id author title date pages extension mime words sentences flesch summary cache txt cord-282158-08u3x1z4 Yang, William H. Long-term immunogenicity of an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine in young and elderly adults: An observer-blind, randomized trial() 2013-09-13 .txt text/plain 5295 252 49 This large-scale, randomized study in subjects ≥18 years of age assessed whether one dose of AS03-adjuvanted 3.75 g HA influenza A(H1N1)pdm09 vaccine elicited immune response that met the US and European regulatory criteria. A single dose of the AS03-adjuvanted 3.75 g HA influenza A(H1N1)pdm09 vaccine elicited HI immune responses in the 18-64 years and >64 years age groups that met the CBER regulatory criteria at Day 21 ( Table 1 ). At Day 21, a single dose of the non-adjuvanted 15 g HA influenza A(H1N1)pdm09 vaccine elicited HI immune responses in subjects 18-64 years and >64 years of age that met the CBER regulatory criteria (Table 1) . Data from this large, controlled study in adults 18 years of age and older demonstrated that a single dose of AS03-adjuvanted or non-adjuvanted influenza A(H1N1)pdm09 vaccine elicited strong HI immune responses 21 days later that met the CHMP and the more stringent CBER criteria for pandemic influenza vaccines. ./cache/cord-282158-08u3x1z4.txt ./txt/cord-282158-08u3x1z4.txt