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Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

NCT00289224 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 69329

Last updated 2014-07-31

No results posted yet for this study

Summary

The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.

Conditions

Interventions

BIOLOGICAL

bivalent killed whole cell oral cholera vaccine

Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains: V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

BIOLOGICAL

Placebo

Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.

Sponsors & Collaborators

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Dipika Sur, MD · National Institute of Cholera and Enteric Diseases, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2011-12-31
Completion
2013-05-31

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

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 NCT00289224 on ClinicalTrials.gov