Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
Phase 2
Completed
- Conditions
- Acellular PertussisTetanusDiphtheria
- Registration Number
- NCT00263692
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
Inclusion Criteria
- Healthy children between and including 4 and 6 years of age.
- Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.
Read More
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.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Immunogenicity after vaccination.
- Secondary Outcome Measures
Name Time Method Immunogenicity and safety after vaccination.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Mechanicsville, Virginia, United States