At a glance
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Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects
In Brief
A Phase 3 clinical trial evaluating Typhoid Vi polysaccharide for Salmonella Infections and 2 related conditions. Completed, enrolled 200 participants across 3 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular