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Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

NCT00419133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-12-07

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.

Conditions

Interventions

BIOLOGICAL

Killed bivalent whole cell oral cholera vaccine

Each 1.5 mL dose, given orally, 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

Heat Killed E. coli Placebo

Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.

Sponsors & Collaborators

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • India

Study Locations

More Related Trials

Entities

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 NCT00419133 on ClinicalTrials.gov