Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 847 |
| Start date | 2006-09 |
| Completion | 2008-07 |
Conditions
- Infant
- Healthy
Interventions
- DT5aP-IPV-Hib 5-component Pertussis vaccine
- DT3aP-HBs-IPV
Primary outcomes
- To provide information concerning the safety after administration of PEDIACEL® booster dose — 0 to 3 Days post-vaccination
Countries
Germany