Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01608815
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE May 28, 2012
First Posted Date  ICMJE May 31, 2012
Results First Submitted Date  ICMJE March 7, 2014
Results First Posted Date  ICMJE May 12, 2014
Last Update Posted Date May 12, 2014
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
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 Measures  ICMJE
 (submitted: May 28, 2012)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
  • 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 Measures  ICMJE
 (submitted: May 28, 2012)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
Official Title  ICMJE 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 Description 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Salmonella Infections
  • Typhoid Fever
  • Bacterial Infections
Intervention  ICMJE Biological: Typhoid Vi polysaccharide
0.5 mL, Intramuscular
Other Name: Typhim Vi
Study Arms  ICMJE Experimental: Study Group
All participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.
Intervention: Biological: Typhoid Vi polysaccharide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged 2 years and above on the day of inclusion
  • 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.

Exclusion Criteria:

  • 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)
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
  • 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
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating 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
  • Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
  • Previous vaccination against Salmonella typhi disease with either the trial vaccine or another vaccine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01608815
Other Study ID Numbers  ICMJE TYP31 (SFY12079)
U1111-1124-7699 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Aventis K. K.
PRS Account Sanofi
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP