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

Investigating the Effectiveness of an Investigational Medication for RSV

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.

Updated on 04 Apr 2025. Study ID: NCT06325332

This study investigates the effectiveness of an investigational medication against confirmed cases of Respiratory Syncytial Virus (RSV) in the lower respiratory tract. RSV is a virus that can cause infections in the lungs and respiratory tract. The study also looks at related medical encounters, which means doctor's visits or hospital stays related to RSV.

Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. Researchers will compare the outcomes to see how well the investigational medication works against RSV and other related health issues.

  • Who can participate: Infants born on or after April 1, 2023, who are Kaiser Permanente Northern California members and eligible to receive the investigational medication can participate. Infants entering their first RSV season are considered.
  • Study details: Participants will receive either the investigational medication or a placebo. Researchers will monitor the infants for RSV infections and other health issues to evaluate the medication's effectiveness.