Dos Santos, Gael http://orcid.org/0000-0001-8623-3478
Nguyen, Bach-Yen
Damaso, Silvia http://orcid.org/0000-0003-4851-4396
Godderis, Lode
Martínez-Gómez, Xavier
Eckermann, Tamara
Loos, Hugo
Salamanca de la Cueva, Ignacio
Shende, Vishvesh http://orcid.org/0000-0002-2245-7330
Schmidt, Alexander C. http://orcid.org/0000-0003-4757-3335
Yeakey, Anne http://orcid.org/0000-0003-3691-3445
Article History
First Online: 28 December 2019
Compliance with Ethical Standards
:
: Gael Dos Santos, Silvia Damaso, Anne Yeakey and Bach-Yen Nguyen declare they are employed by the GSK group of companies and hold shares in the GSK group of companies. Xavier Martínez Gómez declares having received financial support from PaxVax for participation on advisory boards for vaccines and from Pfizer for participation at conferences. Alexander C. Schmidt declares he was employed by the GSK group of companies at the time of the study conduct and holds shares in the GSK group of companies. Vishvesh Shende declares he is employed by VPN Consultancy Limited, working on behalf of the GSK group of companies. Hugo Loos, Lode Godderis, Tamara Eckermann and Ignacio Salamanca de la Cueva declare they have no conflicts of interest.
: GlaxoSmithKline Biologicals SA is the funding source and was involved in all stages of the study, and funded all costs associated with the development and publishing of the present manuscript. All authors had full access to the data and agreed with the submission of the publication.
: 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), or Institutional Review Boards (IRBs) and Regional Authorities were consulted in line with country requirements, namely Commissie Medische Ethiek UZ/KU Leuven (EC) in Belgium (S61698; approval received 24 August); Ethik-Kommission der Bayerischen (EC) in Germany (18056; approval received 20 September); and, in Spain, the PEIBA (IRB and RA combined) for Andalusia (0031/18 EPA-SP; approval received 26 September) and Hospital Vall de Hebron (IRB) and Goli Gurina (RA) for Catalonia (ID-RTF-021; approval received 22 October).
: Informed consent was obtained from all individual participants included in this study.
: To request access to patient-level data and documents for this study, please submit an enquiry via ExternalRef removed.
: AlphaRix Tetra, Influsplit Tetra and Fluarix Tetra are trademarks of the GSK group of companies.