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Effectiveness of Rotavirus Immunization in Nicaragua

This study has been completed.
Sponsor:
Collaborators:
Merck
Thrasher Research Fund
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Sylvia Becker-Dreps, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01133808
First received: May 27, 2010
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition
Diarrhea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Biospecimen Retention:   Samples Without DNA

Stool samples obtained from children who develop diarrhea during the course of the study. In addition, stool samples will also be collected from normal children to serve as controls in laboratory analysis.


Enrollment: 667
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children under age 5 in Leon, Nicaragua

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133808

Sponsors and Collaborators
Sylvia Becker-Dreps
Merck
Thrasher Research Fund
John E. Fogarty International Center (FIC)
Investigators
Principal Investigator: Sylvia Becker-Dreps, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Sylvia Becker-Dreps, Assistant Professor, Department of Family Medicine, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01133808     History of Changes
Other Study ID Numbers: 09-0371, K01TW008401-01
Study First Received: May 27, 2010
Last Updated: September 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
diarrhea
childhood
rotavirus
vaccine
Nicaragua

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013