Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

Study Overview
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Brief Summary
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This study is part of International Vaccine Institute (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 Hechi City in the Guangxhi province of China. The cost-effectiveness and safety of Vi vaccination will also be evaluated.

Detailed Description
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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. 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 (meningococcal A vaccine) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 populous townships of Hechi City. The vaccines used in this study are locally produced and licensed in China. 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. Secondary objectives of this trial are: To estimate the logistic feasibility of a mass typhoid immunization campaign To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention To study typhoid fever risk factors in the population

Official Title
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Typhoid Vi Vaccine Effectiveness in a Population Older Than 5 Years of Age Living in an Endemic Area in Hechi, Guangxi, P.R. China: A Group-Randomized Controlled Demonstration Project

Conditions
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Typhoid, Paratyphoid Fever

Intervention / Treatment
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* Biological: Typhoid Vi vaccine
* Biological: Meningococcal A (control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered in the project census Exclusion Criteria: Pregnant Lactating Fever > 37.5 degrees Celsius, axillary

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Typhoid Vi vaccine|nan|
|Biological: Meningococcal A (control)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccine effectiveness |  |  | 
| cost effectiveness of typhoid Vi immunization |  |  | 
| adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| logistic feasibility of mass typhoid immunization |  |  | 
| anti-Vi antibody response |  |  | 
| knowledge, attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment |  |  | 
| Typhoid risk factors |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salmonella, typhoid vaccine, enteric fever