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

Typhoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131820
• Other study ID #: T-14
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2005
• Last updated: March 10, 2008
• Start date: December 2001
• Est. completion date: January 2007

Study information

• Verified date: March 2008
• Source: International Vaccine Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100742
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Paratyphoid Fever
• Typhoid
• Typhoid Fever

Intervention

Biological:
• Typhoid Vi vaccine

• Hepatitis A (control)

Locations

Country	Name	City	State
Vietnam	National Institute of Hygiene and Epidemiology	Hanoi

Sponsors (6)

Lead Sponsor	Collaborator
International Vaccine Institute	GlaxoSmithKline, Hue Preventive Medicine Center, Vietnam, National Institute of Hygiene and Epidemiology, Vietnam, University of Western Ontario, Canada, Wellcome Trust

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Logistic feasibility of mass typhoid immunization campaign
Primary	Knowledge attitudes, beliefs and practices of parents and health care providers on typhoid fever prevention and treatment
Secondary	Cost-effectiveness of vaccine
Secondary	Vaccine effectiveness
Secondary	Adverse events
Secondary	Typhoid risk factors