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Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

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ClinicalTrials.gov Identifier: NCT00125008
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : August 26, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Typhoid Paratyphoid Fever Biological: Typhoid Vi vaccine Biological: Hepatitis A vaccine Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37673 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata, West Bengal, India
Study Start Date : May 2003
Primary Completion Date : January 2008
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Hepatitis A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Typhoid Vi vaccine
Biological: Typhoid Vi vaccine
single 0.5ml dose (25ug of purified Vi polysaccharide of S. typhi)
Other Name: Typherix
Active Comparator: 2
Hepatitis A vaccine
Biological: Hepatitis A vaccine
720 EL.U. of inactivated hepatitis A viral antigen for children 1440 EL.U. of inactivated hepatitis A viral antigen for adults
Other Name: Havrix


Outcome Measures

Primary Outcome Measures :
  1. Total protection against S. typhi [ Time Frame: 2 years from zero time ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00125008


Locations
India
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India
Sponsors and Collaborators
International Vaccine Institute
National Institute of Cholera and Enteric Diseases, India
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Investigators
Principal Investigator: Sujit K Bhatttacharya, MD National Institute of Cholera and Enteric Diseases, India
More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr. Leon Ochiai, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00125008     History of Changes
Other Study ID Numbers: T-17
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by International Vaccine Institute:
Salmonella
Typhoid vaccine
enteric fever

Additional relevant MeSH terms:
Typhoid Fever
Fever
Paratyphoid Fever
Body Temperature Changes
Signs and Symptoms
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs