Vir Singh, Puneet http://orcid.org/0000-0002-1363-7815
Tiberi, Paola http://orcid.org/0000-0001-7970-4980
Di Domenico, Gabriele Filippo http://orcid.org/0000-0001-9848-7360
Romolini, Valerio
Mzolo, Thembile http://orcid.org/0000-0002-9453-6302
Costantini, Marco http://orcid.org/0000-0003-4709-2590
Akhund, Tauseefullah
Basile, Venere http://orcid.org/0000-0002-7475-7749
Lattanzi, Maria http://orcid.org/0000-0002-3457-426X
Pellegrini, Michele http://orcid.org/0000-0001-8505-9260
Clinical trials referenced in this document:
Documents that mention this clinical trial
Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis
https://doi.org/10.1007/s40264-022-01242-8
Documents that mention this clinical trial
Fully Liquid MenACWY-CRM Vaccine: Results from an Integrated Safety Analysis
https://doi.org/10.1007/s40264-022-01242-8
Funding for this research was provided by:
GlaxoSmithKline Biologicals SA
Article History
Accepted: 19 September 2022
First Online: 11 November 2022
Declarations
:
: GlaxoSmithKline Biologicals SA funded this study/research and was involved in all stages of study conduct, including analysis of the data. GlaxoSmithKline Biologicals SA also took in charge all costs associated with the development and publication of this article.
: PVS, PT, GFDD, VR, TM, MC, VB, ML, and MP are employed by GSK. TA was employed by GSK when the analyses were conducted. PVS, TA, VB, ML, and MP hold shares in GSK. PVS, PT, GFDD, VR, TM, MC, TA, VB, ML, and MP declare no other financial and non-financial relationships and activities.
: Anonymized individual participant data and study documents can be requested for further research from ExternalRef removed.
: Not applicable.
: Studies #1 and #2 (NCT03652610 and NCT03433482) were conducted in accordance with the Declaration of Helsinki and Good Clinical Practice and approved by the appropriate ethics committees.
: Before enrolment in the studies, all individual participants aged at least 18 years provided written informed consent and parents/legally acceptable representatives provided written informed consent for individual participants younger than 18 years.
: Not applicable.
: All authors contributed to the concept and design of the post hoc analysis. PVS, PT, GFDD, VR, TM, MC, and VB contributed to data generation and collection. All authors contributed to the analysis of data. All authors contributed to the writing or review of the manuscript and approved the final version for submission.
: <i>Menveo</i> is a trademark owned by or licensed to GSK.