Nirsevimab delivers 83 percent reduction in RSV infant hospitalizations in a real world clinical trial setting: Sanofi
RSV is the most common cause of LRTD, including bronchiolitis and pneumonia, in infants.;
,Paris: Sanofi has announced that the new data from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention.
The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large, multi-country European interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. The trial recruited more than 8,000 infants and took place at nearly 250 sites across France, Germany and the United Kingdom. The data from HARMONIE were presented at the 41st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID).
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