NCT00255047

Safety and Immune Response of Different Pediatric Combination Vaccines.

Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,167 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

Summary

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

Conditions

• Diphtheria
• Polio
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	DAPTACEL®. (DTaP), IPOL®., and ActHIB®.	0.5 mL, Intramuscular
BIOLOGICAL	Pentacel®: DTaP-IPV/Hib combined	0.5 mL, Intramuscular
BIOLOGICAL	DTaP-IPV and ActHIB®	0.5 mL, Intramuscular
BIOLOGICAL	Pentacel®: DTaP-IPV/Hib combined	0.5 mL, Intramuscular

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-07-01
• Completion: 2009-02-01
• First posted: 2005-11-17
• Last updated: 2014-02-14
• Results posted: 2010-11-10

Locations

36 sites across 1 country: United States