Brief Title
Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
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
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Total protection against S. typhi
Secondary Outcome
Indirect protection against s. typhi
Condition
Typhoid
Intervention
Typhoid Vi vaccine
Study Arms / Comparison Groups
1
Description: Typhoid Vi polysaccharide vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
27231
Start Date
October 2001
Completion Date
August 2007
Primary Completion Date
August 2007
Eligibility Criteria
Inclusion Criteria: - Registered in the project census - Age: 2-16 years Exclusion Criteria: - Fever >37.5 degrees Celsius, axillary - Pregnancy - Lactating
Gender
All
Ages
2 Years - 16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Zulfiqar A Bhutta, MBBS, PhD, ,
Location Countries
Pakistan
Location Countries
Pakistan
Administrative Informations
NCT ID
NCT00125047
Organization ID
T-7
Study Sponsor
International Vaccine Institute
Collaborators
Aga Khan University
Study Sponsor
Zulfiqar A Bhutta, MBBS, PhD, Principal Investigator, Aga Khan University
Verification Date
August 2008