Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers

Phase 3 Completed 588 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. Primary Objectives: * To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. * To describe the post-dose 3 pertussis antibody responses. Secondary Objectives: * To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. * To describe the safety after each vaccination following co-administration with Prevenar®.

Timeline

Start: 2006-07
Primary completion: 2008-06
Completion: 2009-06

Outcome

Met primary endpoint

paper Seroprotection rates for DTaP(5)-IPV-Hib were high (noninferior to DTaP(3)-IPV/Hib for the primary series) PMID 21807056 ↗

Publications

Results Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Infanrix®-IPV+Hib	Unknown	0.5 ml	Intramuscular
Subject	Pediacel®	Vaccine	0.5 ml	Intramuscular
Background	Prevenar	Vaccine	0.5 ml	Intramuscular