Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants
New England Journal of Medicine2020Vol. 383(5), pp. 426–439
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Shabir A. Madhi, Fernando P. Polack, Pedro A. Piedra, Flor M. Muñoz, Adrian Trenholme, Eric A. F. Simões, Geeta K. Swamy, Sapeckshita Agrawal, Khatija Ahmed, Allison August, Abdullah H Baqui, Anna Calvert, Janice Chen, Iksung Cho, Mark F. Cotton, Clare Cutland, Janet A. Englund, Amy Fix, Bernard Gonik, Laura L. Hammitt, Paul T. Heath, Joanne N. de Jesus, Christine E. Jones, Asma Khalil, David W. Kimberlin, Romina Libster, Conrado J. Llapur, Marilla Lucero, Gonzalo Pérez Marc, Helen Marshall, Masebole Masenya, Federico Martinón‐Torres, Jennifer K. Meece, Terry Nolan, Ayman Osman, Kirsten P. Perrett, Joyce S. Plested, Peter Richmond, Matthew D. Snape, Julie H. Shakib, Vivek Shinde, Tanya Stoney, D. Nigel Thomas, Alan Tita, Michael W. Varner, Manu Vatish, Keith Vrbicky, Judy Wen, Khalequ Zaman, Heather J. Zar, Gregory M. Glenn, Louis Fries
Abstract
RSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The suggestion of a possible benefit with respect to other end-point events involving RSV-associated respiratory disease in infants warrants further study. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov NCT02624947.).
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