Pilot Introduction of Oral Cholera Vaccine in Orissa, India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365442
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : May 23, 2013
Department of Health and Family Welfare, Orissa
Indian Council of Medical Research
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Information provided by (Responsible Party):
International Vaccine Institute

Brief Summary:
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).

Condition or disease

Detailed Description:

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.

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.

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cholera
U.S. FDA Resources

Consenting, eligible participants
All consenting eligible participants in the study area will receive the oral cholera vaccine

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

    1. vaccine coverage rate
    2. survey results which will be qualtitaviely and quantitatively summarized by the sociobehavioral scientists based on in-person interviews.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in ~100 selected villages with approximate population of 50,000 in Satyabadi block of Puri district, Orissa

Inclusion Criteria:

  • aged 12 months and older
  • non-pregnant

Exclusion Criteria:

  • age less than 12 months
  • pregnant
  • too ill/old to get out of bed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365442

Regional Medical Research Center
Chandrashekharpur, Bhubaneswar, Orissa, India, 751023
Sponsors and Collaborators
International Vaccine Institute
Department of Health and Family Welfare, Orissa
Indian Council of Medical Research
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Principal Investigator: Shantanu K Kar, MD Director, Regional Medical Research Center, Bhubaneswar, Orissa, India

Responsible Party: International Vaccine Institute Identifier: NCT01365442     History of Changes
Other Study ID Numbers: CR-WC-03
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by International Vaccine Institute:
Oral cholera vaccine
Mass vaccination
Oral whole cell cholera vaccine

Additional relevant MeSH terms:
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs