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