Novavax has started vaccination of healthy volunteers in a Phase II clinical trial of its virus-like particle based seasonal influenza vaccine.
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The Phase IIa randomized, placebo controlled clinical trial will evaluate the safety and immunogenicity of different doses of its seasonal influenza virus-like particle (VLP) vaccine.
Specifically, the vaccine will be studied in approximately 300 healthy adults between the ages of 18 to 49 years, who will receive a single injection of either a placebo or an influenza vaccine at doses of 5mcg, 15mcg or 30mcg.
The goals of the study are to select a dose for evaluation in a subsequent Phase III efficacy study and to continue the evaluation of safety of its novel influenza VLP vaccines.
Rahul Singhvi, president and CEO of Novavax, said: “VLPs are a very promising approach against influenza as we recently demonstrated with the announcement of favorable results in a Phase IIa human clinical trial of our VLP based pandemic influenza vaccine. There are synergies to be gained in the development of our VLP pandemic and seasonal influenza vaccines that provide the company unique advantages.”
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