BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants
Investigating the Effectiveness of the Investigational Vaccine Nirsevimab Against RSV in Infants
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:
- To estimate the effectiveness of nirsevimab against medical encounters with a respiratory related diagnosis.
- To estimate the effectiveness of nirsevimab against medical encounters with an LRTD diagnosis.
- To estimate the impact of nirsevimab on PCR-confirmed RSV.
- To estimate the impact of nirsevimab on medical encounters with an otitis media diagnosis.
- 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 vaccine against respiratory syncytial virus (RSV) in infants. The study aims to understand how well the investigational vaccine works in preventing RSV-related medical visits and infections confirmed by a specific test called polymerase chain reaction (PCR).
Participants in the study will be observed for medically-attended RSV events, which means the researchers will track any medical visits related to RSV or respiratory issues. The study will also examine the impact of the investigational vaccine on other medical diagnoses such as ear infections and the need for antibiotics.
- 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 are eligible. Participants must be eligible to receive the investigational vaccine according to its product indication. Infants whose mothers received an RSV vaccine during pregnancy or who received other RSV prophylaxis are excluded.
- Study details: Participants will be observed for medical visits related to RSV and respiratory issues. Researchers will collect data on the effectiveness of the investigational vaccine nirsevimab in preventing these medical encounters.
