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

Learn more about:
Related Clinical Trial
Transcriptomic Responses for the Identification of Pathogens Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants Commercial Typhoid Tests Validation Trial Commercial Typhoid Tests Validation WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Safety and Immunogenicity of Typhax, a Typhoid Vaccine Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Investigating Enteric Fever – Salmonella Typhi and Paratyphi Challenge Study Induction of Gut Permeability by an Oral Vaccine Studies of Immune Responses to Orally Administered Vaccines in Developing Country Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants Typhoid Fever: Combined vs. Single Antibiotic Therapy Vaccines Against Salmonella Typhi Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults CVD 909 Vi Prime Boost Study Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Understanding Typhoid Disease After Vaccination Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

Brief Title

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

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 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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine

Secondary Outcome

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

Condition

Salmonella Infections

Intervention

Typhoid Vi polysaccharide

Study Arms / Comparison Groups

 Study Group
Description:  All participants will receive single dose of typhoid Vi polysaccharide vaccine on Day 0.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

200

Start Date

May 2012

Completion Date

December 2012

Primary Completion Date

September 2012

Eligibility Criteria

        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.
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01608815

Organization ID

TYP31 (SFY12079)

Secondary IDs

U1111-1124-7699

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Aventis K. K.


Verification Date

April 2014