Product
Nirsevimab
Aliases
MEDI8897
Name
BEYFORTUS
INN Name
nirsevimab
FDA Approved
Yes
6 clinical trials
1 organization
5 indications
1 document
Indication
Lower Respiratory Tract InfectionIndication
Respiratory Syncytial Virus ImmunizationIndication
Healthy VolunteerIndication
Respiratory Syncytial Virus InfectionIndication
Respiratory Syncytial Virus InfectionsClinical trial
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Nirsevimab, a Monoclonal Antibody With Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm and Term Infants in ChinaStatus: Recruiting, Estimated PCD: 2025-05-02
Clinical trial
A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)Status: Active (not recruiting), Estimated PCD: 2024-03-27
Clinical trial
A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children ≤ 24 Months of AgeStatus: Completed, Estimated PCD: 2023-02-17
Clinical trial
A Phase III Single-Arm Open-Label Study to Evaluate the Safety PK ADA and Anti RSV nAb Following Administration of 2 Doses of Nirsevimab Given 5 to 6 Months Apart in Infants With CHD, CLD, Immunocompromise, Down Syndrome, or Born Pre-Term in JapanStatus: Active (not recruiting), Estimated PCD: 2024-09-18
Clinical trial
Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine ImmunizationStatus: Recruiting, Estimated PCD: 2026-03-31
Clinical trial
Real-World Effectiveness of Perinatal RSV ImmunoprophylaxisStatus: Not yet recruiting, Estimated PCD: 2028-12-30
Document
DailyMed Label: BEYFORTUSOrganization
Sanofi Pasteur Inc.