Status:
UNKNOWN
Effectiveness of a Bivalent Killed Whole Cell Based Oral Cholera Vaccine
Lead Sponsor:
International Vaccine Institute
Collaborating Sponsors:
Department of Health and Family Welfare, Orissa
Regional Medical Research Center, Orissa
Conditions:
Cholera
Eligibility:
All Genders
1+ years
Brief Summary
Various field studies has found that the modified , bivalent, whole cell - based oral cholera vaccine (OCV) to be safe, immunogenic and effective with protective efficacy of 67 % in earlier clinical t...
Detailed Description
The overall goal of this study is to evaluate the protective effectiveness of one or two doses of modified, bivalent, killed whole cell based OCV, given at least 14 days apart, when delivered through ...
Eligibility Criteria
Inclusion
- Inclusion criteria for cases of the main case-control study are as follows:
- Giving verbal informed consent/assent, or in the case of minors, a parent or guardian give informed consent to participate in the study
- Living in the study area since the start of the mass vaccination
- Submitted a faecal specimen
- Whose residence could be located
- Whose stool specimens yield V. cholera O1 or O139
- Belonging to study population through census database
- Exclusion criteria:
- Not giving verbal informed consent/assent, or in the case of minors, a parent or guardian does not give informed consent to participate in the study
- Not living in the study area since the start of the mass vaccination
- No faecal specimen
- Whose residence could not be located
- Whose stool specimens does not yield V. cholera O1 or O139
- Not belonging to study population through census database
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01508507
Start Date
March 1 2013
End Date
March 1 2014
Last Update
June 5 2013
Active Locations (1)
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1
Regional Medical Research Center
Chandrashekharpur, Bhubaneswar, Odisha, India, 751016