Clinical Trial: Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of
Brief Summary: To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
- Occurrence of local injection site reactions (1M after vacc).
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
- Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
- SAEs (full study).
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: October 15, 2007
Date Started: May 2003
Date Completion:
Last Updated: September 6, 2016
Last Verified: September 2016