{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T05:17:14Z","timestamp":1788585434958,"version":"build-2803163510"},"reference-count":33,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Vaccines"],"abstract":"<jats:p>Background\/Objectives: The bivalent RSVpreF vaccine is effective at preventing respiratory syncytial virus (RSV)-associated lower respiratory tract illness in adults. However, data regarding safety and immunogenicity of RSVpreF in Korean populations are limited. Methods: This was a phase 3, multicenter, placebo-controlled, randomized (2:1), double-blind study in Korean adults 60 years of age and older. Participants received a single 120-\u03bcg dose of RSVpreF or matching placebo. Safety endpoints included local reactions and systemic events through 7 days and adverse events (AEs) through 1 month after vaccination, and serious AEs (SAEs) throughout the study. RSV-A and RSV-B serum 50% neutralizing geometric mean titers (GMTs) and geometric mean fold rises (GMFRs) were obtained 1 month after vaccination. Results: Overall, 377 participants received study intervention (RSVpreF, n = 251; placebo, n = 126). Most local reactions and all systemic events were of mild or moderate severity. Injection-site pain was the most frequently reported local reaction (RSVpreF, 12.4%; placebo, 3.2%). The most frequently reported systemic events were fatigue (RSVpreF, 23.1%; placebo, 26.2%) and muscle pain (RSVpreF, 15.5%; placebo, 9.5%). AEs through 1 month after vaccination were infrequent (RSVpreF, 3.6%; placebo, 0.8%); none were considered vaccine related by the investigator. RSV-A and RSV-B neutralizing GMTs increased 1 month after RSVpreF, with GMFRs (95% CIs) from before to 1 month after vaccination of 9.5 (8.51\u201310.67) for RSV-A and 8.3 (7.37\u20139.39) for RSV-B. Conclusions: In older Korean adults, RSVpreF had an acceptable safety and tolerability profile and elicited robust RSV neutralizing responses 1 month after vaccination consistent with pivotal phase 3 efficacy trial results. ClincalTrials.gov Identifier: NCT06593587 (date of registration: 9 September 2024).<\/jats:p>","DOI":"10.3390\/vaccines14090773","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T10:10:33Z","timestamp":1788430233000},"page":"773","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Randomized Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Bivalent RSVpreF Vaccine in Older Adults in Korea"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5874-4764","authenticated-orcid":false,"given":"Won Suk","family":"Choi","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Korea University College of Medicine, Seoul 02708, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Karen","family":"Quan","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Australia, Sydney, NSW 2000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6798-4399","authenticated-orcid":false,"given":"James A.","family":"Baber","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Australia, Sydney, NSW 2000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5181-845X","authenticated-orcid":false,"given":"Anna","family":"Jaques","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Australia, Sydney, NSW 2000, Australia"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Karla Janse","family":"van Rensburg","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer UK, Marlow SL7 1HZ, Buckinghamshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"methodology","vocabulary":"credit"},{"role":"data-curation","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Wen","family":"Li","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Collegeville, PA 19426, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Mark W.","family":"Cutler","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Elena V.","family":"Kalinina","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Annaliesa S.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3389-8414","authenticated-orcid":false,"given":"Kena A.","family":"Swanson","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Alejandra","family":"Gurtman","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"methodology","vocabulary":"credit"},{"role":"formal-analysis","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Iona","family":"Munjal","sequence":"additional","affiliation":[{"name":"Pfizer Vaccines, Pfizer Inc., Pearl River, NY 10965, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,9,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/j.ccm.2016.11.010","article-title":"Respiratory syncytial virus infection: An illness for all ages","volume":"38","author":"Walsh","year":"2017","journal-title":"Clin. 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