Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants
SA Madhi, FP Polack, PA Piedra, FM Munoz, AA Trenholme, EAF Simoes, GK Swamy, S Agrawal, K Ahmed, A August, AH Baqui, A Calvert, J Chen, I Cho, MF Cotton, CL Cutland, JA Englund, A Fix, B Gonik, L Hammitt Show all
New England Journal of Medicine | MASSACHUSETTS MEDICAL SOC | Published : 2020
BACKGROUND: Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants. METHODS: Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significan..View full abstract
Supported by Novavax and by a grant from the Bill and Melinda Gates Foundation.