NCT00343421

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

Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib When Both Vaccines Are Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 588 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 55 Days – 75 Days
• Healthy volunteers: Accepted

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®.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Poliomyelitis
• Haemophilus Influenzae Type b

Interventions

Type	Name	Description
BIOLOGICAL	PEDIACEL® and Prevenar®	0.5 mL each, IM (opposite thigh)
BIOLOGICAL	Infanrix®-IPV+Hib and Prevenar®	0.5 mL each, IM (opposite thigh)

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-06-01
• Completion: 2009-06-01
• First posted: 2006-06-23
• Last updated: 2016-06-03

Locations

2 sites across 2 countries: France, Poland