Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

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Brief Title

Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam

Official Title

Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam. An Evaluation of Feasibility, Public Acceptability, Effectiveness and Cost-Effectiveness in Students

Brief Summary

      This study is part of International Vaccine Institutes (IVI)'s typhoid Vi demonstration
      project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic
      countries. The primary objectives of the study are to evaluate the logistic feasibility of a
      mass typhoid fever immunization campaign program targeting school age children in Hue City,
      Vietnam and to assess the knowledge, attitudes, beliefs, and practices of parents and
      healthcare providers in Hue City regarding typhoid fever prevention and treatment.
    

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 logistic
      feasibility of providing Vi vaccine under actual programmatic conditions among school
      students in Hue City. The vaccines used in this study are internationally produced and
      locally licensed.

      Secondary objectives of this trial are:

        -  To estimate the cost-effectiveness (cost of illness, willingness to pay, vaccine
           delivery costs, private vaccine costs, etc) of Vi vaccination

        -  To determine the effectiveness of the Vi polysaccharide vaccine following routine
           administration of a 1-dose schedule to school students (aged >=6 years)

        -  To determine the safety and immunogenicity of the Vi vaccine

        -  To study typhoid risk factors among students

      A nested, prospective matched case-control study is included in the trial in order to study
      typhoid risk factors among children in Hue City.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Logistic feasibility of mass typhoid immunization campaign

Secondary Outcome

 Cost-effectiveness of vaccine

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

100742

Start Date

December 2001

Completion Date

January 2007

Primary Completion Date

January 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Local students whose parents/guardians provide written consent to receive Vi vaccine

          -  Attending any of the 66 registered schools in Hue

          -  Registered in the project census

          -  Lives in Hue City

        Exclusion Criteria:

          -  Fever (>37.5 degrees Celsius, axillary)

          -  Pregnancy

          -  Lactating
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Canh G Do, MD, , 

Location Countries

Vietnam

Location Countries

Vietnam

Administrative Informations


NCT ID

NCT00131820

Organization ID

T-14



Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Hygiene and Epidemiology, Vietnam

Study Sponsor

Canh G Do, MD, Principal Investigator, National Institute of Hygiene and Epidemiology, Vietnam


Verification Date

March 2008