This study is currently not recruiting participants.

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

Investigating the Effectiveness of Investigational Medication Against Respiratory Syncytial Virus in Infants

Not Recruiting
12 months or below
All
Phase N/A
49680 participants needed

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.

This study investigates the effectiveness of an investigational medication against RSV (Respiratory Syncytial Virus) in infants. RSV can lead to lower respiratory tract disease and other related medical encounters.

The study evaluates how the investigational medication impacts medical encounters related to respiratory diagnoses, otitis media, and antibiotic prescriptions. It focuses on assessing the overall effectiveness and impact of the medication against PCR-confirmed RSV.

  • Who can participate: Infants who are members of Kaiser Permanente Northern California, born on or after April 1, 2023, and entering their first RSV season can participate. Eligibility to receive the investigational medication is defined by the product indication.
  • Study details: Participants will receive the investigational medication to evaluate its effectiveness against RSV. A placebo may be used in the study.
Updated on 23 May 2026. Study ID: NCT06325332