Novavax initiates Phase 3 clinical trial for NanoFlu
Novavax 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. 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 and licensure of NanoFlu using the U.S. Food and Drug Administration's 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. The trial will enroll approximately 2,650 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 titers of vaccine homologous influenza strains compared to a licensed seasonal vaccine, and to describe its safety profile.