Investor Presentaiton
HARMONIE
STUDY
HARMONIE study confirms pivotal
trial data in real world setting
Days 1
181
1st visit:
randomization
Monthly
follow up
Primary
completion
Participants:
8,000+ infants
≥29 weeks
gestational age¹
Beyfortus
N = 4,037
No intervention
N=4,021
366
1 year
follow-up
SB Drysdale, (2023, May 8-12). A Phase 3 randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial
virus (RSV) in infants (HARMONIE) [Oral presentation]. ESPID 2023: Lisbon, Portugal. 1. Not eligible for palivizumab
24 Vaccines Investor Event
sanofi
Primary endpoint
> Reduction of hospitalization
due to RSV Lower-
Respiratory-Tract-Infection
(LRTI)
Study objectives
> Showcase seamless
implementation in real
world setting
> Enrich hospitalization data
in France, Germany and UK
> Confirm safety profile
in large populationView entire presentation