Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial.

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Title: Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial.
Authors: Ison MG; Bethesda, MD, USA., Papi A; Pulmonary Division, University of Ferrara, St Anna University Hospital, Ferrara, Italy., Athan E; Barwon Health, University Hospital Geelong, Geelong, VIC, Australia; Centre for Innovation in Infectious Diseases and Immunology Research, Deakin University, Geelong, VIC, Australia., Feldman RG; Senior Clinical Trials, Laguna Hills, CA, USA., Langley JM; Canadian Center for Vaccinology, Dalhousie University, IWK Health and Nova Scotia Health, Halifax, NS, Canada., Lee DG; Division of Infectious Diseases, Department of Internal Medicine, Vaccine Bio Research Institute, College of Medicine, The Catholic University of Korea, Seoul, South Korea., Leroux-Roels I; Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium., Martinon-Torres F; Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain; Genetics, Vaccines, Infectious Diseases, and Pediatrics Research Group, Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Spain; Consorcio Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain., Schwarz TF; Institute of Laboratory Medicine and Vaccination Center, Klinikum Würzburg Mitte, Campus Juliusspital, Würzburg, Germany., van Zyl-Smit RN; Division of Pulmonology and University of Cape Town Lung Institute, Department of Medicine, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa., Cuadripani S; GSK, Stevenage, UK., Deraedt Q; GSK, Wavre, Belgium., Dezutter N; GSK, Wavre, Belgium., Gerard C; GSK, Rixensart, Belgium., Fissette L; GSK, Wavre, Belgium., Xavier S; GSK, Bengaluru, India., David MP; GSK, Wavre, Belgium., Olivier A; GSK, Wavre, Belgium., Van der Wielen M; GSK, Wavre, Belgium. Electronic address: marie.x.van-der-wielen@gsk.com., Descamps D; GSK, Wavre, Belgium.
Corporate Authors: AReSVi-006 study group
Source: The Lancet. Respiratory medicine [Lancet Respir Med] 2025 Jun; Vol. 13 (6), pp. 517-529. Date of Electronic Publication: 2025 Apr 14.
Publication Type: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III; Multicenter Study
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 101605555 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2213-2619 (Electronic) Linking ISSN: 22132600 NLM ISO Abbreviation: Lancet Respir Med Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:2213-2619
DOI:10.1016/S2213-2600(25)00048-7