Trautmannsberger, Ilona https://orcid.org/0000-0002-9996-6117
Plagg, Barbara https://orcid.org/0000-0002-6116-7504
Adamek, Ina https://orcid.org/0009-0004-9614-1058
Mader, Silke https://orcid.org/0000-0002-3396-0177
de Luca, Daniele https://orcid.org/0000-0002-1639-9138
Esposito, Susanna
Silfverdal, Sven Arne
Zimmermann, Luc J. I. https://orcid.org/0000-0002-1409-3821
Tischer, Christina https://orcid.org/0000-0001-6699-9484
,
Article History
Received: 3 April 2024
Accepted: 2 May 2024
First Online: 20 May 2024
Declarations
:
: Sven Arne Silfverdal contributed to vaccine trials and advisory board meetings for various pharmaceutical companies outside the submitted work. Additionally, Daniele de Luca serves as a lecturer for AstraZeneca unrelated to the present study. Barbara Plagg, Daniele de Luca, Susanna Esposito, Sven Arne Silfverdal and the PEG and ESAB members received a compensation fee from EFCNI for consulting services associated with the current study. Ilona Trautmannsberger, Ina Adamek, Silke Mader, Luc J.I. Zimmermann and Christina Tischer declare that they have no competing interests.
: Prior to initiating recruitment of the study, the Ethics Committee of the University of Maastricht in the Netherlands officially waived the requirement for ethics approval (reference number METC 2022-3307). Following the confirmation of ethical exemption, the study was registered on clinicaltrials.gov (ID NCT05550545). Data collection, processing, and storage adhered to the General Data Protection Regulation and the Declaration of Helsinki. The study itself followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies. Informed consent was secured from all participants through a confirmation box checked before starting the questionnaire. Participants were informed about the potential for distressing reactions regarding their personal situations or experiences and were given the opportunity to cease participation at any point during the survey. No financial incentives were provided to study participants. Ethical review and approval were waived as the Medical Research Involving Human Subjects Act (WMO) did not apply to the study. Informed consent was obtained from all participants involved in the study. Written informed consent was obtained from the patient(s) to publish this paper.