BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study) (BEAR)
Study Overview
The primary objectives of the study are: To estimate the effectiveness of nirsevimab against polymerase chain reaction (PCR)-confirmed RSV (1) lower respiratory tract (LRTD) and (2) related medical encounters.
the secondary objectives are:
- To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
- To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
- To estimate the impact of nirsevimab on PCR-confirmed RSV.
- To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
- To estimate the impact of nirsevimab on antibiotic prescription.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
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Conditions:
Respiratory Syncytial Virus
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Age: - 12 Months
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Gender: All
Inclusion Criteria:
- The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01 April 2023 for Cohort 1 and Cohort 2.
- Eligible to receive nirsevimab as defined by the product indication.
- KPNC infants entering their first RSV season.
Exclusion Criteria:
- Mother was administered an RSV vaccine during her pregnancy with the infant participant.
- Mother of infant participant was not a KPNC member during pregnancy.
- Mother did not deliver the infant participant at a KPNC facility.
- Infant receipt of other RSV pre-exposure prophylaxis (ie, Palivizumab).
Note: The above information is not intended to contain all considerations relevant to a
potential participation in a clinical trial.
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