NICU RISE (Rotavirus Immunization Safety Evaluation)

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This observational cohort study aims to estimate the rate of transmission of vaccine-strain rotavirus from vaccinated to unvaccinated infants during a one-year period in a U.S. NICU that routinely administers rotavirus vaccine to a large number of infants (>180 annually) who usually remain in the unit for a long period after receipt. The purpose of this study is to show how rotavirus vaccination can be given safely in the NICU setting.

Eligibility & Criteria

IRB #:
20-017898
Official Title:
Collection of stool samples and data from infants in a U.S. neonatal intensive care unit that routinely administers rotavirus vaccine to a large number of infants while in the unit
Study Phase:
Not Applicable
Eligible Age Range:
0 - 12 Months
Gender:
All
Study Categories: