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
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
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE4
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
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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
- Aga Khan University
- GlaxoSmithKline
- International Vaccine Institute
- University of Western Ontario, Canada
- Wellcome Trust
For direct contact, visit the study record on ClinicalTrials.gov .