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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Hygiene and Epidemiology, Vietnam
Hue Preventive Medicine Center, Vietnam
Wellcome Trust
University of Western Ontario, Canada
GlaxoSmithKline
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00131820
First received: August 18, 2005
Last updated: March 10, 2008
Last verified: March 2008

August 18, 2005
March 10, 2008
December 2001
January 2007   (final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT00131820 on ClinicalTrials.gov Archive Site
  • Cost-effectiveness of vaccine
  • Vaccine effectiveness
  • Adverse events
  • Typhoid risk factors
  • Cost-effectiveness of vaccine
  • Vaccine effectivenes
  • Adverse events
  • Typhoid risk factors
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Typhoid
  • Paratyphoid Fever
  • Biological: Typhoid Vi vaccine
  • Biological: Hepatitis A (control)
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100742
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT00131820
T-14
Not Provided
Mr. Leon Ochiai, International Vaccine Institute
International Vaccine Institute
  • National Institute of Hygiene and Epidemiology, Vietnam
  • Hue Preventive Medicine Center, Vietnam
  • Wellcome Trust
  • University of Western Ontario, Canada
  • GlaxoSmithKline
Principal Investigator: Canh G Do, MD National Institute of Hygiene and Epidemiology, Vietnam
International Vaccine Institute
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP