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Article History

Accepted: 12 September 2021

First Online: 25 October 2021

Declarations

:

: GlaxoSmithKline Biologicals SA funded this study (GSK study identifier: 207749) and was involved in all stages of the study, including analysis of the data. GlaxoSmithKline Biologicals SA also took charge of all costs associated with the development and publication of this present manuscript.

: Elisa Cinconze, Ugo Nwoji, Emily Lu, Huajun Wang, and Emad Yanni are employees of the GSK group of companies. Ugo Nwoji, Emily Lu, Huajun Wang, and Emad Yanni hold shares in the GSK group of companies. Xavier Martínez Gómez declares he has received financial support from Pax-Vax for participation on advisory boards for vaccines, from Pfizer for participation at conferences, and from the GSK group of companies for practical courses. Ignacio Salamanca de la Cueva declares he has received grants and/or honoraria as a consultant/advisor for attending conferences and practical courses from the GSK group of companies, Sanofi Pasteur, MSD, and Pfizer. Elisa Cinconze, Ugo Nwoji, Emily Lu, Huajun Wang, Emad Yanni, Xavier Martínez-Gómez, and Ignacio Salamanca de la Cueva declare no other financial or non-financial relationships and activities. Tamara Eckermann and Lode Godderis declare no financial and non-financial relationships and activities and no conflicts of interest.

: Anonymised individual participant data and study documents can be requested for further research from ExternalRef removed.

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The following ethics committees (ECs), institutional review boards, and regulatory authorities were consulted in line with country requirements, namely Commissie Medische Ethiek UZ/KU Leuven (EC) in Belgium (approval received 13 September 2019), Ethik-Kommission der Bayerischen Landesärztekammer (EC) in Germany (approval received 13 September 2019), and, in Spain, CCEIBA and CCAA for Andalusia (approval received 25 July 2019) and Vall d´Hebron, Medicinal Product Research Ethics Committee of Hospital Universitari Vall d´Hebron (approval received 17 July 2019) and Generalitat de Catalunya, Directorate General of Management and Health Regulation (CCAA) (approval received 25 September 2019) for Catalonia.

: Written informed consent or assent was obtained from all individual participants included in this study or their parent(s), guardian(s), or legally acceptable representative(s) prior to participation in the study.

: All authors participated in the design, implementation, analysis, and interpretation of the study and the development of this manuscript. All authors had full access to the data and gave final approval prior to submission.

: <i>AlphaRix Tetra</i>, <i>Influsplit Tetra,</i> and <i>Fluarix Tetra</i> are trademarks owned by or licensed to the GSK group of companies.