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

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ClinicalTrials.gov Identifier: NCT02434822
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE April 30, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date March 26, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Number of participants reporting unsolicited systemic adverse events (AEs); solicited systemic reactions including serious adverse events following administration Oral Cholera Vaccine (Shanchol™) [ Time Frame: Day 0 up to Day 44 post oral vaccination ]
    Solicited systemic reaction: Vomiting, Diarrhea, Fever (temperature), Abdominal pain, Itching, Rash, Weakness, Cough, Vertigo, and Dryness of Mouth
  • Summary of titers of serum vibriocidal antibodies Before and 14 days after each Oral Cholera Vaccine (Shanchol™) [ Time Frame: Day 0 (before) and Day 14 Post oral vaccination ]
    Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02434822 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
Number of participants with 4-fold or greater rises in titers 14 days after each Oral Cholera Vaccine (Shanchol™) relative to baseline [ Time Frame: Day 0 (before) and Day 14 Post oral vaccination ]
Serum vibriocidal antibody (against V. cholerae O1 Inaba serogroup, V. cholerae O1 Ogawa serogroup, and V. cholerae O139 serogroup) will be assessed using the microtiter technique.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cholera
Intervention  ICMJE Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
1.5 mL, Oral administration
Other Name: Shanchol™
Study Arms  ICMJE
  • Experimental: Study Group 1
    Participants aged 1 through 4 years at enrollment
    Intervention: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
  • Experimental: Study Group 2
    Participants aged 5 through 14 years at enrollment
    Intervention: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
  • Experimental: Study Group 3
    Participants aged 15 years and above at enrollment
    Intervention: Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
Publications * Cordero De Los Santos L, Feris-Iglesias J, Aloysia D'Cor N, Midde VJ, Patnaik BN, Thollot Y, Rasuli A, Desauziers E. Bivalent oral cholera vaccine in participants aged 1 year and older in the Dominican Republic: A phase III, single-arm, safety and immunogenicity trial. Hum Vaccin Immunother. 2018 Jun 3;14(6):1403-1411. doi: 10.1080/21645515.2018.1430540. Epub 2018 Feb 22.

*   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: April 30, 2015)
336
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year 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 Dominican Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434822
Other Study ID Numbers  ICMJE SHC03
U1111-1127-7355 ( 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 Pasteur SA
PRS Account Sanofi
Verification Date March 2018

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