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

Respiratory Syncytial Virus Clinical Trial

— BEAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325332
• Other study ID #: RSV00080
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: April 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33000
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus

Intervention

Other:
• Nirsevimab
Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California: Site number 0001	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of first episodes of polymerase chain reaction (PCR)-confirmed RSV with an lower respiratory tract disease (LRTD)	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)	Approximately 6 months
Primary	Number of medical encounters associated with the first episode of PCR-confirmed RSV with a LRTD diagnosis	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.	Approximately 6 months
Secondary	Number of respiratory-related medical encounters	Number of respiratory-related medical encounters (ie, Outpatient visits, Emergency department visits, In patient hospitalizations, and Intensive care unit hospitalizations) by ICD-10 codes.	Approximately 6 months
Secondary	Number of respiratory-related medical encounters for LRTD by ICD-10 codes	Number of respiratory-related medical encounters for LRTD by ICD-10 codes.	Approximately 6 months
Secondary	Incidence of PCR-confirmed RSV (first occurrence of season)	Incidence of PCR-confirmed RSV (first occurrence of season).	Approximately 6 months
Secondary	Number of medical encounters for otitis media by ICD-10 codes	Number of medical encounters for otitis media by ICD-10 codes.	Approximately 6 months
Secondary	Number of antibiotic prescriptions by National Drug Code (NDC) codes	Number of antibiotic prescriptions by NDC codes.	Approximately 6 months