![]() ![]() Written informed consent was obtained from all participants before any study procedures were performed. The protocol and amendments were approved by Independent Ethics Committees (country ethics committees for Honduras, France, Spain and the UK, a central ethics committee for the USA and local ethics committees for the USA and for Australia ) as per local regulations. The study was undertaken in compliance with the International Conference on Harmonization guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. The details of the IRB/oversight body that provided approval or exemption for the research described are given below: I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002. Department of Health and Human Services under Contract # HHSO100201600005I, and in collaboration with the U.S. ![]() Sanofi and federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness and Response at the U.S. He receives research funding from other vaccine manufacturers relating to trials and studies and undertakes paid consultancy related to a number of developmental antimicrobial drugs and vaccines. AF receives research funding, paid to his employers, from Sanofi both for work related to this study and other unrelated vaccine trials and from GSK for other unrelated studies. FM-T has also acted as principal investigator in randomized controlled trials of the above-mentioned companies as well as Ablynx, Gilead, Regeneron, Roche, Abbott, Novavax, and MedImmune, with honoraria paid to his institution. FM-T has received honoraria from GSK group of companies, Pfizer Inc, Sanofi, MSD, Seqirus, Biofabri, and Janssen for taking part in advisory boards and expert meetings and for acting as a speaker in congresses outside the scope of the submitted work. DMRM declares that her institution received funding from Sanofi. FTDS was employed by GSK, and held restricted shares in the GSK group of companies, at the time of the study. MAC, LS and MK are employed by GSK and hold restricted shares in the GSK group of companies. SSr, RMC, GdB, CAD and SSa, are inventors on a pending patent application filed by Sanofi and GSK for the development of the CoV-2 dTM vaccine. SSa was a Sanofi employee at the time of study conduct. GdB, JW, AP, MSR, HA, MIB, RC, RF, BF, JG, M-HG, SG, OH, RM, JP, NR, RMC and SSa are Sanofi employees MIB, RMC hold stock options. Funding Sanofi and federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness and Response at the U.S.
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