Business
Novavax Initiates Pivotal Phase 3 Clinical Trial of NanoFlu Influenza Vaccine in Older Adults
First participants enrolled in pivotal Phase 3 clinical trial of NanoFlu Top-line clinical data expected in the first quarter of 2020 Phase 3 results expected
About this update from Novavax, Inc.
[{"type":"text","content":"First participants enrolled in pivotal Phase 3 clinical trial of NanoFlu Top-line clinical data expected in the first quarter of 2020 Phase 3 results expected to support a future BLA and licensure of NanoFlu using the FDA’s accelerated approval pathway GAITHERSBURG, Md., Oct. 15, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of a pivotal 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 U.S.-licensed quadrivalent influenza vaccine.\n 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 U.S. biologics license application (BLA) and licensure of NanoFlu using the U.S. Food and Drug Administration’s (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 U.S. 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 ...