Clinical Trial: Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compar
Brief Summary: This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after the third dose (Month 7) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Immunogenicity with respect to components of the study vaccines [ Time Frame: One month after each dose (Months 1, 2 and 7) ]
- Occurrence of solicited local and general symptoms [ Time Frame: Within 15 days (day 0 -14) after each vaccine dose. ]
- Occurrence of unsolicited symptoms [ Time Frame: Within 31 days (day 0-30) after each vaccine dose. ]
- Occurrence of serious adverse events [ Time Frame: Until 31 days (day 0-30) after the last vaccine dose. ]
- Occurrence of large local swelling reported [ Time Frame: Within 15 days (day 0-14) after each vaccine dose ]
- Use of concomitant medication taken [ Time Frame: Within 31 days (day 0-30) after each vaccine dose ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: February 10, 2011
Date Started: April 2003
Date Completion:
Last Updated: September 14, 2016
Last Verified: September 2016
