Novavax, Inc. (NVAX) said it has begun a Phase IIa clinical study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older.
According to the company, the current trial is a Phase IIa randomized, double-blind, active-controlled study to evaluate the safety, tolerability and immunogenicity of the trivalent seasonal influenza VLP at 15 mcg and 60 mcg per strain in healthy adults who are 60 years of age or older. The safety and immunogenicity of the influenza VLP vaccine at these two dose levels will also be compared with that of a commercially available inactivated trivalent seasonal influenza vaccine, TIV, administered at the standard dose of 15 mcg of HA per strain. A total of 480 subjects will be enrolled, in a 1:1:1 randomization schedule at approximately six sites in the United States and one site in India.
In addition to evaluating hemagglutinin inhibition responses, anti-neuraminidase and cell-mediated immune responses will also be examined.
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