MedTrace Logo

Safety and Immunogenicity of Oral Cholera Vaccine in Kolkata

NCT00119197 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2008-07-04

No results posted yet for this study

Summary

The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.

Conditions

  • Cholera

Interventions

BIOLOGICAL

killed whole cell oral cholera vaccine

Bivalent oral killed cholera vaccine: each dose of this vaccine contains: * Inactivated V.Cholerae Inaba (569B), Classical biotype - 25.109 cells * Inactivated V.Cholerae Ogawa (Cairo 50) Classical biotype - 25.109 cells * Inactivated V.Cholerae Inaba (Phil 6973) El Tor biotype - 50.109 cells * Inactivated V.Cholerae O139 - 50.109 cells each 1.5 mL dose given orally, two doses given 14 days apart

BIOLOGICAL

Heat Killed E. coli

Escherichia coli K12 strain placebo: each dose of placebo contains heat-killed E. coli K12 strain in an amount whose optical turbidity is identical to that for the cholera vaccine. Each 1.5 mL dose given orally, two doses given 14 days apart

Sponsors & Collaborators

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Sujit K Bhatttacharya, MD · National Institute of Cholera and Enteric Diseases, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-06-30
Completion
2006-07-31

Countries

  • India

Study Locations

More Related Trials

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 NCT00119197 on ClinicalTrials.gov