Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
Primary Purpose
Typhoid, Paratyphoid Fever
Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
Typhoid Vi vaccine
Hepatitis A (control)
Sponsored by
About this trial
This is an interventional prevention trial for Typhoid focused on measuring Salmonella, typhoid vaccine, enteric fever, socioeconomic costs
Eligibility 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
Sites / Locations
- National Institute of Hygiene and Epidemiology
Outcomes
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
Full Information
NCT ID
NCT00131820
First Posted
August 18, 2005
Last Updated
March 10, 2008
Sponsor
International Vaccine Institute
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam, Hue Preventive Medicine Center, Vietnam, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00131820
Brief Title
Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
International Vaccine Institute
Collaborators
National Institute of Hygiene and Epidemiology, Vietnam, Hue Preventive Medicine Center, Vietnam, Wellcome Trust, University of Western Ontario, Canada, GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typhoid, Paratyphoid Fever
Keywords
Salmonella, typhoid vaccine, enteric fever, socioeconomic costs
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
100742 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Typhoid Vi vaccine
Intervention Type
Biological
Intervention Name(s)
Hepatitis A (control)
Primary Outcome Measure Information:
Title
Logistic feasibility of mass typhoid immunization campaign
Title
Knowledge attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Secondary Outcome Measure Information:
Title
Cost-effectiveness of vaccine
Title
Vaccine effectiveness
Title
Adverse events
Title
Typhoid risk factors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canh G Do, MD
Organizational Affiliation
National Institute of Hygiene and Epidemiology, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Hygiene and Epidemiology
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Citations:
PubMed Identifier
15609776
Citation
Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.
Results Reference
background
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Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam
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