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Completed

NCT Number: NCT01365442

Pilot Introduction of Oral Cholera Vaccine in Orissa, India

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).

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Key information

Conditions

Cholera Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

12 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regional Medical Research Center

Chandrashekharpur, Bhubaneswar, Odisha, 751023, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

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

Sponsors and collaborators

Lead sponsor

International Vaccine Institute

Other

Collaborators

  • Department of Health and Family Welfare, Orissa
  • Indian Council of Medical Research
  • National Institute of Cholera and Enteric Diseases, India
  • Shantha Biotechnics Limited

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2011
Registry last updated
May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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