Assessment of GSK Biologicals' Tdap Candidate Vaccine Administered as a Booster (6th Dose) in Terms of Immunogenicity and Safety to Children and Adolescents Previously Vaccinated With Five Doses of an Acellular Pertussis-containing Vaccine.
Phase 3
Completed
- Conditions
- Acellular PertussisDiphtheriaTetanus
- Registration Number
- NCT00263679
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The aims of this study are to evaluate the safety and immunogenicity of a booster dose of GSK Biological's candidate Tdap vaccine containing 0.3 mg Al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of Pa-containing vaccine. The inclusion of hepatitis A vaccine (Havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 321
Inclusion Criteria
- Subjects previously enrolled and vaccinated in GSK Biologicals' studies APV-118 and APV-120 and who were 9 through 13 years of age
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Exclusion Criteria
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period
- Administration of immunoglobulins and/or blood products within 3 months prior to vaccination
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety after vaccination.
- Secondary Outcome Measures
Name Time Method Immunogenicity and safety after vaccination
Trial Locations
- Locations (1)
GSK Investigational Site
🇩🇪Husum, Schleswig-Holstein, Germany