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A Study to Evaluate Safety and Immunogenicity of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Adults and Children

NCT00760825 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-06-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.

Conditions

  • Vibrio Cholerae

Interventions

BIOLOGICAL

killed bivalent (O1 and O139)whole cell oral cholera vaccine

1.5 ml given twice orally, 14 days apart

Sponsors & Collaborators

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Venkata R Mohan, M.D., MPH · Christian Medical College, Vellore, India

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-04-30
Completion
2013-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760825 on ClinicalTrials.gov