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Effectiveness of Rotavirus Immunization in Nicaragua

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01133808
First Posted: May 31, 2010
Last Update Posted: September 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Merck Sharp & Dohme Corp.
Thrasher Research Fund
John E. Fogarty International Center (FIC)
Information provided by (Responsible Party):
Sylvia Becker-Dreps, University of North Carolina, Chapel Hill
  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:


Further study details as provided by Sylvia Becker-Dreps, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133808


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

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 ( U.S. NIH Grant/Contract )
First Submitted: May 27, 2010
First Posted: May 31, 2010
Last Update Posted: September 9, 2011
Last Verified: September 2011

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Vaccines
Immunologic Factors
Physiological Effects of Drugs