Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

August 25, 2008 updated by: International Vaccine Institute

Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs since it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements.

This project attempts to evaluate a new vaccination strategy for residents of endemic areas. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (Hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 contiguous urban wards in Kolkata. The vaccines used in this study are internationally produced and locally licensed. A 1 year pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever cases will continue after the mass immunization campaign. A passive surveillance system to evaluate adverse events following immunization will be implemented. Socio-economic studies will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also be determined.

Study Type

Interventional

Enrollment (Actual)

37673

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Kolkata, West Bengal, India
        • National Institute of Cholera and Enteric Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Registered in the project census
  • Age >=2 years
  • Provide informed consent to receive vaccine

Exclusion Criteria:

  • Fever (>37.5 degrees Celsius)
  • Pregnancy
  • Lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Typhoid Vi vaccine
Biological: Typhoid Vi vaccine
single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)
Other Names:
  • Typherix
Active Comparator: 2
Hepatitis A vaccine
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
Other Names:
  • Havrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total protection against S. typhi
Time Frame: 2 years from zero time
2 years from zero time

Secondary Outcome Measures

Outcome Measure
Time Frame
Indirect protection against S. typhi
Time Frame: 2 years from zero time
2 years from zero time
Overall protection against S. typhi
Time Frame: 2 years from zero time
2 years from zero time
Total protection against S. paratyphi
Time Frame: 2 years from zero time
2 years from zero time
Adverse event(s) following immunization
Time Frame: 30 days from vaccination
30 days from vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Collaborators

GlaxoSmithKline
Wellcome Trust
University of Western Ontario, Canada
National Institute of Cholera and Enteric Diseases, India

Investigators

  • Principal Investigator: Sujit K Bhatttacharya, MD, National Institute of Cholera and Enteric Diseases, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

July 28, 2005

First Submitted That Met QC Criteria

July 28, 2005

First Posted (Estimate)

July 29, 2005

Study Record Updates

Last Update Posted (Estimate)

August 26, 2008

Last Update Submitted That Met QC Criteria

August 25, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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