Herrera-Restrepo, Oscar https://orcid.org/0000-0001-8193-999X
Afroz, Nuzhat https://orcid.org/0000-0002-3048-2704
Cabrera, Eliazar Sabater https://orcid.org/0000-0002-3184-2855
Reaney, Matthew https://orcid.org/0000-0003-2918-722X
Sowell, France Ginchereau https://orcid.org/0000-0002-7728-2435
Kumar, Ramiya https://orcid.org/0000-0002-0651-8316
Stillman, Alicia https://orcid.org/0009-0000-0295-7752
Wukovits, Patti https://orcid.org/0009-0005-6091-6314
Rodrigues, Mariana https://orcid.org/0009-0009-4867-8615
Pinto, Sofia B. https://orcid.org/0000-0001-7758-6706
Kocaata, Zeki https://orcid.org/0000-0002-5231-3389
Onwude, Obinna https://orcid.org/0009-0008-1811-7684
Funding for this research was provided by:
GSK (ETMF-219353)
Article History
Received: 11 June 2024
Accepted: 25 September 2024
First Online: 29 October 2024
Declarations
:
: Oscar Herrera-Restrepo, Eliazar Sabater Cabrera, and Zeki Kocaata are employees and stockholders of GSK; Sofia B. Pinto is an employee of GSK. Matthew Reaney, France Ginchereau Sowell, Ramiya Kumar, and Obinna Onwude are employees of IQVIA, which was paid by GSK to conduct this study. Nuzhat Afroz is a current employee of Novo Nordisk, and was an employee of IQVIA during the time the study was conducted. Alicia Stillman, Patti Wukovits, and Mariana Rodrigues are affiliated with the American Society for Meningitis Prevention (formerly the Meningitis B Action Project), which receives educational grants from GSK and Pfizer via the Kimberly Coffey Foundation and the Emily Stillman Foundation. Alicia Stillman, Patti Wukovits, and Mariana Rodrigues received no payment for recruitment and were blinded to any identifiable information from recruited participants.
: This study was conducted in accordance with the study protocol, the Guidelines for Good Pharmacoepidemiology Practices published by the International Society of Pharmacoepidemiology, the ethical principles of the Declaration of Helsinki, and IRB requirements. IRB approval was sought and obtained from the USA-based WCG IRB. Participants and the study sponsor were blinded from each other (i.e., participants were not aware of the study sponsor and only directly interacted with the investigators, and the study sponsor was not aware of any participant identifying information at any point during study conduct). All participants ≥ 18 years old provided informed consent prior to their participation in the research study; participants < 18 years old provided assent, in addition to consent from their caregiver/legal guardian.