Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131820
Enrollment
100742
Registered
2005-08-19
Start date
2001-12-31
Completion date
2007-01-31
Last updated
2008-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paratyphoid Fever, Typhoid

Keywords

Salmonella, typhoid vaccine, enteric fever, socioeconomic costs

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.

Interventions

BIOLOGICALHepatitis A (control)

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam
CollaboratorOTHER
Hue Preventive Medicine Center, Vietnam
CollaboratorUNKNOWN
Wellcome Trust
CollaboratorOTHER
University of Western Ontario, Canada
CollaboratorOTHER
GlaxoSmithKline
CollaboratorINDUSTRY
International Vaccine Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
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

Exclusion criteria

* Fever (\>37.5 degrees Celsius, axillary) * Pregnancy * Lactating

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Cost-effectiveness of vaccine
Vaccine effectiveness
Adverse events
Typhoid risk factors

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026