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Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Details
| Lead sponsor | Sanofi Pasteur, a Sanofi Company |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 2167 |
| Start date | 2005-11 |
| Completion | 2009-02 |
Conditions
- Diphtheria
- Polio
- Pertussis
Interventions
- DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
- Pentacel®: DTaP-IPV/Hib combined
- DTaP-IPV and ActHIB®
- Pentacel®: DTaP-IPV/Hib combined
Primary outcomes
- Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. — 30 Days post-dose 3 vaccination
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer. - Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) — 30 Days post-dose 3 vaccination
- Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. — 30 Days post-dose 3 vaccination.
Countries
United States