Typhoid Clinical Trial
Official title:
Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India
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 Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.
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 since 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.
This project attempts to evaluate a new vaccination strategy for residents of endemic areas.
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 2 contiguous urban wards in Kolkata. The
vaccines used in this study are internationally produced and locally licensed. A 1 year
pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever
cases will continue after the mass immunization campaign. A passive surveillance system to
evaluate adverse events following immunization will be implemented. Socio-economic studies
will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes,
beliefs and practices among parents and health care providers regarding typhoid illness,
treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also
be determined.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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