Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.

NCT00662870 Phase 3 COMPLETED

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	1941
Start date	2001-05
Completion	2004-01

Conditions

• Diphtheria
• Tetanus
• Whooping Cough
• Polio
• Haemophilus Influenzae Type b

Interventions

• DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
• Pentacel: DTaP-IPV/Hib

Primary outcomes

• Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. — 30 days post-vaccination 3

Countries

United States