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Clinical Trials/NCT00125047
NCT00125047CompletedPhase 4

Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi

International Vaccine Institute1 site in 1 country27,231 target enrollmentStarted: October 1, 2001Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
27,231
Locations
1
Primary Endpoint
Total protection against S. typhi

Study Overview

Brief 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 Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Registered in the project census
  • •Age: 2-16 years

Exclusion Criteria

  • •Fever >37.5 degrees Celsius, axillary
  • •Pregnancy
  • •Lactating

Arms & Interventions

1

Experimental

Typhoid Vi polysaccharide vaccine

Intervention: Typhoid Vi vaccine (Biological)

2

Active Comparator

Inactivated Hepatitis A vaccine

Intervention: Hepatitis A vaccine (Biological)

Outcomes

Primary Outcomes

Total protection against S. typhi

Time Frame: 2 years from zero time

Secondary Outcomes

  • Indirect protection against s. typhi(two years from zero time)
  • Overall protection against s. typhi(2 years from zero time)
  • Adverse event(s) following immunization(30 days from vaccination)

Investigators

Sponsor Class
Other

Study Sites (1)

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