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NOVAVAX Presents Final Results from H1N1 Influenza Vaccine Trial at World Health Organization Meeting
Date:2/18/2011

to 85% of subjects which indicates that the VLP vaccine will be important in addressing future influenza pandemics.  Novavax VLPs are unique as they are made in a non-egg-based, recombinant manufacturing system that produces particles resembling the influenza virus but which renders them more immunogenic than simple recombinant vaccines."

Methods

This Phase II randomized, double-blind, placebo-controlled trial was conducted at a single study center in Mexico to evaluate the safety, tolerability, and immunogenicity of 3 dose levels (5mcg, 15mcg, and 45mcg HA) of the novel (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults aged 18 to 64 years.  The study was conducted in two parts: Part A was to evaluate the safety and immunogenicity of the H1N1 influenza VLP vaccine over a dose range and to select a dose for an expanded safety evaluation in Part B. In Part A, 1,013 subjects were enrolled (760 active and 253 placebo). Based on an interim safety and immunogenicity analysis, an additional 3,547 (2,535 active and 1,012 placebo) subjects were enrolled in Part B of the study, a safety only study, and received 15mcg of VLP vaccine or placebo as a single injection on Day 1 using a second lot of H1N1 VLP vaccine.

Safety

In Part A, adverse events (AEs) were similar for the placebo group and for the active vaccine groups, except that dose-related local injection site reactions were reported more frequently in the active vaccine groups.  In Part B of the study, the incidence of AEs was consistent with that of Part A and was comparable between the VLP and placebo groups.  The results for the 15mcg vaccine in Part A and Part B of the study demonstrated that the different vaccine lots exhibited comparable safety profiles.  Across all subjects in Part A and Part B, the majority of AEs were of mild or moderate severity and resolved without sequelae and all serious AEs were considered defin
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SOURCE Novavax, Inc.
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