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.

Detailed Summary: 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.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine [ Time Frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination) ]

Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).


Original Primary Outcome: Number of participants with a 4 fold increase of Vi antibody titer between Day 0 (before vaccination) and Day 28 (after vaccination) after a single dose of SP093 vaccine. [ Time Frame: Day 28 post vaccination ]

Vi antibody titers will be assessed by enzyme-linked immunosorbent assay (ELISA)


Current Secondary Outcome:

  • Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
  • Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine [ Time Frame: Day 28 post-vaccination ]
    Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
  • Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    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.


Original Secondary Outcome: Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring throughout the trial. [ Time Frame: Day 0 through Day 28 post vaccination ]

Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Body temperature), Headache, Malaise, and Myalgia


Information By: Sanofi

Dates:
Date Received: May 28, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 15, 2014
Last Verified: April 2014