Pilot Introduction of Oral Cholera Vaccine in Orissa, India

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Brief Title

Pilot Introduction of Oral Cholera Vaccine in Orissa, India

Official Title

Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa

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.
    


Study Type

Observational


Primary Outcome

To determine the feasibility

Secondary Outcome

 Assessment of acceptability and costs of vaccination program

Condition

Cholera


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

31552

Start Date

May 2011

Completion Date

September 2012

Primary Completion Date

March 2012

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
      

Gender

All

Ages

12 Months - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Shantanu K Kar, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01365442

Organization ID

CR-WC-03


Responsible Party

Sponsor

Study Sponsor

International Vaccine Institute

Collaborators

 Department of Health and Family Welfare, Orissa

Study Sponsor

Shantanu K Kar, MD, Principal Investigator, Director, Regional Medical Research Center, Bhubaneswar, Orissa, India


Verification Date

May 2013