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A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children

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ClinicalTrials.gov Identifier: NCT00760825
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : June 17, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.

Condition or disease Intervention/treatment Phase
Vibrio Cholerae Biological: killed bivalent (O1 and O139)whole cell oral cholera vaccine Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label Post Licensure Trial to Evaluate the Safety and Immunogenicity of Indigenously Manufactured Killed Bivalent (O1 and O139) Whole Cell Oral Cholera Vaccine(Shanchol™)
Study Start Date : March 2012
Primary Completion Date : April 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Vaccine
killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™)
Biological: killed bivalent (O1 and O139)whole cell oral cholera vaccine
1.5 ml given twice orally, 14 days apart
Other Name: Shanchol™

Outcome Measures

Primary Outcome Measures :
  1. Proportion of subjects with diarrhea [ Time Frame: 28 days ]
  2. Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies relative to baseline [ Time Frame: 14 days after each dose ]

Secondary Outcome Measures :
  1. Geometric mean serum vibriocidal titers [ Time Frame: baseline and 14 days after each dose ]
  2. Proportion of subjects with any of the following adverse events: immediate reactions, serious adverse events, reactogenicity: headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, fever, loss of appetite, general ill feeling [ Time Frame: 28 days ]

Eligibility Criteria

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Ages Eligible for Study:   1 Year to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Male or female adults aged 18-40 years and children aged 1 -17 years who the investigator believes will comply with the requirements of the protocol (i.e. available for follow-up visits and specimen collection).
  2. For females of reproductive age, they must not be pregnant (as determined by verbal screening).
  3. Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
  4. Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator

Exclusion Criteria:

  1. Ongoing serious chronic disease
  2. Immunocompromising condition or therapy
  3. Diarrhea (3 or more loose/more watery stools within a 24-hour period) 6 weeks prior to enrollment
  4. One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
  5. One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
  6. Intake of any anti-diarrhea medicine in the past week
  7. Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
  8. Acute disease one week prior to enrollment, with or without fever. Temperature ≥38ºC (oral) or axillary temperature ≥ 37.5ºC warrants deferral of the vaccination pending recovery of the subject
  9. Receipt of antibiotics in past 14 days
  10. Receipt of live or killed enteric vaccine in past 4 weeks
  11. Receipt of killed oral cholera vaccine
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760825

Christian Medical College
Vellore, Tamil Nadu, India, 632 002
Sponsors and Collaborators
International Vaccine Institute
Shantha Biotechnics Limited
Christian Medical College, Vellore, India
Principal Investigator: Venkata R Mohan, M.D., MPH Christian Medical College, Vellore, India
More Information

Additional Information:
Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00760825     History of Changes
Other Study ID Numbers: CH-WC-02
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: June 17, 2014
Last Verified: June 2014

Keywords provided by International Vaccine Institute:
oral cholera vaccine

Additional relevant MeSH terms:
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs