NCT01365442

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

10 months

First QC Date

March 10, 2010

Last Update Submit

May 21, 2013

Conditions

Cholera

Keywords

CholeraVaccinationOral cholera vaccineMass vaccinationOral whole cell cholera vaccine

Outcome Measures

Primary Outcomes (1)

  • To determine the feasibility

    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.

    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.

Secondary Outcomes (1)

  • Assessment of acceptability and costs of vaccination program

    For a thirty days starting from the 30 days following the last dose of vaccination

Study Arms (1)

Consenting, eligible participants

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

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • aged 12 months and older
  • non-pregnant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regional Medical Research Center

Chandrashekharpur, Bhubaneswar, Odisha, 751023, India

Location

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Shantanu K Kar, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2010

First Posted

June 3, 2011

Study Start

May 1, 2011

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

IN(1)