Pilot Introduction of Oral Cholera Vaccine in Orissa, India
|ClinicalTrials.gov Identifier: NCT01365442|
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : May 23, 2013
|Condition or disease|
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:
- As the modified WC vaccine is safe, effective, and cost-effective, it was suggested that the National Technical Advisory Group on Immunization (NTAGI) should consider recommending introduction of the vaccine in public health programs targeted to appropriate populations in India.
- Vaccination should be initiated in selected highly endemic and/or slum areas such as known areas in West Bengal or Orissa. The pilot vaccination programs will be monitored and evaluated. Further expansion to other areas and wider policy changes will be made in a step-by-step fashion based on the pilot programs. Logistical and operational issues need to be defined.
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.
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.
To identify challenges to mass oral cholera vaccine implementation.
|Study Type :||Observational|
|Actual Enrollment :||31552 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||September 2012|
Consenting, eligible participants
All consenting eligible participants in the study area will receive the oral cholera vaccine
- To determine the feasibility [ 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. ]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.
- Assessment of acceptability and costs of vaccination program [ Time Frame: For a thirty days starting from the 30 days following the last dose of vaccination ]
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
- vaccine coverage rate
- survey results which will be qualtitaviely and quantitatively summarized by the sociobehavioral scientists based on in-person interviews.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365442
|Regional Medical Research Center|
|Chandrashekharpur, Bhubaneswar, Orissa, India, 751023|
|Principal Investigator:||Shantanu K Kar, MD||Director, Regional Medical Research Center, Bhubaneswar, Orissa, India|