Bivalent RSVpreF Vaccine in Adults 18 to <60 Years Old With High-Risk Conditions.

ABSTRACT:

Background

Older individuals and adults with certain chronic or immunocompromising health conditions are at increased risk of severe respiratory syncytial virus (RSV) disease.

Methods

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 immunogen

SUBMITTER: Davis M 

PROVIDER: S-EPMC12043053 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature