At a glance
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Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
In Brief
A Phase 3 clinical trial evaluating Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) and DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) for Tetanus and 2 related conditions. Completed, enrolled 1,045 participants across 43 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
0.5 mL, IM
0.5 mL, IM