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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2005

Last Updated Date

March 10, 2008

Start Date ^†

December 2001

Current 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

Original 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

Change History

Complete list of historical versions of study NCT00131820 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Cost-effectiveness of vaccine
Vaccine effectivenes
Adverse events
Typhoid risk factors

Descriptive Information

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

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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study

Condition ^†

Typhoid
Paratyphoid Fever

Intervention ^†

Biological: Typhoid Vi vaccine
Biological: Hepatitis A (control)

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

100742

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

5 Years to 18 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Vietnam

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00131820

Responsible Party

Mr. Leon Ochiai, International Vaccine Institute

Secondary IDs ^††

Study Sponsor ^†

International Vaccine Institute

Collaborators ^††

National Institute of Hygiene and Epidemiology, Vietnam
Hue Preventive Medicine Center, Vietnam
The Center for Tropical Diseases, Wellcome trust
University of Western Ontario, Canada
GlaxoSmithKline

Investigators ^†

Principal Investigator:

Canh G Do, MD

National Institute of Hygiene and Epidemiology, Vietnam

Information Provided By

International Vaccine Institute

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.