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)
NCT05437510 is registered in ClinicalTrials.gov with Sanofi Pasteur, a Sanofi Company as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus no Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE)
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Phase
- Phase 3
- Overall status
- Completed
- Start date
- August 8, 2022
- Completion date
- April 9, 2025
- Enrollment
- 8,057 (actual)
- Sites
- 240
Conditions
As the registry lists them; a condition with its own page is linked.
healthy volunteer, rsv immunization