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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
200
0.5 mL, Intramuscular
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Osaka, Osaka, Japan
Unnamed facility
Shinjuku, Tokyo, Japan
Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Time frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28 post-vaccination
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, \>100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
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