作者
Michael G Ison, Alberto Papi, Joanne M Langley, Dong-Gun Lee, Isabel Leroux-Roels, Federico Martinon-Torres, Tino F Schwarz, Richard N Van Zyl-Smit, Nancy Dezutter, Nathalie De Schrevel, Laurence Fissette, Marie-Pierre David, Marie Van Der Wielen, Lusine Kostanyan, Veronica Hulstrøm
发表日期
2022/12/1
期刊
Open Forum Infectious Diseases
卷号
9
期号
Supplement_2
页码范围
ofac492. 1868
出版商
Oxford University Press
简介
Background
RSV-associated acute respiratory infections (ARI), particularly lower respiratory tract diseases (LRTD), present a significant disease burden in older adults. Currently, there are no approved vaccines against RSV. We present results from an ongoing study designed to demonstrate the vaccine efficacy (VE) of the AS01E-adjuvanted RSVPreF3 OA in adults ≥ 60 YOA.
Methods
This ongoing, phase 3, observer-blind, placebo-controlled, multi-country study (NCT04886596) enrolled adults ≥ 60 YOA from the northern and southern hemispheres. Participants were randomized (1:1) to receive a single dose of RSVPreF3 OA or placebo before the RSV season. The primary objective was to demonstrate VE of a single dose of RSVPreF3 OA in preventing RSV-confirmed LRTD during one RSV season (criterion: lower limit of VE confidence interval [CI] > 20%). VE is reported …
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