Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
|Official Title:||Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency & Reactogenicity of DTPa - INFANRIX & dTpa - BOOSTRIX Vaccines Admnd to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR).|
- Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
- Occurrence of local injection site reactions (1M after vacc).
- 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).
|Study Start Date:||May 2003|