Tetanus Clinical Trial
Official title:
Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents
This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose
in adolescents in Japan.
Primary Objective:
- To assess the immunogenicity of Tdap (SP306) when administered as a single dose in
Japanese adolescents
Secondary Objective:
- To assess the safety of Tdap vaccine when administered as a single dose in Japanese
adolescents.
All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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