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Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood

NCT ID: NCT00125047

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

27231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2007-08-31

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 Karachi, Pakistan. The cost-effectiveness of 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 due to the following reasons: 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. 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 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.

Secondary objectives of this trial are:

* To monitor the adverse events following a routine Vi mass vaccination campaign;
* To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
* To study typhoid fever risk factors in the population.

A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.

Conditions

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Typhoid Paratyphoid Fever

Keywords

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Salmonellosis 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 polysaccharide vaccine

Group Type EXPERIMENTAL

Typhoid Vi vaccine

Intervention Type BIOLOGICAL

Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.

2

Inactivated Hepatitis A vaccine

Group Type ACTIVE_COMPARATOR

Hepatitis A vaccine

Intervention Type BIOLOGICAL

single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen

Interventions

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Typhoid Vi vaccine

Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.

Intervention Type BIOLOGICAL

Hepatitis A vaccine

single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen

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: 2-16 years

Exclusion Criteria

* Fever \>37.5 degrees Celsius, axillary
* Pregnancy
* Lactating
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

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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Zulfiqar A Bhutta, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

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Aga Khan University

Karachi, , Pakistan

Site Status

Countries

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Pakistan

References

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Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20. doi: 10.1186/1476-072X-3-20.

Reference Type BACKGROUND
PMID: 15450121 (View on PubMed)

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)

Other Identifiers

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T-7

Identifier Type: -

Identifier Source: org_study_id