Clinical Trial: Booster Study of Combined Diphtheria-tetanus-acellular Pertussis Vaccine in Healthy Adults

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

Official Title: Single-blind, Clinical Study of the Immunogenicity and Reactogenicity of SB Biologicals' dTpa, pa Vaccines and a Td Vaccine, Given as a Booster Dose to Healthy Adults, From the Age of 18 Years Onwards

Brief Summary: The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Occurrence of solicited local and general symptoms [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the first injection ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the second injection ]
  • Occurrence of solicited local symptoms and fever [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after the second injection ]
  • Occurrence of general solicited symptoms to vaccination, other than fever [ Time Frame: Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration ]
  • Occurrence of unsolicited symptoms [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccine administration ]
  • Occurrence of serious adverse experiences to vaccination [ Time Frame: Within 31 days (Day 0 - Day 30) after each vaccine administration ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: Immediately prior to the booster vaccination ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: One year after the vaccination in a subset of subjects from all the groups ]
  • Immunogenicity with respect to components of the study vaccines [ Time Frame: 2, 3, 4 and 5 years after the vaccination ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: December 23, 2010
Date Started: September 1997
Date Completion:
Last Updated: December 23, 2010
Last Verified: December 2010