NCT00355654

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

Safety and Immunogenicity of Booster Vaccination With PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Booster Vaccination With Infanrix® Hexa When Both Vaccines Are Co-Administered With Prevenar® to Toddlers 11-18 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 847 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Months – 18 Months
• Healthy volunteers: Accepted

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.

Conditions

• Infant
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	DT5aP-IPV-Hib 5-component Pertussis vaccine	0.5 mL, IM
BIOLOGICAL	DT3aP-HBs-IPV	0.5 mL, IM

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-09-01
• Completion: 2008-07-01
• First posted: 2006-07-24
• Last updated: 2015-01-07

Locations

84 sites across 1 country: Germany