Objective: This article determines the tolerance of neonatal intensive care unit (NICU)-based administration of RV5 in premature infants. This article also aims to compare the rate of clinically significant adverse events after RV5 immunization to the standard 2-month shot series and to historical controls who were not immunized.
Study design: This is a retrospective case-control study of 201 premature infants immunized with RV5. Infants were evaluated for clinically significant events 7 days before and after immunization and were compared with events after the 2-month shot series and to 189 historical controls. Wilcoxon signed rank test and McNemar's test were used for all paired analysis.
Results: There was no increase in number of infants with clinically significant adverse events when comparing after RV5 to prior to RV5, after the 2-month shot series, or to the historical controls.
Conclusion: RV5 is well tolerated in premature infants and does not result in clinically significant adverse events when administered in NICU-hospitalized infants.
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