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Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

NCT ID: NCT00125008

Last Updated: 2008-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37673 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Typhoid Paratyphoid Fever

Keywords

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Salmonella Typhoid vaccine enteric fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Typhoid Vi vaccine

Group Type EXPERIMENTAL

Typhoid Vi vaccine

Intervention Type BIOLOGICAL

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

2

Hepatitis A vaccine

Group Type ACTIVE_COMPARATOR

Hepatitis A vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Typhoid Vi vaccine

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

Intervention Type 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

Intervention Type BIOLOGICAL

Other Intervention Names

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Typherix Havrix

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Cholera and Enteric Diseases, India

OTHER

Sponsor Role collaborator

Wellcome Trust

OTHER

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

International Vaccine Institute

OTHER

Sponsor Role lead

Responsible Party

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International Vaccine Institute

Principal Investigators

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Sujit K Bhatttacharya, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cholera and Enteric Diseases, India

Locations

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National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Site Status

Countries

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India

References

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Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.

Reference Type BACKGROUND
PMID: 15609776 (View on PubMed)

Dutta S, Sur D, Manna B, Bhattacharya SK, Deen JL, Clemens JD. Rollback of Salmonella enterica serotype Typhi resistance to chloramphenicol and other antimicrobials in Kolkata, India. Antimicrob Agents Chemother. 2005 Apr;49(4):1662-3. doi: 10.1128/AAC.49.4.1662-1663.2005. No abstract available.

Reference Type BACKGROUND
PMID: 15793167 (View on PubMed)

Sur D, Ochiai RL, Bhattacharya SK, Ganguly NK, Ali M, Manna B, Dutta S, Donner A, Kanungo S, Park JK, Puri MK, Kim DR, Dutta D, Bhaduri B, Acosta CJ, Clemens JD. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med. 2009 Jul 23;361(4):335-44. doi: 10.1056/NEJMoa0807521.

Reference Type DERIVED
PMID: 19625715 (View on PubMed)

Other Identifiers

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T-17

Identifier Type: -

Identifier Source: org_study_id