At a glance
ClinicalIndex Comparison Record- ✓Age 4–6 years at vaccination
- ✓Prior receipt of 4 doses of Infanrix and 3 doses of IPOL during first 2 years of life
- ✓Prior MMR vaccination in second year of life
- ✓Free of obvious health problems on medical history and brief physical exam
- ✕Any investigational or non-registered drug/vaccine within 30 days prior to study vaccination or planned during study
- ✕Prior or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or vaccination against these after age 2
- ✕Known exposure to diphtheria, tetanus, pertussis, or polio prior to vaccination
- ✕Prior receipt of OPV vaccine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety, Immunogenicity and Consistency of 3 Manufacturing Lots of DTaP-IPV Vaccine Versus Separate Injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV Administered as Booster Doses to Healthy Children 4-6 Years, Each Co-administered With Merck's MMR Vaccine
In Brief
A Phase 3 clinical trial evaluating SB213503 lot 1, SB213503 lot 2, and 4 other interventions for Tetanus and 2 related conditions. Completed, enrolled 4,209 participants across 24 sites.
Detailed Summary
The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine \[Infanrix\] and Aventis Pasteur's IPV vaccine \[IPOL\]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.
Study Details
Timeline
Interventions
SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.