Doua, Joachim
Rodríguez-Baño, Jesús
Froget, Rachel
Puranam, Padma
Go, Oscar
Geurtsen, Jeroen
van Rooij, Sanne
Vilken, Tuba
Minoru, Inage
Yasumori, Izumi
Spiessens, Bart
Tacconelli, Evelina
Biehl, Lena M.
Thaden, Joshua T.
Sarnecki, Michal
Goossens, Herman
Poolman, Jan
Bonten, Marc
Ekkelenkamp, Miquel
,
Violette, Madison
Munshi, Sonal
Aitabi, Moussa
Lammens, Christine
Van Mieghem, Sofie
Van Puyvelde, Sandra
Xavier, Basil Britto
Azzini, Anna Maria
Righi, Elda
Salerno, Nicola Duccio
Lo, Giuliana
Cremonini, Cascio Eleonora
Pascual, Álvaro
Espíndola, Reinaldo
Palomo, Virginia
Walker, Sarah
Ruffin, Felicia
Dagher, Michael
Varjačić, Andreja
Funding for this research was provided by:
Janssen Research & Development
Innovative Medicines Initiative Joint Undertaking (115523, 115523, 115523, 115523, 115523, 115523, 115523, 115523, 115523, 115523)
University Medical Center Utrecht
Article History
Received: 16 August 2023
Accepted: 18 December 2023
First Online: 25 January 2024
Declarations
:
: JD: Employee and stock option owner of Janssen Research & Development, a pharmaceutical company of Johnson & Johnson. OG: Employee of Janssen Research & Development, a pharmaceutical company of Johnson & Johnson and a shareholder of Johnson & Johnson. JG: Employee and stock (option) owner of Janssen Vaccines & Prevention, a pharmaceutical company of Johnson & Johnson. BS: Employee and share owner of Johnson & Johnson. MS: Employee and unrestricted share owner of Janssen Vaccines, Branch of Cilag GmbH International, a Johnson & Johnson company. JP: Employee and stock option owner of Janssen Research & Development, a pharmaceutical company of Johnson & Johnson. MB: Grants paid to University Medical Center Utrecht (UMCU) from CureVac, Janssen Vaccines, Merck, and Novartis; honoraria payments to MJMB from Takeda; participation on a Data Safety Monitoring Board supported by AstraZeneca, Merck, Novartis, Pfizer, Sanofi, and Spherecydes. JRB, RF, PP, SvR, TV, IM, IY, ET, LMB, JTT, HG, ME: The authors declare that they have no competing interests. Author(s) JD, OG, JG, BS, MS, and JP belong to EFPIA (European Federation of Pharmaceutical Industries and Association) member companies in the Innovative Medicines Initiative Joint Undertaking (IMI JU), and costs related to their part in the research were carried by the respective company as in kind contribution under the IMI JU scheme.
: This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. In countries where no waiver was obtained, participants or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature/purpose of the study, and the participation and termination conditions. The protocol, Informed Consent Form, and other relevant documents were submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC) by the investigator and reviewed and were approved by the IRB/IEC before the study was initiated.
: Not available.