Novavax (NVAX) Commences Enrollment in Quadrivalent Seasonal VLP Phase II
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Novavax, Inc. (Nasdaq: NVAX) announced that it has begun enrollment in a Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate. This randomized, observer-blind, comparator-controlled study is being conducted in multiple centers in Australia under the company's contract with the U.S. Department of Health and Human Services' Office of Biomedical Advanced Research and Development Authority (BARDA) to develop recombinant vaccines for the prevention of seasonal and pandemic influenza. The trial will evaluate the immunogenicity and safety of three dose levels of Novavax's quadrivalent seasonal recombinant VLP influenza vaccine in healthy adults between the ages of 18 and 64.
The Phase II trial will enroll up to 500 eligible subjects who will be randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants will receive a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax vaccine or a standard dose of a licensed trivalent vaccine. Study participants will be evaluated at day 21 for hemagglutination inhibition (HAI) response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.
Novavax expects to evaluate the top-line data from this Phase II trial in the third quarter of 2012.
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The Phase II trial will enroll up to 500 eligible subjects who will be randomized into five treatment groups of approximately 100 subjects stratified by age and receipt of influenza immunization in the 2011 season. At day zero, study participants will receive a single intramuscular vaccine injection of the quadrivalent vaccine containing one of three ascending doses or one of two trivalent comparators: Novavax vaccine or a standard dose of a licensed trivalent vaccine. Study participants will be evaluated at day 21 for hemagglutination inhibition (HAI) response and safety and tolerability of the vaccine; additional safety and immune response follow-up will continue with the subjects through six months.
Novavax expects to evaluate the top-line data from this Phase II trial in the third quarter of 2012.
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