作者
Niklas Dyrby Johansen, Daniel Modin, Joshua Nealon, Sandrine Samson, Camille Salamand, Matthew M Loiacono, Carsten Schade Larsen, Anne Marie Reimer Jensen, Nino Emanuel Landler, Brian L Claggett, Scott D Solomon, Martin J Landray, Gunnar H Gislason, Lars Køber, Jens Ulrik Stæhr Jensen, Pradeesh Sivapalan, Lasse Skafte Vestergaard, Palle Valentiner-Branth, Tyra Grove Krause, Tor Biering-Sørensen
发表日期
2023/1/24
期刊
NEJM evidence
卷号
2
期号
2
页码范围
EVIDoa2200206
出版商
Massachusetts Medical Society
简介
Background
The relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccines (QIV-HD) versus standard-dose quadrivalent influenza vaccines (QIV-SD) against hospitalizations and mortality in the general older population has not been evaluated in an individually randomized trial. Because of the large sample size required, such a trial will need to incorporate innovative, pragmatic elements.
Methods
We conducted a pragmatic, open-label, active-controlled, randomized feasibility trial in Danish citizens aged 65 to 79 years during the 2021–2022 influenza season. Participants were randomly assigned 1:1 to receive QIV-HD or QIV-SD. Randomization was integrated into routine vaccination practice, and the trial relied solely on nationwide administrative health registries for data collection. Outcomes consisted of a feasibility assessment and descriptive rVE estimates.
Results
We invited 34,000 …
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ND Johansen, D Modin, J Nealon, S Samson… - NEJM evidence, 2023