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Article History

Received: 5 February 2025

Revised: 14 April 2025

Accepted: 21 April 2025

First Online: 2 May 2025

Declarations

:

: The NIRSE-GAL study protocol was approved by the regional independent reference ethics committee of Galicia (CEIC 2023–377). The study was developed in compliance with the International Council for Harmonization Guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. Data were obtained through the electronic registries of the Galician surveillance system by personnel independent of data analysis and were anonymised before analysis.

: Patients were immunized as part of the public health system immunization schedule, offered to all eligible infants, and no informed consent is required either for immunization purposes or for study purposes, as reassured by the ethics committee.

: The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The funders provided support during the planning of the statistical analysis and reviewed the statistical section of the “.”

: Federico Martinón-Torres has 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, Novavax, Novartis and GSK, with honoraria paid to his institution. Irene Rivero-Calle has acted as subinvestigator in randomized controlled trials of Ablynx, Abbot, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, Medimmune, Novavax, Novartis and GSK, with honoraria paid to her institution. Federico Martinon-Torres and Irene Rivero-Calle report a relationship with GSK Vaccines SRL that includes: consulting or advisory. Federico Martinon-Torres and Irene Rivero-Calle report a relationship with Pfizer Inc that includes: consulting or advisory. Federico Martinón-Torres and Irene Rivero-Calle report a relationship with Sanofi Pasteur Inc that includes: consulting or advisory. Federico Martinón-Torres reports a relationship with Janssen Pharmaceuticals Inc that includes: consulting or advisory. Federico Martinón-Torres and Irene Rivero-Calle report a relationship with MSD that includes: consulting or advisory. Federico Martinón-Torres reports a relationship with Seqirus Pty Ltd that includes: consulting or advisory. Rolf Kramer, Jing Jin and Leticia Platero-Alonso are Sanofi employees and may hold shares and/or stock options in the company. The remaining authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.