Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
Phase 3
Completed
- Conditions
- DiphtheriaAcellular PertussisTetanus
- Registration Number
- NCT00452686
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 660
Inclusion Criteria
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
Exclusion Criteria
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
- Secondary Outcome Measures
Name Time Method Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇳Suining, China