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ContextA high priority in vaccine research is the development of influenza vaccines that do not use embryonated eggs as the substrate for vaccine production.ObjectiveTo determine the dose-related safety, immunogenicity, and protective efficacy of an experimental trivalent influenza virus hemagglutinin (rHA0) vaccine produced in insect cells using recombinant baculoviruses.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled clinical trial at 3 US academic medical centers during the 2004-2005 influenza season among 460 healthy adults without high-risk indications for influenza vaccine.InterventionsParticipants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 μg of an rHA0 vaccine containing 15 μg of hemagglutinin from influenza A/New Caledonia/20/99(H1N1) and influenza B/Jiangsu/10/03 virus and 45 μg of hemagglutinin from influenza A …