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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Respiratory Syncytial Virus
Interventions: Nirsevimab
Countries: United States
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.
Sex: ALL
Age: 0 Days to 12 Months
Healthy volunteers: Yes
Study type: OBSERVATIONAL
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.
- Oakland, California, United States