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Completed

NCT Number: NCT06325332

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

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.

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Key information

Conditions

Respiratory Syncytial Virus

Age range

0 day–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California: Site number 0001

Oakland, California, 94612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nirsevimab

Other

Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Other names: Beyfortus™

Primary outcomes

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

    Time frame: Approximately 6 months

    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)

  2. Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis

    Time frame: Approximately 6 months

    Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis identified using ICD-10 codes: outpatient (OP) visits, emergency department (ED) visits, inpatient (IP) hospitalizations or intensive care unit (ICU) hospitalizations.

Secondary outcomes

  1. Number of respiratory-related medical encounters

    Time frame: Approximately 6 months

    Number of respiratory-related medical encounters (ie, Outpatient visits, Emergency department visits, In patient hospitalizations, and Intensive care unit hospitalizations) by ICD-10 codes.

  2. Number of respiratory-related medical encounters for LRTD by ICD-10 codes

    Time frame: Approximately 6 months

    Number of respiratory-related medical encounters for LRTD by ICD-10 codes.

  3. Incidence of PCR-confirmed RSV (first occurrence of season)

    Time frame: Approximately 6 months

    Incidence of PCR-confirmed RSV (first occurrence of season).

  4. Number of medical encounters for otitis media by ICD-10 codes

    Time frame: Approximately 6 months

    Number of medical encounters for otitis media by ICD-10 codes.

  5. Number of antibiotic prescriptions by National Drug Code (NDC) codes

    Time frame: Approximately 6 months

    Number of antibiotic prescriptions by NDC codes.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Acronym: BEAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 22, 2024
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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