Respiratory Syncytial Virus
Conditions
Keywords
RSV
Brief summary
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.
Interventions
OTHERNirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 12 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) | Approximately 6 months | Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD) diagnosis identified using International Classification of Diseases, Tenth Revision (ICD) |
| Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis | Approximately 6 months | Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis identified using ICD-10 codes: outpatient (OP) visits, emergency department (ED) visits, inpatient (IP) hospitalizations or intensive care unit (ICU) hospitalizations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of PCR-confirmed RSV (first occurrence of season) | Approximately 6 months | Incidence of PCR-confirmed RSV (first occurrence of season). |
| Number of respiratory-related medical encounters | Approximately 6 months | Number of respiratory-related medical encounters (ie, Outpatient visits, Emergency department visits, In patient hospitalizations, and Intensive care unit hospitalizations) by ICD-10 codes. |
| Number of antibiotic prescriptions by National Drug Code (NDC) codes | Approximately 6 months | Number of antibiotic prescriptions by NDC codes. |
| Number of medical encounters for otitis media by ICD-10 codes | Approximately 6 months | Number of medical encounters for otitis media by ICD-10 codes. |
| Number of respiratory-related medical encounters for LRTD by ICD-10 codes | Approximately 6 months | Number of respiratory-related medical encounters for LRTD by ICD-10 codes. |
Countries
United States
Outcome results
None listed