Novavax has initiated a Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged 65 and over.
The trial, for which the first participants have been enrolled, will evaluate the immunogenicity and safety of NanoFlu with its proprietary Matrix-M adjuvant, compared to a US-licensed quadrivalent influenza vaccine.

Top-line clinical data from the randomized, observer-blinded, active-controlled trial is expected in the first quarter of 2020 and would support a subsequent US biologics license application (BLA) and licensure of NanoFlu using the US FDA accelerated approval pathway. This pathway enables Novavax to conduct this non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.

“This is an important step forward in Novavax’ efforts to gain approval for NanoFlu, which we believe will better protect older adults from the serious medical complications of influenza through our novel vaccine technology,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “With current vaccine efficacy at 12 percent in older adults, NanoFlu may address a major unmet need that represents a $4 billion market globally.”

The trial will enroll approximately 2,650 (1,325 per arm) healthy older adults across 19 US clinical sites. Trial participants will receive either NanoFlu or the comparator, both of which will be formulated with the four influenza strains recommended for the 2019-2020 Northern hemisphere influenza season. Participants will be followed for approximately one year after injection, with primary immunogenicity analyses of the Day 28 sera samples.

The trial’s primary objective is to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to a licensed seasonal vaccine, and to describe its safety profile.

“We believe that NanoFlu represents a significant advance in influenza vaccine development and could provide meaningful advantages in protecting older adults against influenza,” said Gregory Glenn, MD, President of Research and Development of Novavax. “We have shown that NanoFlu, a Matrix-M adjuvanted recombinant nanoparticle, elicits antibodies that neutralize the predicted circulating viruses, historic circulating viruses, and the newly evolved H3N2 viruses. In addition, the induction of robust flu specific effector T cells in older adults further distinguishes NanoFlu from licensed comparators. We expect that the use of accelerated approval pathway will make this needed vaccine available to the public sooner. ”