Clinical Trial: Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional



Official Title: Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects

Brief 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.