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| Name | Class |
|---|---|
| Department of Health and Family Welfare, Orissa | OTHER |
| Indian Council of Medical Research | OTHER_GOV |
| National Institute of Cholera and Enteric Diseases, India | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Consenting, eligible participants | All consenting eligible participants in the study area will receive the oral cholera vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Shantanu K Kar, MD | Director, Regional Medical Research Center, Bhubaneswar, Orissa, India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Medical Research Center | Chandrashekharpur, Bhubaneswar | Odisha | 751023 | India |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Shantha Biotechnics Limited |
| INDUSTRY |
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| For a thirty days starting from the 30 days following the last dose of vaccination |
| D007239 | Infections |