Koski, Susanna https://orcid.org/0000-0003-2078-8475
Martinon-Torres, Federico https://orcid.org/0000-0002-9023-581X
Rämet, Mika https://orcid.org/0000-0002-5776-164X
Zolotas, Lefteris
Newton, Ryan
Maansson, Roger
Cutler, Mark https://orcid.org/0000-0002-5302-5477
Peyrani, Paula https://orcid.org/0000-0001-8958-1734
Findlow, Jamie https://orcid.org/0000-0001-5153-4043
Balmer, Paul https://orcid.org/0000-0001-8188-1791
Jodar, Luis https://orcid.org/0000-0003-1246-530X
Gruber, William C. https://orcid.org/0000-0002-6518-4547
Anderson, Annaliesa S. https://orcid.org/0000-0002-6413-1718
Beeslaar, Johannes https://orcid.org/0000-0003-0454-3515
Funding for this research was provided by:
Pfizer
Article History
Received: 5 September 2024
Accepted: 10 December 2024
First Online: 30 January 2025
Declarations
:
: Susanna Koski and Federico Martinon-Torres acted as principal investigators for the study reported in this manuscript, which was sponsored by Pfizer. Susanna Koski and Mika Rämet are employees of Finnish Vaccine Research (FVR), which conducts clinical vaccine studies for many major vaccine manufacturers, including Pfizer. Federico Martinon-Torres has acted as principal investigator for other studies sponsored by Abbot, Cubist, GlaxoSmithKline, Janssen, Medimmune, MSD, Novavax, Novartis, Pfizer, Regeneron, Roche, Sanofi Pasteur, and Seqirus, with honoraria paid to his institution; and has consulting or advisory relationships with GlaxoSmithKline, Janssen, MSD, Pfizer, Sanofi Pasteur, and Seqirus. All other authors are current or former employees of Pfizer and may hold stock or stock options in the company.
: The study was conducted in accordance with consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences Ethical Guidelines, applicable International Conference on Harmonisation Good Clinical Practice guidelines, and applicable laws and regulations. The protocol and related documents were reviewed and approved by the Ethics Committee Hospital District of Southwest Finland (study sites in Finland; reference number 7/1800/2021), Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Krakowie (Poland; reference number 11/KBL/OIL/2021), and Comité de Ética de Investigación con Medicamentos del Hospital Universitario 12 de Octubre (Spain; reference number 21/040) before study initiation. A parent or legal guardian of each study participant provided written informed consent before the participant was enrolled.