A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic

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Brief Title

A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic

Official Title

Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (ShancholTM) in Subjects Aged 1 Year and Older in Dominican Republic

Brief Summary

      The aim of the study is to generate safety and immunogenicity data with Shanchol in The
      Philippines

      Objectives:

        -  To describe the safety after each dose of Shanchol vaccine.

        -  To describe the immunogenicity after each dose of Shanchol vaccine.
    

Detailed Description

      Healthy study participants aged 1 year and older will receive two doses of vaccine 14 days
      apart, and will be assessed baseline immunogenicity (pre-vaccination) and 14 days after each
      vaccine dose. Safety data will be collected for 14 days after the first dose and 30 days
      after the second dose.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Number of participants reporting unsolicited systemic adverse events (AEs); solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™)

Secondary Outcome

 Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline

Condition

Cholera

Intervention

Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell

Study Arms / Comparison Groups

 Study Group 1
Description:  Participants aged 1 through 4 years at enrollment

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

336

Start Date

April 2015

Completion Date

July 2016

Primary Completion Date

September 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 1 year and older on the day of inclusion

          -  Subjects aged 1 through 17 years: Informed consent form has been signed and dated by
             the parent(s) or another legally acceptable representative and assent form has been
             signed and dated by the subject if aged 9 through 17 years Subjects aged 18 years and
             older: Informed consent form has been signed and dated by the subject

          -  Subjects and/or subject's parent or an adult family member delegated by parent /
             legally acceptable representative are able to attend all scheduled visits and to
             comply with all trial procedures

          -  Subjects aged less than 2 years only: Born at full term of pregnancy (≥ 37 weeks)
             and/or with a birth weight ≥ 2.5 kg.

        Exclusion Criteria:

          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of
             non-childbearing potential, a female must be pre-menarche or post-menopausal for at
             least 1 year, surgically sterile, or using an effective method of contraception or
             abstinence from at least 4 weeks prior to the first vaccination and until at least 4
             weeks after the last vaccination)

          -  Participation at the time of study enrollment or planned participation during the
             present trial period in another clinical trial investigating a vaccine, drug, medical
             device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned
             receipt of any vaccine in the 4 weeks following any trial vaccination except for
             influenza vaccination, which may be received at least 2 weeks before or after any
             study vaccination

          -  Previous vaccination against cholera (in the previous 5 years) with either the trial
             vaccine or another vaccine

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

          -  History of cholera infection, confirmed either clinically, serologically, or
             microbiologically

          -  At high risk for cholera infection during the trial (i.e., subject residing in areas
             with poor sanitary conditions)

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily

          -  Current alcohol abuse or drug addiction

          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might
             interfere with trial conduct or completion

          -  Intake of oral antibiotics within one week prior to enrollment

          -  Moderate or severe acute illness / infection (according to investigator judgment) on
             the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective
             subject should not be included in the study until the condition has resolved or the
             febrile event has subsided

          -  Identified as an Investigator or employee of the Investigator / study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study

          -  Diarrhea (3 or more loose/watery stools within a 24-hours period) within 6 weeks prior
             to enrollment. A prospective subject should not be included in the study until the
             condition has resolved

          -  Intake of anti-diarrhea medicine within one week prior to enrollment

          -  Abdominal pain or cramps, loss of appetite, nausea, or vomiting within 24 hours prior
             to enrollment. A prospective subject should not be included in the study until the
             condition has resolved.
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

Dominican Republic

Location Countries

Dominican Republic

Administrative Informations


NCT ID

NCT02434822

Organization ID

SHC03

Secondary IDs

U1111-1127-7355

Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Pasteur SA


Verification Date

March 2018