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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01608815
First received: May 28, 2012
Last updated: October 15, 2013
Last verified: October 2013

May 28, 2012
October 15, 2013
May 2012
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Vi antibody titers will be assessed by enzyme-linked immunosorbent assay (ELISA)
Same as current
Complete list of historical versions of study NCT01608815 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Body temperature), Headache, Malaise, and Myalgia
Same as current
Not Provided
Not Provided
 
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
Immunogenicity and Safety of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine Given in Japanese Subjects

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.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Salmonella Infections
  • Typhoid Fever
  • Bacterial Infections
Biological: Typhoid Vi polysaccharide
0.5 mL, Intramuscular
Other Name: Typhim Vi
Experimental: Study Group
All participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.
Intervention: Biological: Typhoid Vi polysaccharide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01608815
TYP31 (SFY12079), U1111-1124-7699
No
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Aventis K. K.
Sanofi
October 2013

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