Bacterial Infections Clinical Trial
Official title:
Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects
This study is designed to assess the immunogenicity and safety of typhoid Vi polysaccharide
vaccine in Japanese participants to support registration of the product in Japan.
Primary Objective:
To describe the seroconversion rate (percentage of subjects with at least a 4-fold increase
of their Vi antibody titer) between Day 0 before vaccination and Day 28 after vaccination
with typhoid Vi polysaccharide (SP093) vaccine in subjects aged 2 years and above.
Secondary Objectives:
- To describe the safety profile of a single dose of typhoid Vi polysaccharide vaccine up
to 28 days after vaccination, in subjects aged 2 years and above.
- To describe the immune response following a single dose of typhoid Vi polysaccharide
vaccine in subjects aged 2 years and above.
All participants will receive a single dose of typhoid Vi polysaccharide vaccine on Day 0 and be assessed for immunogenicity on Day 0 before vaccination and on Day 28 post-vaccination. All participants will be monitored for safety for 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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