@article{a8e6d5b8e061483db7c8cf5570a34250,
title = "Safety and reactogenicity of a liquid formulation of human rotavirus vaccine (porcine circovirus-free): A phase III, observer-blind, randomized, multi-country study",
author = "Lau, {Yu Lung} and {Fan Leung}, Ting and {Sirvan Cetin}, Benhur and {Cagri Dinleyici}, Ener and Huang, {Li Min} and Halperin, {Scott A.} and Hsiao, {Chien Chou} and Bruce Tapiero and Mary Tipton and Campbell, {James D.} and Leentje Moerman and Michael Povey and Dan Bi and Tina Singh",
note = "Funding Information: The authors thank all participants involved in the study, study nurses, coordinators and study investigators. The authors are grateful to Meda Kondolot (Erciyes University Faculty of Medicine, Turkey) for her contribution to the study. The authors are grateful to the members of the Independent Data Monitoring Committee: Carlo Giaquinto, Shabir Madhi, Nigel Cunliffe, Catherine Legrand and Dennis Conrad for providing a valuable contribution in the review of the safety data. The authors would also like to thank Tina Van den Meersche and Manuel Zocco (Modis c/o GSK) for medical writing support and manuscript coordination. Rota-096 group members. The authors would like to thank the Rota-096 study group including: Naresh Aggarwal (Aggarwal and Associates Ltd, Brampton, Canada), Francois Boucher (CHU de Qu{\'e}bec - Universit{\'e} Laval, Qu{\'e}bec, Canada), Sau-Man Chan (The University of Hong Kong, Hong Kong), Kate Ching-Ching Chan (Department of Paediatrics, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong), Nan-Chang Chiu (Mackay Memorial Hospital, Taipei, Taiwan), Gilbert T Chua (The University of Hong Kong, Hong Kong), Meltem Dinleyici (Eskisehir Osmangazi University, Eskisehir, Turkey), Joseph Domachowske (University Heath Care Center UHCC, Syracuse, Unites States), Ronke Dosunmu (Foundation Pediatrics, East Orange, United States), Peter Dzongowski (Milestone Research, London, Canada), Murdo Ferguson (Colchester Research Group, Truro, Canada), Nicole George (Pediatric Associates of Fairfield, Fairfield, United States), Hsin-Chun Huang (Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan), Tolga Ince (Dokuz Eylul University Medical Faculty, Izmir, Turkey), James Kellner (Alberta Children's Hospital, Calgary, Canada), Daniel Leung (The University of Hong Kong, Hong Kong), Noelle Anne Ngai (Department of Paediatrics, Prince of Wales Hospital, Hong Kong), Sahra Niazi (Midwest Children's Health Research Institute, Lincoln, United States), Christopher Peltier (Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, United States), Christine Rivers (The Corvallis Clinic, Corvallis, United States), Walter Rok (Pediatric Associates of Fall River, Fall River, United States), Stephen Russell (Midwest Childrens Health Research Institute, Lincoln, United States), Gary Schlichter (Murray Pediatrics, Murray, United States), Jaime Sou Da Rosa Duque (The University of Hong Kong, Hong Kong), Wing Hung Tam (Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong), Paul Wisman (Pediatric Research of Charlottesville LLC, Charlottesville, United States), Karen Kwan-Ming Yam (Department of Paediatrics, Prince of Wales Hospital, Hong Kong), Ho Chung Yau (Department of Paediatrics, Prince of Wales Hospital, Hong Kong), Maggie Lo-Yee Yau (Department of Paediatrics, Prince of Wales Hospital, Hong Kong). Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. Funding Information: DB, LM, MP and TS are employees of the GSK group of companies, and DB, LM and TS hold shares in the GSK group of companies as part of their employee remuneration. BT, ECD, JDC, SAH and YLL received grants from the GSK group of companies during the conduct of the study. BT{\textquoteright}s institution received research grants for vaccine-related studies from Merck, GSK and Pfizer. SAH declares other financial relationships with Sanofi, Pfizer, Merck, Entos, IMV Inc. and VBI Vaccines outside of the submitted work. SAH declares having served on a data safety monitoring board for Medicago, advisory boards for Pfizer, Merck, GSK, Sanofi, AstraZeneca, Moderna, Medicago, and has received payment for expert testimony from the Province of Ontario, Canada. Additionally, SAH serves as a co-chair of the Vaccine Surveillance Reference Group, Public Health Agency of Canada. ECD declares other financial relationships with Sanofi Pasteur, Pfizer and the GSK group of companies outside of the submitted work. BSC, CCH, LMH, MT and TFL have no competing interest to declare. The authors have no non-financial competing interest to declare. Publisher Copyright: {\textcopyright} 2022 GlaxoSmithKline Biologicals S.A.",
year = "2022",
month = mar,
day = "25",
doi = "10.1016/j.vaccine.2022.02.065",
language = "English",
volume = "40",
pages = "2184--2190",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "14",
}
