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.
Full Title of Study: “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 DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Single
- Biological: INFANRIX
- Biological: BOOSTRIX
- Biological: HAVRIX
Clinical Trial Outcome Measures
- 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).
Participating in This Clinical Trial
- Male or female children between and including 18 -20 months of age at the time of the vaccination. – Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months. – Written informed consent obtained before study entry from the parents or guardians of the subject. – Free of obvious health problems as established by medical history and clinical examination before entering into the study. Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period. – Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
Gender Eligibility: All
Minimum Age: 18 Months
Maximum Age: 20 Months
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Provider of Information About this Clinical Study
- Overall Official(s)
- GSK Clinical Trials, Study Director, GlaxoSmithKline
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