BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)

Sanofi Pasteur, a Sanofi Company49,680 enrolled

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: 1. To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis. 2. To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis. 3. To estimate the impact of nirsevimab on PCR-confirmed RSV. 4. To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis. 5. To estimate the impact of nirsevimab on antibiotic prescription.

Study Type

OBSERVATIONAL

Enrollment

49,680

Conditions

Respiratory Syncytial Virus

Interventions

NirsevimabOTHER

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)

Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) diagnosis identified using International Classification of Diseases, Tenth Revision (ICD)