Status:
COMPLETED
Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
National Institute of Hygiene and Epidemiology, Vietnam
Göteborg University
Conditions:
Cholera
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among Vietnamese adul...
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
- Available in the study area for 1 month
Exclusion
- Diarrhea for the past week
- Antibiotic use in the past week
- Intake of anti-diarrheal medicines in 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 :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00128011
Start Date
May 1 2005
End Date
June 1 2005
Last Update
November 10 2006
Active Locations (1)
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1
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam, 10000