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

Phase 3
Completed
Conditions
Diphtheria
Tetanus
Whooping Cough
Polio
Haemophilus Influenzae Type b
Registration Number
NCT00662870
Lead Sponsor
Sanofi
Brief 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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1941
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.30 days post-vaccination 3
Secondary Outcome Measures
NameTimeMethod

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