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Authors
Martinon-Torres, Federico
Virta, Miia M.
Koski, Susanna
de la Cueva, Ignacio Salamanca
Szymanski, Henryk T.
Bosis, Samantha
Drăgănescu, Anca C.
Silfverdal, Sven-Arne
Zambrano, Betzana
Dhingra, Mandeep S.
B’Chir, Siham
Syrkina, Olga
Lyabis, Olga
Vasquez, Gustavo A.
Rehm, Christine
,
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Clinical Trials BETA
Clinical trials referenced in this document:
nct03547271 at ClinicalTrials.govDocuments that mention this clinical trial
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial
https://doi.org/10.1007/s40121-025-01190-7
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Funding
Funding for this research was provided by:
Sanofi
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Article History
Received: 13 May 2025
Accepted: 23 June 2025
First Online: 15 July 2025
Declarations
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: Betzana Zambrano, Mandeep Singh Dhingra, Siham B’Chir, Olga Syrkina, Olga Lyabis, Christine Rehm, and Gustavo Vasquez are employees of Sanofi and may hold shares and/or stock options in the company. Federico Martinon-Torres has acted as principal investigator in this trial and also in other randomized controlled trials of Ablynx, Abbot, Seqirus, Sanofi Pasteur MSD, Sanofi Pasteur, Cubist, Wyeth, Merck, Pfizer, Roche, Regeneron, Jansen, Medimmune, Moderna, Novavax, Novartis, and GSK, with honoraria paid to his institution. He also reports consulting or advisory relationship with AstraZeneca, GSK Vaccines SRL, BioNet, Biofabri, Pfizer Inc, Sanofi Pasteur Inc, Seqirus Janssen Pharmaceuticals Inc, and MSD. Susanna Koski acted as a principal investigator for the study reported in this manuscript, which was sponsored by Sanofi. She is an employee of Finnish Vaccine Research (FVR), which conducts clinical vaccine studies for many major vaccine manufacturers, including Sanofi. Henryk T Szymanski reports personal fees and trial fees paid to his institution from MSD, Seqirus, Pfizer, Janssen, and Sanofi Pasteur. Miia Virta, Ignacio Salamanca de la Cueva and Samantha Bosis have no conflicts of interest to declare. Anca Cristina Drăgănescu acted as a principal investigator for the study reported in this manuscript, which was sponsored by Sanofi. Sven-Arne Silfverdal acted as a principal investigator for the study reported in this manuscript, which was funded by Sanofi, and also for other trials sponsored by GSK, Jansen, Medimmune, MSD, and Pfizer. He has been a member of advisory boards for Astra, GSK, MSD, Pfizer, and Sanofi Pasteur, with honoraria to his institution or personal.
: The study was conducted in compliance with the International Conference on Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. Informed consent was obtained from participants’ parents (or legal guardian) before any study procedures were performed. The protocol and any amendments were approved by applicable independent ethics committees or institutional review boards at each participating site and the appropriate regulatory agencies in each country (Supplementary methods).
