NCT00148941

Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,209 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

* Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine. * Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections. * Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit. * A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Conditions

• Tetanus
• Acellular Pertussis
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	SB213503 lot 1	SB213503 lot 1 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICAL	SB213503 lot 2	SB213503 lot 2 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICAL	SB213503 lot 3	SB213503 lot 3 vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICAL	Infanrix	Infanrix vaccine was administered as a single dose by intramuscular injection in the deltoid at Day 0.
BIOLOGICAL	IPOL	IPOL vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.
BIOLOGICAL	M-M-R II	M-M-R II vaccine was administered as a single dose by subcutaneous injection in the deltoid at Day 0.

Timeline

• Start date: 2005-01-06
• Primary completion: 2006-11-01
• Completion: 2006-12-04
• First posted: 2005-09-08
• Last updated: 2020-02-05
• Results posted: 2020-02-05

Locations

24 sites across 1 country: United States