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

NCT01608815 | Completed Phase 3 Results

• 2 other identifiers: TYP31 (SFY12079)U1111-1124-7699
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Salmonella Infections; Typhoid Fever; Bacterial Infections

Keywords

Salmonella infections; Typhoid fever; Bacterial infections; Typhoid vaccine

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Secondary Outcomes (3)

• Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine

  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

  Day 28 post-vaccination

• Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine

  Day 0 up to Day 7 post-vaccination

Study Arms (1)

Study Group

EXPERIMENTAL

All participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.

Biological: Typhoid Vi polysaccharide

Interventions

Typhoid Vi polysaccharide BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Typhim Vi

Study Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent or other legally representative. Also subjects 7 to 11 years of age will provide oral assent and subjects 12 to 19 years of age will provide written assent form
• Able to attend all scheduled visits/phone call and to comply with all trial procedures
• For a woman of childbearing potential, use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

You may not qualify if:

• Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
• History of typhoid fever or Salmonella typhi infection, confirmed either clinically, serologically, or microbiologically
• Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
• Known or suspected congenital or current/previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Planned participation in another clinical trial during the present trial period
• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
• Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
• Planned receipt of any vaccine during the trial period
• Clinical or known serological evidence of systemic illness including hepatitis B, hepatitis C and/or Human immunodeficiency virus (HIV) infection
• Ineligible according to the investigator's clinical judgment
• Known pregnancy, or a positive (serum and/or urine) pregnancy test
• Currently breastfeeding a child
• Known thrombocytopenia, contraindicating intramuscular (IM) vaccination
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Salmonella Infections; Typhoid Fever; Bacterial Infections

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Aventis K. K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2012
• First Posted: May 31, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 12, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-04

Locations

JP (3)