Effectiveness of Rotavirus Immunization in Nicaragua
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ClinicalTrials.gov Identifier: NCT01133808
Recruitment Status :
First Posted : May 31, 2010
Last Update Posted : September 9, 2011
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
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.
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.
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Ages Eligible for Study:
up to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children under age 5 in Leon, Nicaragua
Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua