Effectiveness of Rotavirus Immunization in Nicaragua

NCT ID: NCT01133808

Last Updated: 2011-09-09

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

Total Enrollment

667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era.

Detailed Description

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Conditions

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Diarrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua

Exclusion Criteria

* Parents do not consent to child's participation
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Thrasher Research Fund

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Sylvia Becker-Dreps

OTHER

Sponsor Role lead

Responsible Party

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Sylvia Becker-Dreps

Assistant Professor, Department of Family Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sylvia Becker-Dreps, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Other Identifiers

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K01TW008401-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

09-0371

Identifier Type: -

Identifier Source: org_study_id

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