An observational study in Cholera, sponsored by International Vaccine Institute. Completed at 1 site in India. Open to participants aged 12 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-23.
Sponsored by International Vaccine Institute · Observational
The purpose of this study is to provide evidence for policymakers and key opinion leaders on the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs and population acceptance of large-scale cholera vaccination using the Indian vaccine (using vaccination coverage rates and other measures).
Severe diarrhoeal disease caused by Vibrio cholerae O1 and O139 has long been an important cause of mortality and morbidity in India. The availability and recent licensure of the modified bivalent killed whole cell OCV in India provides hope that the disease may be controlled in areas where the disease is a problem. On April 10, 2009, a meeting was organized by the Indian Council of Medical Research (ICMR), the Department of Biotechnology and the IVI. The recommendations from the meeting are as follows:
The aim of the study is to conduct a pilot introduction of the modified killed oral cholera vaccine in a public health setting in a population of \~50,000 before implementing in a larger scale.
Primary objective:
To determine the feasibility, acceptability and costs associated with pilot introduction of the modified killed whole cell oral cholera vaccine in India when given in a public health setting.
Secondary objective:
To identify challenges to mass oral cholera vaccine implementation.
74 studies on the registry are indexed under Cholera; 11 are open to participants now.
Browse Cholera studies →International Vaccine Institute is the lead sponsor of 46 studies on the registry; 12 are open to participants now.
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This study will be conducted in \~100 selected villages with approximate population of 50,000 in Satyabadi block of Puri district, Orissa
Exclusion Criteria:
All consenting eligible participants in the study area will receive the oral cholera vaccine
To determine the feasibility
Feasibility will be determined by the vaccine coverage (%), defined as the number of subjects who received the vaccine doses divided by the number of subjects who are targeted for mass vaccination.
Time frame: The numerator (number of people who received the vaccine doses within the target population) will be counted during the 30 days following the last dose of vaccination.
Assessment of acceptability and costs of vaccination program
Costs of vaccination program will be defined as the sum of the cost items required for social mobilization, mass vaccination, and post-vaccination actiities. This includes 1) vaccine price, 2) shipment and insurance costs, 3) personnel(FTEs), 4) supplies including coldboxes and vaccine carriers, 5) transportation. Acceptability will be evaluated by 1. vaccine coverage rate 2. survey results which will be qualtitaviely and quantitatively summarized by the sociobehavioral scientists based on in-person interviews.
Time frame: For a thirty days starting from the 30 days following the last dose of vaccination
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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International Vaccine Institute