Novavax, Inc. a clinical-stage vaccine company, has released the final results from a Phase II clinical trial evaluating Novavax’s trivalent seasonal influenza Virus-like particle (VLP) vaccine candidate in healthy adults. The study enrolled healthy volunteers 18 to 49 years in age who were immunized with a single injection of Novavax’s trivalent seasonal influenza VLP vaccine matched to the influenza strains recommended for the 2008-2009 influenza vaccine.
Preliminary data from this trial were reported in 2009.
The complete analysis included 232 volunteers in total; with 49 receiving placebo, 83 given Novavax’s trivalent seasonal influenza VLP vaccine at 15 mcg/dose, 81 injected with Novavax’s trivalent seasonal influenza VLP vaccine at 60 mcg/dose and 19 volunteers receiving an inactivated trivalent influenza vaccine Fluzone (TIV) at 15 mcg/dose. The three strains were H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006. The data show that Novavax’s trivalent seasonal influenza VLP vaccine induced a robust hemagglutination inhibition (HAI) antibody response against all three strains in the vaccine. Seroconversion rates as defined by the FDA (including lower and upper 95% Confidence Intervals (CI)) for the 15 mcg group were as follows: 51% (39, 62), 76% (65, 85), and 58% (47, 69) against the H1N1, H3N2, and B strains, respectively. Seroprotection (titer greater than or equal to 1:40) rates for volunteers in the 15 mcg group (with 95% CIs) were 70% (59, 80), 89% (80, 94), and 84% (75, 91) against the H1N1, H3N2, and B strains,
