Status:
COMPLETED
A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
Shantha Biotechnics Limited
Christian Medical College, Vellore, India
Conditions:
Vibrio Cholerae
Eligibility:
All Genders
1-40 years
Phase:
PHASE4
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.
Detailed Description
Provision of safe water and food, establishment of adequate sanitation, and implementation of personal and community hygiene constitute the main public health interventions against cholera. These meas...
Eligibility Criteria
Inclusion
- 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).
- For females of reproductive age, they must not be pregnant (as determined by verbal screening).
- Written informed consent obtained from the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
- Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator
Exclusion
- Ongoing serious chronic disease
- Immunocompromising condition or therapy
- Diarrhea (3 or more loose/more watery stools within a 24-hour period) 6 weeks prior to enrollment
- One or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months
- One or two episodes of abdominal pain lasting for more than 2 weeks in the past 6 months
- Intake of any anti-diarrhea medicine in the past week
- Abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours
- 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
- Receipt of antibiotics in past 14 days
- Receipt of live or killed enteric vaccine in past 4 weeks
- Receipt of killed oral cholera vaccine
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00760825
Start Date
March 1 2012
End Date
August 1 2013
Last Update
June 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Christian Medical College
Vellore, Tamil Nadu, India, 632 002