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Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

NCT00125008 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37673

Last updated 2008-08-26

No results posted yet for this study

Summary

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Conditions

  • Typhoid
  • Paratyphoid Fever

Interventions

BIOLOGICAL

Typhoid Vi vaccine

single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)

BIOLOGICAL

Hepatitis A vaccine

720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults

Sponsors & Collaborators

  • National Institute of Cholera and Enteric Diseases, India

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • University of Western Ontario, Canada

    collaborator OTHER

  • GlaxoSmithKline

    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
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • India

Study Locations

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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 NCT00125008 on ClinicalTrials.gov