Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.
Phase 3
Completed
- Conditions
- TetanusDiphtheriaAcellular Pertussis
- Registration Number
- NCT00406562
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will evaluate the safety and reactogenicity of booster dose of GSK Biologicals' dTpa vaccine (Boostrix) in Chinese children at 6-8 years of age.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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,
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,
Exclusion Criteria
- 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
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
GSK Investigational Site
🇨🇳Suining, China