id	author	title	date	pages	extension	mime	words	sentences	flesch	summary	cache	txt
cord-012509-887xlllb	Roy-Ghanta, Sumita	Responses to A(H1N1)pdm09 Influenza Vaccines in Participants Previously Vaccinated With Seasonal Influenza Vaccine: A Randomized, Observer-Blind, Controlled Study	2014-11-01		.txt	text/plain	5174	274	52	We investigated the effect of TIV priming on humoral responses to AS03-adjuvanted and nonadjuvanted A(H1N1)pdm09 vaccines, the role of AS03 on cell-mediated immune (CMI) responses, and vaccine safety. Healthy adults (aged 19–40 years) were randomized 1:1:1:1 to receive TIV or saline followed 4 months later by 2 doses, 3 weeks apart, of adjuvanted or nonadjuvanted A(H1N1)pdm09 vaccine and followed up to study end (day 507). Assessment of HI responses was based on the European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) guidance targets for pandemic influenza vaccines in adults [32] (point estimates, SCR >40%; SPR >70%; GMFR >2.5) and the Center for Biologics Evaluation and Research (CBER) licensure criteria [33] [lower limits of 95% confidence interval (CI) ≥40% for SCR and ≥70% for SPR]. After TIV or placebo administration (dose 1; days 0-122), GMTs of A(H1N1)pdm09-specific HI responses in both groups remained low (ranges, 12.5-19.9 and 13.3-13.9, respectively), and CHMP or CBER criteria were not met (Supplementary Table 1) .	./cache/cord-012509-887xlllb.txt	./txt/cord-012509-887xlllb.txt