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Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants

NCT00548054 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2015-05-04

No results posted yet for this study

Summary

In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and immunogenicity of the killed oral cholera vaccine among infants less than 1 year of age when given with the expanded program on immunization (EPI) vaccines including diptheria, pertussis and tetanus (DPT), oral polio vaccine (OPV), Hepatitis B vaccines and measles vaccine. Furthermore, the investigators also need to make sure that immune interference does not occur among all the other vaccine antigens given at the same time. Findings from this study will pave the way for the possible use of the killed whole cell oral cholera vaccine (OCV).

Conditions

Interventions

BIOLOGICAL

Bivalent killed oral cholera vaccine

Oral, 1.5 ml, given 2 times at least 14 days apart

BIOLOGICAL

Killed Escherichia coli K12 placebo

oral, 1.5 ml per dose

Sponsors & Collaborators

  • Indian Council of Medical Research

    collaborator OTHER_GOV

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Shantha Biotechnics Limited

    collaborator INDUSTRY

  • Institute of Child Health

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Alok K Deb, PhD, MDDS · National Institute of Cholera and Enteric Disease

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Weeks
Max Age
11 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-08-31
Completion
2016-12-31

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 NCT00548054 on ClinicalTrials.gov