Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
|ClinicalTrials.gov Identifier: NCT01608815|
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
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.
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Salmonella Infections Typhoid Fever Bacterial Infections||Biological: Typhoid Vi polysaccharide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Study Group
All participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.
Biological: Typhoid Vi polysaccharide
0.5 mL, Intramuscular
Other Name: Typhim Vi
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608815
|Nagoya City, Aichi, Japan|
|Shinjuku, Tokyo, Japan|
|Study Director:||Medical Director||Sanofi Aventis K. K.|