Sully, Kate
Bonner, Nicola
Bradley, Helena
von Maltzahn, Robyn
Arbuckle, Rob
Walker-Nthenda, Louise
Mahon, Aoife
Becker, Brandon
O’Hara, Louise
Bevans, Katherine B.
Kosinski, Mark
Zeiger, Robert S.
Mackenzie, Ross
Nelsen, Linda
Funding for this research was provided by:
GlaxoSmithKline (208194)
Article History
Received: 3 March 2021
Accepted: 17 October 2021
First Online: 6 November 2021
Declarations
:
: The project was conducted according to the principles outlined in the Declaration of Helsinki and in line with guidelines related to Good Clinical Practice published by the US Food and Drug Administration and European Medicines Agency, where they are applicable to non-interventional research such as this. In addition, all data were handled in accordance with Health Insurance Portability and Accountability Act guidelines and the European General Data Protection Regulation for the security and privacy of health data. Ethical approval in the US was provided by Copernicus Group IRB, a centralized IRB. Additional ethical approval was not a requirement in Poland, but parents/caregivers were required to provide written informed consent for their child’s inclusion in the study. In Argentina, documents approved by Copernicus Group IRB were provided to the site to achieve local site approval. For Spain, the study was communicated with the Surveillance Unit of FarmaIndustria, who reviewed and approved the study. Each child and their parent/caregiver were given full oral and written information about the nature, purpose, possible risk and benefits of the study, were given the opportunity to ask questions, and were allowed time to consider the information provided within the informed consent form. They were also notified of their right to discontinue their participation in the study at any time. The signed and dated informed consent form for each participant was obtained before any medical information was accessed, before contact details were provided to the recruitment agency/Adelphi Values, and before they were asked to perform any study-related activities. Copies of the informed consent form were signed by both the physician and the parent/caregiver, and the child and their parent/caregiver were provided with a copy. In the case of children aged 10–11 years, the child’s parent/caregiver also signed the consent form, with additional space for the child to sign and indicate their ‘assent’ to participate. For children below the age of 10 years, the parent/caregiver alone signed the consent form.
: Not applicable.
: RvM, LW-N and LN are employees of GlaxoSmithKline plc. and hold shares in the company. KS, NB, HB, RA, AM and LO were all employees of Adelphi Values at the time of this study; Adelphi Values received funding from GSK for the conduct of this study. RSZ reports grants from NHLBI, Genentech, MedImmune/AstraZeneca, TEVA Pharmaceuticals, ALK, Quest Diagnostics, and Merck & Co, Inc outside the submitted work; personal fees from GlaxoSmithKline plc. for the submitted work; and personal fees outside the submitted work from AstraZeneca, Genentech/Novartis, Merck & Co, Inc and Regeneron Pharmaceuticals. BB, KBB, MK and RM have no competing interests to declare.