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

Sponsors and Collaborators:	International Vaccine Institute 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
Information provided by:	International Vaccine Institute
ClinicalTrials.gov Identifier:	NCT00131820

Purpose

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	Intervention	Phase
Typhoid Paratyphoid Fever	Biological: Typhoid Vi vaccine Biological: Hepatitis A (control)	Phase IV

MedlinePlus related topics: Childhood Immunization Fever

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by International Vaccine Institute:

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

Estimated Enrollment:	100742
Study Start Date:	December 2001
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131820

Locations

Vietnam
National Institute of Hygiene and Epidemiology
Hanoi, Vietnam

Sponsors and Collaborators

International Vaccine Institute

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

More Information

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.

Responsible Party:	International Vaccine Institute ( Mr. Leon Ochiai )
Study ID Numbers:	T-14
Study First Received:	August 18, 2005
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00131820
Health Authority:	Vietnam: Ministry of Health

Keywords provided by International Vaccine Institute:

Salmonella
typhoid vaccine
enteric fever
socioeconomic costs

Study placed in the following topic categories:

Bacterial Infections
Fever
Enterobacteriaceae Infections
Salmonella Infections
Typhoid

Typhoid fever
Typhoid Fever
Paratyphoid Fever
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on January 16, 2009