From the *AFPA, Association Française de Pédiatrie Ambulatoire, Orléans, France
†ACTIV, Association Clinique Thérapeutique Infantile du Val de Marne
‡Université Paris Est, IMRB-GRC GEMINI, Créteil, France
§Clinical Research Center (CRC), Centre Hospitalier Intercommunal de Créteil, Créteil, France
¶CompuGroup Medical France, Nanterre, France
‖Unité d’épidémiologie clinique, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré, ECEVE INSERM UMR 1123, Paris, France.
Accepted for publication January 15, 2021
Supported by Association Clinique Thérapeutique Infantile du val de Marne (ACTIV) and Association Française de Pédiatrie Ambulatoire (AFPA).
R.C. received personal fees and nonfinancial support from Pfizer; reported personal fees from Merck, GSK, Sanofi and AstraZeneca outside the submitted work. N.G. received nonfinancial support from Pfizer outside the submitted work. B.F. is employed by CompuGroup Medical France. F.V.L.S. reported personal fees from MSD Vaccins and GSK outside the submitted work. G.T. reported personal fees and nonfinancial support from MSD Vaccins, Sanofi Aventis, Pfizer outside the submitted work. F.C.-S. reported personnal fee and nonfinancial support from MSD Vaccins and Sanofi outside the submitted work. A.W. reported personal fees from MSD Vaccins, Sanofi Aventis, ALK-Abello, GSK, Pierre Fabre, Shire, Novartis and Pfizer outside the submitted work. N.O. received nonfinancial support from Pfizer, GSK and Sanofi outside the submitted work. C.L. received personal fees and nonfinancial support from Pfizer and Merck outside the submitted work. The other authors have no conflicts of interest to disclose.
R.C., S.B., N.O. and C.L. analyzed and interpreted the data and drafted the article. S.B. and C.L. performed the statistical analysis. All authors revised and approved the article and designed the study.
The study was approved by the French National Commission on Informatics and Liberty (no. 1921226) and by an ethics committee (CHI Créteil Hospital, France). The study was registered at ClinicalTrials.gov (NCT04471493).
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com).
Address for correspondence: Corinne Levy, MD, ACTIV, 31, rue Le Corbusier, 94000 Créteil, France. E-mail: [email protected].