BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
NCT ID: NCT06325332
Last Updated: 2025-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
49680 participants
OBSERVATIONAL
2024-04-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Nirsevimab-Exposed Cohort
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.
Nirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Cohort 2: Comparator Cohort
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.
No interventions assigned to this group
Cohort 3: Historical Control Cohort
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.
No interventions assigned to this group
Cohort 4: Infant Cohort with High-Risk Conditions
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.
No interventions assigned to this group
Interventions
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Nirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible to receive nirsevimab as defined by the product indication.
* KPNC infants entering their first RSV season.
Exclusion Criteria
* 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.
0 Days
12 Months
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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Kaiser Permanente Northern California: Site number 0001
Oakland, California, United States
Countries
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Other Identifiers
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RSV00080
Identifier Type: -
Identifier Source: org_study_id
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