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Article History

Received: 20 June 2025

Accepted: 4 January 2026

First Online: 29 January 2026

Declarations

:

: The trial was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice guidelines. The trial was approved by The Regional Danish Committee on Biomedical Research Ethics (H-21035316) and the Danish Medicines Agency (EudraCT no. 2021-003170-31). The trial is registered on August 31, 2021 at Clinicaltrials.gov: NCT05048589.

: Written informed consent was obtained from all participants.

: SS, MML, JN and RCH are full-time employees of Sanofi and may own shares and/or stock options in the company. CSL is chief physician at Danske Lægers Vaccinations Service, part of European LifeCare Group, and has received speaker fees and served on advisory boards for GSK, MSD, Pfizer, Takeda, and Valneva. BLC has received consulting fees from Amgen, Cardurion, Corvia, Myokardia, and Novartis. SDS has received research grants from Actelion, Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, BMS, Celladon, Cytokinetics, Eidos, Gilead, GSK, Ionis, Lilly, Mesoblast, MyoKardia, NIH/NHLBI, Neurotronik, Novartis, Novo Nordisk, Respicardia, Sanofi, Theracos, US2.AI and consulted for Abbott, Action, Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi-Sankyo, GSK, Lilly, Merck, Myokardia, Novartis, Roche, Theracos, Quantum Genomics, Cardurion, Janssen, Cardiac Dimensions, Tenaya, Sanofi, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, and Puretech Health. LK has received speaker fees from Novo Nordisk, Novartis, AstraZeneca and Boehringer Ingelheim. TBS has received research grants from Bayer, Novartis, Pfizer, Sanofi Pasteur, GSK, Novo Nordisk, AstraZeneca, Boston Scientific and GE Healthcare, consulting fees from Novo Nordisk, IQVIA, Parexel, Amgen, CSL Seqirus, GSK and Sanofi Pasteur, and lecture fees from AstraZeneca, Bayer, Novartis, Sanofi Pasteur, GE healthcare and GSK.