Tetanus Clinical Trial
Official title:
Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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