Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

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Brief Title

Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

Official Title

Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India

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 Kolkata, India. The
      cost-effectiveness of the 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 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.
    

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 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

37673

Start Date

May 2003

Completion Date

January 2008

Primary Completion Date

January 2008

Eligibility Criteria

        Inclusion Criteria:

          -  Registered in the project census

          -  Age >=2 years

          -  Provide informed consent to receive vaccine

        Exclusion Criteria:

          -  Fever (>37.5 degrees Celsius)

          -  Pregnancy

          -  Lactating
      

Gender

All

Ages

2 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sujit K Bhatttacharya, MD, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT00125008

Organization ID

T-17



Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Cholera and Enteric Diseases, India

Study Sponsor

Sujit K Bhatttacharya, MD, Principal Investigator, National Institute of Cholera and Enteric Diseases, India


Verification Date

August 2008