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

Sponsor

International Vaccine Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00131820

Collaborator

National Institute of Hygiene and Epidemiology, Vietnam (Other), Hue Preventive Medicine Center, Vietnam (Other), Wellcome Trust (Other), University of Western Ontario, Canada (Other), GlaxoSmithKline (Industry)

100,742

Enrollment

Location

Duration (Months)

1651.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Typhoid Paratyphoid Fever	Biological: Typhoid Vi vaccine Biological: Hepatitis A (control)	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 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

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

Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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