Safety and Immunogenicity of NVX-CoV2705

This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M® (NVX-CoV2705) in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from coronavirus disease 2019 (COVID 19) previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. The goal will be to enroll a similar number of participants in the 2 age cohorts (≥ 65 years and 12 through 64 years) and in the 12 through 64 years age cohort, an effort will be made to enroll a similar number of participants in the 2 age subcohorts (12 through 17 years and 18 through 64 years). Approximately 120 participants, approximately 60 participants in each age cohort and approximately 30 participants in each age subcohort, will be enrolled to receive a single dose of NVX-CoV2705 on Day 0 and remain on study for immunogenicity until Day 28 and safety data collection through 180 days post-vaccination.