Immunogenicità e Sicurezza della Vaccino contro il Virus Sinciziale Respiratorio (RSV) con Proteina F Prefusione adiuvantata con AS01E nei soggetti adulti di 18-49 anni a rischio aumentato di malattia da RSV rispetto agli adulti di ≥60 anni.

BACKGROUND: The AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) is approved for ≥60-year-olds and 50-59-year-olds at increased risk of RSV disease. We evaluated the vaccine's immunogenicity and safety in 18-49-year-olds at increased risk of RSV disease due to certain chronic conditions. METHODS: This open-label, multicountry phase 3b trial included 18-49-year-olds at increased risk (at-risk 18-49 group) and a control group of ≥60-year-olds with or without chronic conditions (≥60 group). Primary objective was to demonstrate immunological noninferiority to adjuvanted RSVPreF3 in the at-risk 18-49 versus ≥60 group, based on group RSV-A