Effectiveness of Rotavirus Immunization in Nicaragua
2 other identifiers
observational
667
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 27, 2010
CompletedFirst Posted
Study publicly available on registry
May 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedSeptember 9, 2011
September 1, 2011
1 year
May 27, 2010
September 8, 2011
Conditions
Keywords
Eligibility Criteria
Children under age 5 in Leon, Nicaragua
You may not qualify if:
- Parents do not consent to child's participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sylvia Becker-Drepslead
- Merck Sharp & Dohme LLCcollaborator
- Thrasher Research Fundcollaborator
- Fogarty International Center of the National Institute of Healthcollaborator
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvia Becker-Dreps, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor, Department of Family Medicine
Study Record Dates
First Submitted
May 27, 2010
First Posted
May 31, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
September 9, 2011
Record last verified: 2011-09