Trial record 6 of 27 for:    "Typhoid fever"

Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

This study has been completed.
Sponsor:
Collaborators:
National Institute of Cholera and Enteric Diseases, India
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00125008
First received: July 28, 2005
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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 Intervention Phase
Typhoid
Paratyphoid Fever
Biological: Typhoid Vi vaccine
Biological: Hepatitis A vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Total protection against S. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Indirect protection against S. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]
  • Overall protection against S. typhi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]
  • Total protection against S. paratyphi [ Time Frame: 2 years from zero time ] [ Designated as safety issue: No ]
  • Adverse event(s) following immunization [ Time Frame: 30 days from vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 37673
Study Start Date: May 2003
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: July 28, 2005
Last Updated: August 25, 2008
Health Authority: India: Ministry of Health

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

Additional relevant MeSH terms:
Fever
Paratyphoid Fever
Typhoid Fever
Body Temperature Changes
Signs and Symptoms
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 24, 2014