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

Last updated: January 13, 2025
Sponsor: Sanofi Pasteur, a Sanofi Company
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Nirsevimab

Clinical Study ID

NCT06325332
RSV00080
  • Ages < 12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The Kaiser Permanente Northern California, USA (KPNC) member born on or after 01April 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

Exclusion Criteria:

  • Mother was administered an RSV vaccine during her pregnancy with the infantparticipant.

  • 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.

Study Design

Total Participants: 49680
Treatment Group(s): 1
Primary Treatment: Nirsevimab
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Kaiser Permanente Northern California: Site number 0001

    Oakland, California 94612
    United States

    Site Not Available

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