deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT00125047

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

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

Sponsor: Aga Khan University

Updated 5 times since 2017 Last updated: Aug 25, 2008 Started: Oct 31, 2001 Primary completion: Aug 31, 2007 Completion: Aug 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Paratyphoid Fever and Typhoid, this trial is completed. The trial is conducted by Aga Khan University and has accumulated 5 data snapshots since 2001. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Oct 2001

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Aga Khan University
  • GlaxoSmithKline
  • International Vaccine Institute
  • University of Western Ontario, Canada
  • Wellcome Trust
Data source: International Vaccine Institute

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations