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Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

NCT01524640 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2015-05-04

No results posted yet for this study

Summary

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

Conditions

  • Vibrio Cholerae
  • Cholera

Interventions

BIOLOGICAL

Killed Bivalent (O1 and O139) whole cell oral cholera vaccine

1.5 ml single dose oral administration on day 0 and day 14

BIOLOGICAL

Placebo

1.5 ml oral administration on day 0 and day 14

Sponsors & Collaborators

  • Armauer Hansen Research Institute, Ethiopia

    collaborator OTHER

  • Ministry of Health, Ethiopia

    collaborator OTHER_GOV

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Ethiopia

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Entities

Drugs

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 NCT01524640 on ClinicalTrials.gov