作者
Michael G Ison, Alberto Papi, Eugene Athan, Robert G Feldman, Joanne M Langley, Dong-Gun Lee, Isabel Leroux-Roels, Federico Martinon-Torres, Tino F Schwarz, Richard N van Zyl-Smit, Céline Verheust, Nancy Dezutter, Olivier Gruselle, Laurence Fissette, Marie-Pierre David, Lusine Kostanyan, Veronica Hulstrøm, Aurélie Olivier, Marie Van der Wielen, Dominique Descamps
发表日期
2024/6/15
期刊
Clinical Infectious Diseases
卷号
78
期号
6
页码范围
1732-1744
出版商
Oxford University Press
简介
Background
The adjuvanted RSV prefusion F protein–based vaccine (RSVPreF3 OA) was efficacious against RSV-related lower respiratory tract disease (RSV-LRTD) in ≥60-years-olds over 1 RSV season. We evaluated efficacy and safety of 1 RSVPreF3 OA dose and of 2 RSVPreF3 OA doses given 1 year apart against RSV-LRTD over 2 RSV seasons post–dose 1.
Methods
In this phase 3, blinded trial, ≥60-year-olds were randomized (1:1) to receive RSVPreF3 OA or placebo pre–season 1. RSVPreF3 OA recipients were re-randomized (1:1) to receive a second RSVPreF3 OA dose (RSV_revaccination group) or placebo (RSV_1dose group) pre–season 2; participants who received placebo pre–season 1 received placebo pre–season 2 (placebo group). Efficacy of both vaccine regimens against RSV-LRTD was evaluated over 2 seasons combined (confirmatory secondary …
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MG Ison, A Papi, E Athan, RG Feldman, JM Langley… - Clinical Infectious Diseases, 2024