Trial Profile

A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 16 May 2025

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At a glance

Drugs Nirsevimab (Primary)
Indications Respiratory syncytial virus infections
Focus Registrational; Therapeutic Use
Acronyms HARMONIE
Sponsors Sanofi Pasteur

Most Recent Events

11 Apr 2025 Status changed from active, no longer recruiting to completed.
25 Feb 2025 Planned End Date changed from 14 Mar 2025 to 27 Feb 2025.
28 Dec 2023 Primary endpoint has been met, (Overall incidence of RSV LRTI hospitalization through the RSV season: Number of RSV LRTI hospitalization through the RSV season), as per Results published in the New England Journal of Medicine

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