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NCT06325332 · ClinicalTrials.gov registry record
BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
A clinical trial, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- 49,680
- Enrollment target
NCT06325332: Completed study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06325332 is a clinical trial that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 49,680 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06325332 has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- 49,680 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- OTHER Nirsevimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49,680 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-06-30 |
What the finished NCT06325332 record still lists
NCT06325332 is an observational study that tracks outcomes without assigning an intervention. Its 49,680 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Nirsevimab is the first listed.
NCT06325332 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06325332 about?
NCT06325332 is a clinical study titled "BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)". 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 med...
What is the current status of trial NCT06325332?
This trial is currently completed. The enrollment target is 49,680 participants. The study started on 2024-04-01. Estimated completion is 2025-06-30.
What interventions are being tested in trial NCT06325332?
The interventions under investigation include: Nirsevimab (OTHER).
Who is sponsoring clinical trial NCT06325332?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
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