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Effectiveness of Rotavirus Immunization in Nicaragua

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Thrasher Research Fund
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

May 27, 2010
September 8, 2011
January 2010
January 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01133808 on ClinicalTrials.gov Archive Site
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Effectiveness of Rotavirus Immunization in Nicaragua
Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

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.

Probability Sample

Children under age 5 in Leon, Nicaragua

Diarrhea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
667
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01133808
09-0371, K01TW008401-01
No
Sylvia Becker-Dreps, University of North Carolina, Chapel Hill
Sylvia Becker-Dreps
  • Merck Sharp & Dohme Corp.
  • Thrasher Research Fund
  • John E. Fogarty International Center (FIC)
Principal Investigator: Sylvia Becker-Dreps, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP