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The Phase II trial is a randomized, placebo-controlled, observer-blinded study that will include patients aged 18 to 84 years.
Novavax announced on August 24, 2020 that it has initiated the Phase II portion of its clinical trial to assess the immunogenicity and safety of NVX-CoV2373, its COVID-19 vaccine candidate.
According to a company press release, the Phase II trial is a randomized, placebo-controlled, observer-blinded study that will include patients aged 18 to 84 years. It will feature two dose sizes (5 and 25 µg), each with 50 µg of Matrix‑M.
The Phase I portion of the clinical trial yielded positive results and antibody responses numerically superior to that seen in human convalescent sera, the press release said.
“We expect this Phase II portion of the trial to expand on the encouraging Phase I safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults,” said Gregory M. Glenn, MD, president, Research and Development at Novavax, in the press release. “Our Phase III trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year.”