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Completed

NCT Number: NCT00125008

Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Typhoid Vi vaccine

Biological

single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)

Other names: Typherix

Hepatitis A Vaccine

Biological

720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults

Other names: Havrix

Primary outcomes

  1. Total protection against S. typhi

    Time frame: 2 years from zero time

Secondary outcomes

  1. Indirect protection against S. typhi

    Time frame: 2 years from zero time

  2. Overall protection against S. typhi

    Time frame: 2 years from zero time

  3. Total protection against S. paratyphi

    Time frame: 2 years from zero time

  4. Adverse event(s) following immunization

    Time frame: 30 days from vaccination

Sponsors and collaborators

Lead sponsor

International Vaccine Institute

Other

Collaborators

  • GlaxoSmithKline
  • National Institute of Cholera and Enteric Diseases, India
  • University of Western Ontario, Canada
  • Wellcome Trust

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 29, 2005
Registry last updated
Aug 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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