Novavax, Inc. (Nasdaq: NVAX) today presented to the world's leading pandemic influenza vaccine experts a summary of the recent preliminary safety and immunogenicity data from its Pivotal 2009 A/H1N1 VLP pandemic influenza vaccine study in Mexico. The presentation of the results were made by Maria Allende, M.D., at the invitation-only 6th World Health Organization (WHO) Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials, held at the WHO headquarters in Geneva, Switzerland. The presentation is available at www.novavax.com under the Investors/Events tab.
In this study, 1,000 healthy volunteers aged 18 to 64 years old were enrolled to receive two doses of 5 mcg, 15 mcg or 45 mcg of Novavax's 2009 H1N1 influenza VLP or a placebo to determine the safety and immunogenicity of the vaccine. Preliminary results at Day 14 after a single dose of Novavax's 2009 H1N1 VLP pandemic influenza vaccine from approximately 500 subjects showed that the vaccine was well tolerated at all three dose levels and exhibited no systemic side effects and mostly mild local site reactions, similar to placebo. After only one dose of either 5 mcg, 15 mcg or 45 mcg in these volunteers, the vaccine achieved robust serological immune responses that are considered protective. These preliminary data indicate that a single dose of 15 mcg appears to be optimal to induce robust immune responses in broader age populations with a highly satisfactory safety profile. This dose has been selected for continuation into the second stage or Stage B of this trial.