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

NCT ID: NCT00386789

Last Updated: 2017-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-05

Study Completion Date

2008-06-17

Brief Summary

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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 600,000 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 3,934 hospitalized typhoid fever cases from 1990 to 1995, 4.2% had complications and 0.8% 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

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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 600,000 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 3,934 hospitalized typhoid fever cases from 1990 to 1995, 4.2% had complications and 0.8% 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.

Conditions

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Typhoid Fever

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

Subjects who were involved in the Phase III trial, OH98-CH-N002.

Exclusion Criteria

Not specified.
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Locations

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National Institute of Child Health and Human Development (NICHD), 9000 Rockville

Bethesda, Maryland, United States

Site Status

Dong Thap Provincial Hospital

Dong Thập, , Vietnam

Site Status

National Institute of Hygiene and Epidemiology

Hanoi, , Vietnam

Site Status

Pasteur Institute

Ho Chi Minh City, , Vietnam

Site Status

Countries

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United States Vietnam

References

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Smith MD, Duong NM, Hoa NT, Wain J, Ha HD, Diep TS, Day NP, Hien TT, White NJ. Comparison of ofloxacin and ceftriaxone for short-course treatment of enteric fever. Antimicrob Agents Chemother. 1994 Aug;38(8):1716-20. doi: 10.1128/AAC.38.8.1716.

Reference Type BACKGROUND
PMID: 7986000 (View on PubMed)

Other Identifiers

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07-CH-N004

Identifier Type: -

Identifier Source: secondary_id

999907004

Identifier Type: -

Identifier Source: org_study_id

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