NCT00263692

Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety

Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Acellular Pertussis
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3

Timeline

• Start date: 2002-11-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2005-12-09
• Last updated: 2016-09-15

Locations

15 sites across 1 country: United States