Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

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Brief Title

Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China

Official Title

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

Brief Summary

      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

      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

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

vaccine effectiveness

Secondary Outcome

 logistic feasibility of mass typhoid immunization

Condition

Typhoid

Intervention

Typhoid Vi 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

96468

Start Date

October 2001

Completion Date

November 2006

Primary Completion Date

November 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Registered in the project census

        Exclusion Criteria:

          -  Pregnant

          -  Lactating

          -  Fever > 37.5 degrees Celsius, axillary

Gender

All

Ages

5 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Dong Baiqing, MD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT00131833

Organization ID

T3

Study Sponsor

International Vaccine Institute

Collaborators

 Centers for Disease Control and Prevention

Study Sponsor

Dong Baiqing, MD, Principal Investigator, Guangxi Center for Disease Control and Prevention

Verification Date

March 2008