Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125047
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
2005-07-28
Brief Title:
Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
Official Title:
Effectiveness of a Combined Vi Vaccination and Health Education Program on Reducing the Burden of Typhoid During Childhood A Demonstration Project in Karachi
Status:
COMPLETED
Status Verified Date:
2008-08
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 the International Vaccine Institutes IVIs typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Karachi Pakistan The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated
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 effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan The vaccines used in this study are internationally produced and locally licensed A complimentary targeted basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity
Secondary objectives of this trial are
To monitor the adverse events following a routine Vi mass vaccination campaign
To assess the knowledge attitudes beliefs and practices among parents and health care providers regarding typhoid illness treatment and prevention and
To study typhoid fever risk factors in the population
A nested prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi
Secondary objectives of this trial are
To monitor the adverse events following a routine Vi mass vaccination campaign
To assess the knowledge attitudes beliefs and practices among parents and health care providers regarding typhoid illness treatment and prevention and
To study typhoid fever risk factors in the population
A nested prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi
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