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

Sanofi

Status: Enrolling

Conditions: Respiratory Syncytial Virus

Treatments: Other: Nirsevimab

Study type: Observational

Funder types: Industry

Identifiers

NCT06325332

RSV00080

Details and patient eligibility

About

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.

Enrollment: 33,000 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

33,000 participants in 4 patient groups

Cohort 1: Nirsevimab-Exposed Cohort

Description:

Full-term (born ≥ 37 weeks gestational age) infants born on or after 01 April 2023, without a high-risk condition, who receive nirsevimab before or during their first RSV season per recommendations, ie, before or during the 2023-2024 RSV season.

Treatment:

Other: Nirsevimab

Cohort 2: Comparator Cohort

Description:

Full-term (born ≥ 37 weeks gestational age) infants born on or after 01 April 2023, without a high-risk condition, who do not receive nirsevimab before or during the 2023-2024 RSV season.

Cohort 3: Historical Control Cohort

Description:

Full-term (born ≥ 37 weeks gestational age) infants without a high-risk condition from previous RSV seasons 2016-2017, 2017-2018, 2018-2019, 2019-2020, and 2022-2023. The 2020-2021 and 2021-2022 seasons are excluded due to low circulation of RSV during the COVID-19 pandemic. Historical seasons' data are intended for descriptive purpose only, to contextualize the impact of the treatment during the 2023-2024 season.

Cohort 4: Infant Cohort with High-Risk Conditions

Description:

Infants born \< 37 weeks gestational age and those diagnosed with a high-risk condition between birth and the end of the observation period (regardless of gestational age at birth), will be considered infants with high-risk conditions. Infants with high-risk conditions will be excluded from Cohort 1, Cohort 2, and Cohort 3. Descriptive statistics will be separately assessed for this high-risk cohort.