Health technology assessment : HTA
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Health Technol Assess · Dec 2010
Randomized Controlled Trial Multicenter StudyA randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart.
To evaluate the immunogenicity of a two-dose schedule of Baxter cell-cultured, non-adjuvanted, whole-virion H1N1 vaccine, and GlaxoSmithKline AS03(A)-adjuvanted split-virion H1N1 vaccine with respect to the EU Committee for Medicinal Products for Human Use (CHMP) and the US Food and Drug Administration (FDA) licensing criteria. ⋯ AS03(A)-adjuvanted 2009 H1N1 vaccine is more immunogenic and provides greater antigen-sparing capacity than WV 2009 H1N1 vaccine.