NCT00467519

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

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,045 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tetanus
• Diphtheria
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)	0.5 mL, IM
BIOLOGICAL	DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)	0.5 mL, IM

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2007-04-30
• Last updated: 2014-02-07
• Results posted: 2010-12-03

Locations

43 sites across 2 countries: United States, Canada