Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
|Typhoid Paratyphoid Fever||Biological: Typhoid Vi vaccine Biological: Hepatitis A vaccine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood: A Demonstration Project in Karachi|
- Total protection against S. typhi [ Time Frame: 2 years from zero time ]
- Indirect protection against s. typhi [ Time Frame: two years from zero time ]
- Overall protection against s. typhi [ Time Frame: 2 years from zero time ]
- Adverse event(s) following immunization [ Time Frame: 30 days from vaccination ]
|Study Start Date:||October 2001|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Typhoid Vi polysaccharide vaccine
Biological: Typhoid Vi vaccine
Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
Other Name: Typherix
Active Comparator: 2
Inactivated Hepatitis A vaccine
Biological: Hepatitis A vaccine
single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
Other Name: Havrix
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125047
|Aga Khan University|
|Principal Investigator:||Zulfiqar A Bhutta, MBBS, PhD||Aga Khan University|