NCT06325332

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49,680 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 0 Days – 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
OTHER	Nirsevimab	Route of Administration: Intramuscular Pharmaceutical Form: Solution for injection

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-03-22
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study