id author title date pages extension mime words sentences flesch summary cache txt cord-002333-90f9vr0a Madan, Anuradha Immunogenicity and Safety of an AS03-Adjuvanted H7N9 Pandemic Influenza Vaccine in a Randomized Trial in Healthy Adults 2016-12-01 .txt text/plain 4250 210 46 The coprimary immunogenicity objective determined whether adjuvanted vaccines elicited an immune response against the vaccine-homologous virus, 21 days after the second vaccine dose per US and European licensure criteria in the per-protocol cohort (n = 389). The coprimary immunogenicity objective was to evaluate whether the adjuvanted A/Shanghai/2/2013 (H7N9) vaccines elicited an immune response against the vaccine-homologous virus that met US CBER and European Committee for Medicinal Products for Human Use (CHMP) immunogenicity targets at day 42 (21 days after the second vaccine dose). In a sub-analysis of the homologous immune response by age, the adjuvanted vaccine was immunogenic in both age groups, with SPRs ≥80.0% in participants 41-64 years of age, despite lower GMTs (Table 3 ). The results of this phase I/II randomized, placebo-controlled trial showed that 2 doses of the H7N9 AS03-adjuvanted vaccine elicited a robust immune response in healthy adults up to 64 years of age, with an acceptable safety profile. ./cache/cord-002333-90f9vr0a.txt ./txt/cord-002333-90f9vr0a.txt