ClinicalTrials.gov

History of Changes for Study: NCT02434822
A Study of Two Doses of Oral Cholera Vaccine (Shancholâ„¢) in Subjects Aged 1 Year and Older in Dominican Republic
Latest version (submitted March 22, 2018) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2015 None (earliest Version on record)
2 September 29, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 August 23, 2016 Recruitment Status and Study Status
4 March 22, 2018 Study Status and References
Comparison Format:

Scroll up to access the controls

Study NCT02434822
Submitted Date:  April 30, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: SHC03
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
Secondary IDs: U1111-1127-7355 [WHO]
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Recruiting
Study Start: April 2015
Primary Completion: August 2015 [Anticipated]
Study Completion: March 2016 [Anticipated]
First Submitted: April 30, 2015
First Submitted that
Met QC Criteria:
April 30, 2015
First Posted: May 5, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 30, 2015
Last Update Posted: May 5, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi Pasteur, a Sanofi Company
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Cholera
Keywords: Cholera
Shanchol™
Cholera Vaccine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 336 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Study Group 1
Participants aged 1 through 4 years at enrollment
Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
1.5 mL, Oral administration
Other Names:
  • Shanchol™
Experimental: Study Group 2
Participants aged 5 through 14 years at enrollment
Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
1.5 mL, Oral administration
Other Names:
  • Shanchol™
Experimental: Study Group 3
Participants aged 15 years and above at enrollment
Biological: Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell
1.5 mL, Oral administration
Other Names:
  • Shanchol™
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
2. 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.
Secondary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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.
Open or close this module Contacts/Locations
Central Contact Person: Public Registry Sanofi Pasteur
Email: RegistryContactUs@sanofipasteur.com
Study Officials: Medical Director
Study Director
Sanofi Pasteur SA
Locations: Dominican Republic
[Recruiting]
Santo Domingo, Dominican Republic
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Related Info
Description: Related Info
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services