Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131820
Status:
COMPLETED
Last Update Posted:
2008-03-13
First Post:
2005-08-18
Brief Title:
Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City Central Vietnam
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is part of International Vaccine Institutes IVIs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None