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Article History

Received: 10 June 2025

Revised: 19 August 2025

Accepted: 2 September 2025

First Online: 25 October 2025

Declarations

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: The study was conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from all study sites prior to the initiation of the research; Ethikkommission der Universität zu Lübeck (no. 20–345) and Ethik-Kommission der Universität Würzburg (no. 1/20_z) in Germany, Comité de Ética de la Investigación de Santiago y Lugo (no. 2020/452) and Comité de Ética de la Investigación Hospital Universitario La Paz (no. 22/2020) in Spain; Comitato Etico Regione Toscana—Pediatricoc/o Azienda Ospedaliero Universitaria Meyer (no. 247/2020) and Comitato Etico Ospedale Pediatrico Bambino Gesù IRCCS (no. 2275/2020) in Italy; London—Brighton & Sussex Research Ethics Committee (no. 21/LO/0578) in England; Comité de protection des personnes Sud Ouest et Outre Mer IV Cabanis Haut – Centre Cabanis Haut (no. 20.10.09.60811/CPP2020-11-094b) in France. Written informed consent was obtained from the parents/legally authorized representatives.

: Yoonyoung Choi and Madelyn Ruggieri are employees at Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. FM-T has acted as principal investigator in randomized controlled trials of Ablynx, Abbot, Seqirus, Sanofi Pasteur, MSD, Pfizer, Roche, Regeneron, Jansen, Medimmune, Novavax, Novartis and GSK, with honoraria paid to his institution. FM-T reports a relationship with GSK Vaccines SRL that includes consulting or advisory. FM-T reports a relationship with Pfizer Inc that includes consulting or advisory. FM-T reports a relationship with Sanofi Pasteur Inc that includes consulting or advisory. FM-T reports a relationship with Janssen Pharmaceuticals Inc that includes consulting or advisory. FM-T reports a relationship with MSD that includes consulting or advisory. FM-T reports a relationship with Seqirus Pty Ltd that includes consulting or advisory. SBD has previously received honoraria from Sanofi for taking part in RSV advisory boards and has provided consultancy and/or investigator roles in relation to product development for Janssen, AstraZeneca, Pfizer, Moderna, Valneva, MSD, iLiAD and Sanofi with fees paid to my institution. SBD is a member of the UK Department of Health and Social Care’s (DHSC) Joint Committee on Vaccination and Immunisation (JCVI) RSV subcommittee and Medicines and Healthcare products Regulatory Agency’s (MHRA) Paediatric Medicine Expert Advisory Group (PMEAG), but the reviews expressed herein do not necessarily represent those of DHSC, JCVI, MHRA or PMEAG. JGW has been an investigator for clinical trials sponsored by pharmaceutical companies including AstraZeneca, MSD, Pfizer, Sanofi, and Janssen and an investigator for clinical trials funded by IMI/Horizon2020 and ZonMw. All funds have been paid to UMCU. JGW participated in advisory boards of Janssen and Sanofi and was a speaker at a Sanofi sponsored symposium with honoraria paid to UMCU. LB has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. UMCU has received major funding (> €100,000 per industrial partner) for investigator initiated studies from AstraZeneca, Sanofi, Janssen, Pfizer, MSD and MeMed Diagnostics. UMCU has received major funding from the Bill and Melinda Gates Foundation. UMCU has received major funding as part of the public private partnership IMI-funded RESCEU and PROMISE projects with partners GSK, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi. UMCU has received major funding by Julius Clinical for participating in clinical studies sponsored by AstraZeneca, Merck and Pfizer. UMCU received minor funding (€1000–25,000 per industrial partner) for consultation, DSMB membership or invited lectures by Ablynx, Bavaria Nordic, GSK, Novavax, Pfizer, Moderna, Astrazeneca, MSD, Sanofi, Janssen. LB is the founding chairman of the ReSViNET Foundation. EH has received speaking fees and travel support from Pfizer, MSD, Sanofi, Abbvie/AstraZeneca and Chiesi. RE has previously received honoraria for lectures, expertise or educational events. RE has previously received honoraria from AstraZeneca and Sanofi for taking part in RSV advisory boards and also from AstraZeneca, GSK Pfizer, and Sanofi for lectures, expertise or educational events. RE has acted as principal investigator in randomized controlled trials of AstraZeneca, Sanofi, GSK, with honoraria paid to his institution. JB has previously received honoraria from MSD and ALK for taking part in advisory boards and from AstraZeneca, MSD, and Sanofi for lectures, expertise or educational events. JL has been an investigator for clinical trials sponsored by pharmaceutical companies including AstraZeneca, GSK, MSD, Pfizer and Sanofi and received consulting or lecture fees from Enanta, Engelhard Pharma, Gilead Sciences, MSD, Pfizer, Sanofi and Siemens Health Care. CA has received fees for meetings or consulting or advisory boards from Astra Zeneca, GSK, MSD, Moderna, Novavax, Pfizer, Sanofi.