Status:
COMPLETED
Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
National Institute of Cholera and Enteric Diseases, India
Indian Council of Medical Research
Conditions:
Cholera
Eligibility:
All Genders
12-40 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.
Detailed Description
Cholera remains to be a serious public health problem worldwide. In the mid-1980s following technology transfer from Sweden, Vietnamese scientists developed and produced an oral killed monovalent chol...
Eligibility Criteria
Inclusion
- Healthy non-pregnant adults aged 18-40 years and children aged 1-17 years
Exclusion
- Diarrhea during the past week
- Antibiotic and anti-diarrheal medicine use during the past week
- One or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months
- Abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours
- Pregnancy
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00119197
Start Date
August 1 2005
End Date
July 1 2006
Last Update
July 4 2008
Active Locations (1)
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1
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India