Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125008
Status:
COMPLETED
Last Update Posted:
2008-08-26
First Post:
2005-07-28
Brief Title:
Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever
Sponsor:
International Vaccine Institute
Organization:
International Vaccine Institute
Study Overview
Official Title:
Randomized Controlled Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever in Eastern Kolkata West Bengal India
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 Kolkata India The cost-effectiveness of the 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 since 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
This project attempts to evaluate a new vaccination strategy for residents of endemic areas 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 2 contiguous urban wards in Kolkata The vaccines used in this study are internationally produced and locally licensed A 1 year pilot phase will precede the actual Vi-demonstration project Surveillance for typhoid fever cases will continue after the mass immunization campaign A passive surveillance system to evaluate adverse events following immunization will be implemented Socio-economic studies will be conducted in parallel to the effectiveness evaluation The knowledge attitudes beliefs and practices among parents and health care providers regarding typhoid illness treatment and prevention will be assessed Logistic feasibility and vaccine costs will also be determined
This project attempts to evaluate a new vaccination strategy for residents of endemic areas 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 2 contiguous urban wards in Kolkata The vaccines used in this study are internationally produced and locally licensed A 1 year pilot phase will precede the actual Vi-demonstration project Surveillance for typhoid fever cases will continue after the mass immunization campaign A passive surveillance system to evaluate adverse events following immunization will be implemented Socio-economic studies will be conducted in parallel to the effectiveness evaluation The knowledge attitudes beliefs and practices among parents and health care providers regarding typhoid illness treatment and prevention will be assessed Logistic feasibility and vaccine costs will also be determined
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