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

Study on Investigational Treatment for RSV Prevention in Infants

Recruiting
12 months or below
All
Phase N/A
33000 participants needed
1 Location

Study 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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus
  • Age: 12 months or below
  • Gender: All

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.

Updated on 04 Jun 2024. Study ID: NCT06325332

This study investigates the effectiveness of an investigational medication against RSV, a virus that causes lung infections. The purpose is to see how well this medicine works in preventing RSV-related illnesses and medical visits in infants. RSV stands for Respiratory Syncytial Virus, which can lead to serious lung problems, especially in young children.

During the study, infants will receive the investigational medication to see if it reduces the number of doctor visits and hospital stays due to RSV. The study will also look at how the medicine affects other conditions like ear infections and the need for antibiotics.

  • Who can participate: Infants born on or after April 1, 2023, who are entering their first RSV season and are members of Kaiser Permanente Northern California are eligible. Infants whose mothers received an RSV vaccine during pregnancy or who had other RSV prevention treatments are not eligible.
  • Study details: Participants will receive nirsevimab to test its effectiveness against RSV. The study will monitor the infants for any medical visits related to RSV and other infections.

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