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Article History

Received: 10 December 2024

Accepted: 25 February 2025

First Online: 1 April 2025

Declarations

:

: Céline Zocchetti, Olga Syrkina, Siham Bchir and Isabelle Bertrand-Gerentes are employees of Sanofi and may hold shares and/or stock options in the company. Mika Rämet: Finnish Vaccine Research Ltd. (formerly Tampere University Vaccine Research Center) carries out clinical vaccine trials sponsored by all major vaccine manufacturers including Sanofi. Rolf Ebert has no conflicts of interest to disclose. Robert Simko: Scientific lecture fees from Sanofi. Federico Martinón-Torres: Acted as principal investigator in randomized controlled trials of Ablynx, Abbot, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, Medimmune, Moderna, Novavax, Novartis, and GSK, with honoraria paid to his institution. FM-T also reports consulting or advisory relationships with GSK Vaccines SRL, Pfizer Inc, Sanofi Pasteur Inc, Janssen Pharmaceuticals Inc, Moderna, MSD, and Seqirus Pty Ltd.

: This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines, including the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and all applicable laws, rules, and regulations. The study protocol, informed consent form, and investigator’s brochure were reviewed and approved by the Independent Ethics Committee (IEC) and/or Investigational Review Board (IRB) for each study site before the study was initiated. The IECs/IRBs for all study centers are listed in the supplementary materials (Supplementary Table 1). Parents or other legally acceptable representatives of participants were required to sign a statement of informed consent.