Tetanus Clinical Trial
Official title:
Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared
to local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in
participants in China.
Primary objective:
- To describe diphtheria and tetanus seroprotection rates and pertussis booster response
rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),
local DT vaccine (in children), and local Td vaccine (in adolescents and adults).
Secondary Objectives:
- To further describe in each group the immunogenicity of the study vaccines at baseline
and 1 month after vaccination.
- To describe the safety of the study vaccines
Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single
booster dose of local DT or local Td vaccine, depending on the age subgroup.
Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be
assessed in all subjects up to Day 35 post vaccination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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