NCT00662870

Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,941 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 42 Days – 84 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)	0.5 mL, Intramuscular
BIOLOGICAL	Pentacel: DTaP-IPV/Hib	0.5 mL, Intramuscular

Timeline

• Start date: 2001-05-01
• Primary completion: 2004-01-01
• Completion: 2004-01-01
• First posted: 2008-04-21
• Last updated: 2012-01-31

Locations

26 sites across 1 country: United States