Díez-Domingo, Javier
Simkó, Róbert
Icardi, Giancarlo
Chong, Chan Poh
Zocchetti, Céline
Syrkina, Olga
Bchir, Siham
Bertrand-Gerentes, Isabelle
Clinical trials referenced in this document:
Documents that mention this clinical trial
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study
https://doi.org/10.1007/s40121-024-01009-x
Funding for this research was provided by:
Sanofi
Article History
Received: 15 March 2024
Accepted: 13 June 2024
First Online: 2 July 2024
Declarations
:
: Céline Zocchetti, Olga Syrkina, Siham Bchir and Isabelle Bertrand-Gerentes are employees of Sanofi and may hold shares and/or stock options in the company. Javier Díez-Domingo received sponsorship from Sanofi for the conduct of clinical trial; received grants from GSK, MSD, and Sanofi paid to institution; received consulting fees from GSK, MSD, and Sanofi; received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from GSK, MSD, and Moderna; received support for attending meetings from Sanofi and MSD. Róbert Simkó, Chan Poh Chong and Giancarlo Icardi received sponsorship from Sanofi for the conduct of clinical trial and received payment or honoraria for scientific lectures from Sanofi.
: This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki and the International Council for Harmonization (ICH) guidelines for Good Clinical Practice (GCP), and all applicable laws, rules, and regulations. Participants turning 18 years old during the study or parents/legal representatives provided informed consent. Ethical approval was obtained from the following committees: Singapore: NHG Domain Specific Review Boards (DSRB). Spain: Comité de Ética de la Investigación Con Medicamentos del Hospital General Universitario Gregorio Marañón. Hungary: Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottság/ Medical Research Council Ethics Committee for Clinical Pharmacology. Italy: Comitato Etico Regionale Liguria Largo Rosanna Benzi; Comitato Etico Milano Area 1 – ASST Sacco e Fatebenefratelli; Comitato Etico dell’Area Vasta Emilia Nord; Segreteria Locale di Parma c/o Azienda Ospedaliero; Universitaria di Parma Via Gramsci 14; Comitato Etico Palermo 1; Comitato Etico “Ospedali Riuniti” Di Foggia; Comitato Etico Regione Calabria—Sezione Area Centro.