The study was partially funded by the Italian Medicines Agency (AIFA).
FMI, RDC conceived and designed the study, coordinated and supervised data collection at all sites, analyzed the data, critically reviewed and approved the final manuscript as submitted. LDD conceived and designed the study, coordinated and supervised data collection at two sites, drafted, critically reviewed and approved the final manuscript as submitted. CZ, MSS, NM, AC, UR collected data, validated cases, drafted and reviewed the manuscript. SR, LR, PDP, PB, SS collected and validated data, reviewed and approved the final manuscript as submitted. All components of the Italian Multicenter Study Group for Drug and Vaccine Safety in Children collected and validated the data within the clinical centers, read, commented and approved the final version of the manuscript. All authors read and approved the final manuscript.
The authors declare that they have no competing interests.
Ethical approval and consent to participate
According to the Italian regulation, retrospective observational studies are only required to be notified to ethical committees (Determinazione AIFA 20 marzo 2008 - http://www.agenziafarmaco.gov.it/allegati/det_20marzo2008.pdf). The study protocol was notified to the ethical committee of each participating Center. Before parents interview, a written informed consent to use data for research purposes was obtained.
Members of the Italian Multicenter Study Group for Drug and Vaccine Safety in Children
Francesca Menniti-Ippolito, Roberto Da Cas, Giuseppe Traversa (National Center for Epidemiology, National Institute of Health, Roma); Carmela Santuccio, Patrizia Felicetti, Loriana Tartaglia, Francesco Trotta (Italian Medicines Agency, Roma); Pasquale Di Pietro, Paola Barabino, Salvatore Renna, Laura Riceputi (Giannina Gaslini Pediatric Hospital, Genova); Pier-Angelo Tovo, Clara Gabiano, Antonio Urbino, Luca Baroero, Daniele Le Serre, Silvia Virano (Department of public health and pediatrics, Torino University, Regina Margherita Pediatric Hospital, Torino); Liviana Da Dalt, Chiara Stefani, Claudia Zerbinati (Department of Pediatrics, Treviso Hospital, Treviso); Giorgio Perilongo, Marco Daverio, Michela Maretti, Beatrice Galeazzo, Giulia Rubin, Stefania Scanferla (Department of Pediatrics, University of Padova); Elena Chiappini, Sara Sollai, Maurizio De Martino, Sabrina Becciani, Martina Giacalone, Simona Montano, Giulia Remaschi, Alessia Stival (Anna Meyer Children’s University Hospital, Firenze); Piera Abate, Ilaria Leonardi (Department of Pediatrics, University of Perugia); Nicola Pirozzi, Umberto Raucci, Antonino Reale, Rossella Rossi (Pediatric Emergency Department, Bambino Gesù Children Hospital, Roma); Nadia Mores, Giulia Bersani, Adele Compagnone, Antonio Chiaretti, Riccardo Riccardi, Costantino Romagnoli (Pharmacology and Pediatrics, Università Cattolica S. Cuore, Roma); Vincenzo Tipo, Michele Dinardo, Fabiana Auricchio, Teodoro Polimeno, Maria Colomba Bonagura (Santobono Pediatric Hospital, Napoli); Alessandra Maccariello (Department of Experimental Medicine, Section of Pharmacology “L. Donatelli”, Second University of Napoli); Fortunata Fucà, Eleonora Di Rosa (Giovanni Di Cristina Pediatric Hospital, Palermo); Domenica Altavilla, Anna Mecchio, Teresa Arrigo (Department of Pediatrics, Gynecologic, Microbiologic and Biomedical Sciences, University Hospital, Messina).