month after the booster dose ]
  • In Group A:- Anti-tetanus antibody concentrations [ Time Frame: One month after the booster dose ]


Original Primary Outcome: one month after the booster dose: anti-diphtheria and anti-tetanus antibody concentration

Current Secondary Outcome:

  • In all subjects:- Anti-diphtheria antibody concentration [ Time Frame: Prior to booster vaccination ]
  • Anti-tetanus antibody concentrations [ Time Frame: Prior to booster vaccination ]
  • Anti-pertussis antibody concentrations [ Time Frame: Prior to and 1 month after booster vaccination ]
  • Booster response to pertussis antigens [ Time Frame: One month after booster vaccination ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after booster vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after booster vaccination ]
  • Occurrence of serious adverse events [ Time Frame: Following booster vaccination ]


Original Secondary Outcome: anti-diphtheria, anti-tetanus, anti-pertussis antibody conc (before and 1 month post vacc) sol (4 days) and unsol (31 days) symptoms, SAEs

Information By: GlaxoSmithKline

Dates:
Date Received: October 22, 2007
Date Started: November 2007
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016