Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

Phase 3

Completed

• Conditions: Tetanus; Diphtheria; Pertussis
• Interventions: Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis); Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)

• Registration Number: NCT00467519
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose.

Primary Objective:

- To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

Secondary/Observational Objectives:

* To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

* To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.

* To describe the safety profile following vaccine administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-04-30
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2010-11-04
• Results First Submitted QC: 2010-11-04
• Results First Posted: 2010-12-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-10
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1045

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)	DAPTACEL primed participants
Group 2	DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)	Pentacel primed participants

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level	Pre-dose and 30 days post-vaccination	Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.; Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL	Pre-dose and 30 days post-vaccination	Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.; Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis	30 Days post-vaccination	Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL; Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus	30 Days post-vaccination	Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer \< 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but \< 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.; Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis	Pre-dose and 30 Days Post-vaccination	Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).