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

Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam. An Evaluation of Feasibility, Public Acceptability, Effectiveness and Cost-Effectiveness in Students

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.

Study Overview

• Status: Completed
• Conditions: Typhoid; Paratyphoid Fever
• Intervention / Treatment: Biological: Typhoid Vi vaccine; Biological: Hepatitis A (control)

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 Type: Interventional
• Enrollment: 100742
• Phase: Phase 4

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • National Institute of Hygiene and Epidemiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Adverse events
Cost-effectiveness of vaccine
Vaccine effectiveness
Typhoid risk factors

Collaborators and Investigators

• Sponsor: International Vaccine Institute
• Collaborators: GlaxoSmithKline; Wellcome Trust; National Institute of Hygiene and Epidemiology, Vietnam; University of Western Ontario, Canada; Hue Preventive Medicine Center, Vietnam
• Investigators: Principal Investigator: Canh G Do, MD, National Institute of Hygiene and Epidemiology, Vietnam

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: August 18, 2005
• First Submitted That Met QC Criteria: August 18, 2005
• First Posted (Estimate): August 19, 2005

Study Record Updates

• Last Update Posted (Estimate): March 13, 2008
• Last Update Submitted That Met QC Criteria: March 10, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Salmonella; enteric fever; typhoid vaccine; socioeconomic costs
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Salmonella Infections; Typhoid Fever; Paratyphoid Fever
• Other Study ID Numbers: T-14