Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Phase 4
Terminated
- Conditions
- Acellular PertussisDiphtheriaTetanus
- Registration Number
- NCT00544271
- Lead Sponsor
- GlaxoSmithKline
- 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 Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 720
Inclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc) Occurrence of local injection site reactions (1M after vacc).
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
GSK Investigational Site
🇦🇺Carlton, Victoria, Australia