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

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Brief Title

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

Official Title

Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Brief Summary

      The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine
      (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 toddlers, children, adolescents and adults, 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 4

Study Type

Interventional


Primary Outcome

Number of participants reporting unsolicited systemic adverse events; 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

March 2014

Completion Date

August 2015

Primary Completion Date

February 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 subject's parent (and subject, if applicable by local Institution Ethics Committee
             (IEC) / Institution Review Board (IRB) or country regulations), or another legally
             acceptable representative (and independent witness, if required by local regulations),
             and the assent form has been signed and dated by the subject (if applicable by the
             local IEC / IRB or country regulations)

          -  Subjects aged 18 years and older: informed consent form has been signed and dated by
             the subject (and an independent witness, if required by local regulations).

          -  Subject and subject's parent / legally acceptable representative (if applicable) 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., cholera outbreak situation
             or close contact to cholera case)

          -  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 or 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

Philippines

Location Countries

Philippines

Administrative Informations


NCT ID

NCT01949675

Organization ID

SHC02

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