Pilot Introduction of Oral Cholera Vaccine in Orissa, India

NCT ID: NCT01365442

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31552 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-09-30

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).

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.

Conditions

Cholera

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY

Study Groups

Consenting, eligible participants

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Family Welfare, Orissa

OTHER

Sponsor Role: collaborator

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

National Institute of Cholera and Enteric Diseases, India

OTHER

Sponsor Role: collaborator

Shantha Biotechnics Limited

INDUSTRY

Sponsor Role: collaborator

International Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shantanu K Kar, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Regional Medical Research Center, Bhubaneswar, Orissa, India

Locations

Regional Medical Research Center

Chandrashekharpur, Bhubaneswar, Odisha, India

Countries

India

Other Identifiers

CR-WC-03

Identifier Type: -

Identifier Source: org_study_id