Project summary
A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)
The Harmonie study is a clinical trial investigating the effectiveness of Nirsevimab. This monoclonal antibody can be used to prevent Respiratory Syncytial Virus (RSV) infections infants. The aim of this study is to determine how effective a single intramuscular dose of Nirsevimab is at protecting infacts from serious illness due to RSV, in some cases this can lead to hospital admission in this age group. The study involved over 8,000 infants across multiple countries, providing real-world data on the efficacy and safety of this treatment during 2022-2023 RSV season. The results indicated that the Nirsevimab significantly reduced RSV related hospital admissions by 83%. The SCAS research team are proud to have been involved in this study and offer home visits to those family who were unable to easily attend clinics.
Patient Group
Healthy infants 12 months or under
Participating areas in SCAS
Across Hampshire, Berkshire, Oxfordshire and Buckinghamshire.
How are patients selected for this project?
Parents register their interest in the study using the online platform, before completing a telephone edibility screening consultation with one of our team. Parents would be offered a home visit and the SCAS research team would complete the screening process before the randomisation visit, this was a unique opportunity provided only for those within the South Central geography.
Closing date
This study closed summer 2025
Further information
Harmonie RSV Study – Vaccine Institute – St George’s, University of London