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

NCT ID: NCT00131820

Last Updated: 2008-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100742 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2007-01-31

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.

Conditions

Typhoid; Paratyphoid Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

Typhoid Vi vaccine

Intervention Type: BIOLOGICAL

Hepatitis A (control)

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

Sponsor Role: collaborator

Hue Preventive Medicine Center, Vietnam

UNKNOWN

Sponsor Role: collaborator

Wellcome Trust

OTHER

Sponsor Role: collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

International Vaccine Institute

OTHER

Sponsor Role: lead

Responsible Party

International Vaccine Institute

Principal Investigators

Canh G Do, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Hygiene and Epidemiology, Vietnam

Locations

National Institute of Hygiene and Epidemiology

Hanoi, , Vietnam

Countries

Vietnam

References

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.

Reference Type: BACKGROUND

PMID: 15609776 (View on PubMed)

Other Identifiers

T-14

Identifier Type: -

Identifier Source: org_study_id