NCT00290342

Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants

A Multicentric Study to Compare the Immunogenicity, Safety & Reactogenicity of GSK Biologicals' DTPa-IPV Vaccine vs. Co-administration of GSK's DTPa Vaccine & Sanofi-Pasteurs' IPV Vaccine at Different Injection Sites, to Healthy Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 8 Weeks – 12 Weeks
• Healthy volunteers: Accepted

Summary

DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

Participants in this Phase IIIb study will either receive GSK Biologicals' combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus (DTPa-IPV) vaccine or co-administration of GSK Biologicals' combined diphtheria-tetanus-acellular pertussis (DTPa) vaccine and Sanofi-Pasteurs' inactivated poliovirus vaccine. Vaccines for both groups will be administered at 2, 4 and 6 months of age. Two blood samples will be collected during the course of the study: prior to vaccination and one month after the third vaccine dose.

Conditions

• Tetanus
• Acellular Pertussis
• Diphtheria

Interventions

Type	Name	Description
BIOLOGICAL	DTPa-IPV	3 intramuscular injections
BIOLOGICAL	DTPa	3 intramuscular injections
BIOLOGICAL	IMOVAX Polio®	3 intramuscular injections

Timeline

• Start date: 2006-01-01
• Primary completion: 2007-01-01
• Completion: 2007-01-23
• First posted: 2006-02-13
• Last updated: 2018-10-29
• Results posted: 2018-10-29

Locations

9 sites across 1 country: South Korea