Pilot Introduction of Oral Cholera Vaccine in Orissa, India

This study has been completed.
Sponsor:
Collaborators:
Department of Health and Family Welfare, Orissa
Indian Council of Medical Research, India
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Information provided by (Responsible Party):
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT01365442
First received: March 10, 2010
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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
Cholera

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Official Title: Pilot Introduction of the Modified Bivalent Killed Whole Cell Oral Cholera Vaccine in Orissa

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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.


Enrollment: 31552
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Consenting, eligible participants
All consenting eligible participants in the study area will receive the oral cholera vaccine

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.

  Eligibility

Ages Eligible for Study:   12 Months and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365442

Locations
India
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, India
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Investigators
Principal Investigator: Shantanu K Kar, MD Director, Regional Medical Research Center, Bhubaneswar, Orissa, India
  More Information

No publications provided

Responsible Party: International Vaccine Institute
ClinicalTrials.gov Identifier: NCT01365442     History of Changes
Other Study ID Numbers: CR-WC-03
Study First Received: March 10, 2010
Last Updated: May 21, 2013
Health Authority: India: Drugs Controller General of India

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

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014