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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Hue Preventive Medicine Center, Vietnam
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00131820
First received: August 18, 2005
Last updated: March 10, 2008
Last verified: March 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Typhoid
Paratyphoid Fever
 Biological: Typhoid Vi vaccine
Biological: Hepatitis A (control)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • Logistic feasibility of mass typhoid immunization campaign
  • Knowledge attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment

Secondary Outcome Measures:
  • Cost-effectiveness of vaccine
  • Vaccine effectiveness
  • Adverse events
  • Typhoid risk factors

Estimated Enrollment: 100742
Study Start Date: December 2001
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131820

Locations
Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam
Sponsors and Collaborators
International Vaccine Institute
National Institute of Hygiene and Epidemiology, Vietnam
Hue Preventive Medicine Center, Vietnam
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Investigators
Principal Investigator: Canh G Do, MD National Institute of Hygiene and Epidemiology, Vietnam
  More Information

Publications:

Responsible Party: Mr. Leon Ochiai, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00131820     History of Changes
Other Study ID Numbers: T-14
Study First Received: August 18, 2005
Last Updated: March 10, 2008
Health Authority: Vietnam: Ministry of Health

Keywords provided by International Vaccine Institute:
Salmonella
typhoid vaccine
enteric fever
socioeconomic costs

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 May 22, 2013