biostudies-literatureUnknown80(4)Davis MPfizer<h4>Background</h4>Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe respiratory syncytial virus (RSV) disease.<h4>Methods</h4>In this phase 3 randomized trial of RSVpreF safety and immunogenicity in 18-59-year-olds at high risk of severe RSV disease, participants were randomized 2:1 to 1 RSVpreF (120 µg) or placebo dose. Primary safety endpoints included reactogenicity events and adverse events (AEs) through 7 days and 1 month after vaccination, respectively, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) throughout the study. In primary analyses, immunogenicity elicited 1 month after RSVpreF was bridged to a randomly selected subset of ≥60-year-olds receiving RSVpreF from the immunogenClinical infectious diseases : an official publication of the Infectious Diseases Society of America911-920https://www.ebi.ac.uk/biostudies/studies/S-EPMC12043053biostudies-literatureBivalent RSVpreF Vaccine in Adults 18 to &lt;60 Years Old With High-Risk Conditions.PMC12043053Doust MChaudhry AMajid-Mahomed ZClark JStacey HAlmeida NCHowitt WBoghara HJiang QKalinina EMauri MDeHaan EDavis MOnoya MWyper HHulinsky ITowner WSuplicy FMONeT Study TeamDavis JTaylor DMehta SCarter MAnderson ASDever MGurtman AKlein TRosen JRahman FLino MMMishkin DCannon KMalkin EDenham DNeutel JHowland WLi WSarwar UNMunjal ICooper DSmith WJuarez ECohen JBailey MDiemert DPatton MSwanson KADeAtkine DfalseBivalent RSVpreF Vaccine in Adults 18 to &lt;60 Years Old With High-Risk Conditions.<h4>Background</h4>Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe respiratory syncytial virus (RSV) disease.<h4>Methods</h4>In this phase 3 randomized trial of RSVpreF safety and immunogenicity in 18-59-year-olds at high risk of severe RSV disease, participants were randomized 2:1 to 1 RSVpreF (120 µg) or placebo dose. Primary safety endpoints included reactogenicity events and adverse events (AEs) through 7 days and 1 month after vaccination, respectively, and serious AEs (SAEs) and newly diagnosed chronic medical conditions (NDCMCs) throughout the study. In primary analyses, immunogenicity elicited 1 month after RSVpreF was bridged to a randomly selected subset of ≥60-year-olds receiving RSVpreF from the immunogen2025-01-01T00:00:00Z2025 Apr2026-06-03T02:40:56.439Z2025-07-06T03:05:56.908ZS-EPMC120430533952354710.1093/cid/ciae550