Viewing Study NCT00386789



Ignite Creation Date: 2024-05-05 @ 5:05 PM
Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00386789
Status: COMPLETED
Last Update Posted: 2017-07-02
First Post: 2006-10-11

Brief Title: Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age
Status: COMPLETED
Status Verified Date: 2008-06-17
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: Typhoid fever remains an important cause of morbidity and mortality in the developing world It is estimated that more than 16 million cases and about 600000 deaths occur annually most of which occur in Southeast Asia and Africa Ingestion of food or water contaminated by acutely infected persons or chronic carriers is the most common form of transmission As a result typhoid fever is prevalent where unsafe drinking water or contaminated food is common

Typhoid fever is highly endemic in Vietnam especially in the southern provinces and is a significant disease in both preschool and school-aged children Data from Dong Thap Provincial Hospital Mekong delta region showed that among 3934 hospitalized typhoid fever cases from 1990 to 1995 42 had complications and 08 died

Typhoid fever has become difficult and expensive to treat About 90 of Salmonella typhi isolates are of multidrug-resistant resistant to chloramphenicol ampicillin and trimethoprim-sulfamethoxazole and 76 of isolates showed reduced susceptibility to fluoroquinolones Isolates with full fluoroquinolone or extended spectrum cephalosporin resistance have not yet reported in Vietnam but occur sporadically in the Indian subcontinent If they become widespread alternative treatment options will be limited The improvement of sanitation provision of safe water and elimination of chronic carriage is not expected to be achieved quickly Accordingly vaccination against typhoid fever is increasingly important national public health priority
Detailed Description: Typhoid fever remains an important cause of morbidity and mortality in the developing world It is estimated that more than 16 million cases and about 600000 deaths occur annually most of which occur in Southeast Asia and Africa Ingestion of food or water contaminated by acutely infected persons or chronic carriers is the most common form of transmission As a result typhoid fever is prevalent where unsafe drinking water or contaminated food is common

Typhoid fever is highly endemic in Vietnam especially in the southern provinces and is a significant disease in both preschool and school-aged children Data from Dong Thap Provincial Hospital Mekong delta region showed that among 3934 hospitalized typhoid fever cases from 1990 to 1995 42 had complications and 08 died

Typhoid fever has become difficult and expensive to treat About 90 of Salmonella typhi isolates are of multidrug-resistance resistant to chloramphenicol ampicillin and trimethoprim-sulfamethoxazole and 76 of isolates showed reduced susceptibility to fluoroquinolones Isolates with full fluoroquinolone or extended spectrum cephalosporin resistance have not been reported yet in Vietnam but occur sporadically in the Indian subcontinent If they become widespread alternative treatment options will be limited The improvement of sanitation provision of safe water and elimination of chronic carriage are not expected to be achieved quickly Accordingly vaccination against typhoid fever is an increasingly important national public health priority

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
Secondary IDs
Secondary ID Type Domain Link
07-CH-N004 None None None