Study to Compare Booster Vaccination With Pediacel® to Infanrix® Hexa When Both Are Co-Administered With Prevenar®

Phase 3 Completed 847 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of the study is to provide data on the safety and immunogenicity of Pediacel® to allow its use as a fourth dose administered to 11-18 months old toddlers at the same time as Prevenar®. Primary Objective: To evaluate the safety of Pediacel® booster dose co-administered with Prevenar® to toddlers at 11-18 months of age. Secondary Objectives: * To describe the incidence rate of severe fever within four days post-vaccination * To describe the antibody responses to all antigens in a subgroup of subjects at baseline and post-vaccination.

Timeline

Start: 2006-09
Primary completion: 2007-09
Completion: 2008-07

Publications

Berner R, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Safety and immunogenicity of fully liquid DTaP(5)-IPV-Hib pediatric combination vaccine (Pediacel(R)) compared to DTaP(3)-HBV-IPV/Hib (Infanrix(R) Hexa) when coadministered with heptavalent pneumococcal conjugate vaccine (PCV7) as a booster at 11-18 months of age: a phase III, modified double-blind, randomized, controlled, multicenter study. Vaccine. 2012 Jul 27;30(35):5270-7. doi: 10.1016/j.vaccine.2012.05.064. Epub 2012 Jun 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Infanrix hexa	Vaccine	0.5 ml	Intramuscular
Subject	Pediacel®	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.