Status:
COMPLETED
Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Conditions:
Diarrhea
Cholera
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in In...
Detailed Description
Cholera remains a serious public health problem worldwide. Provision of safe water and food, establishment of adequate sanitation, and implementation of personal and community hygiene constitute the m...
Eligibility Criteria
Inclusion
- All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area
Exclusion
- individuals who are too weak to get out of bed to receive the vaccine;
- pregnant women (identified through verbal screening); and
- those less than 1 year of age
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
69329 Patients enrolled
Trial Details
Trial ID
NCT00289224
Start Date
July 1 2006
End Date
May 1 2013
Last Update
July 31 2014
Active Locations (1)
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1
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India