Novavax’ NanoFlu Achieves All Primary Endpoints In Phase 3 Clinical Trial
- Trial also achieves statistical significance in key secondary endpoints
Novavaxto submit a U.S.BLA under FDA’s accelerated approval pathway
- Company to host investor conference call today at
8:30 a.m. EDT
NanoFlu Phase 3 Primary Objectives
The trial’s primary objectives were to demonstrate non-inferior immunogenicity of NanoFlu compared to Fluzone Quadrivalent using the day 28 ratio of geometric mean titers (GMT) and the difference in seroconversion rates (SCR), as well as the overall safety of NanoFlu. Immunogenicity was measured by hemagglutination inhibition (HAI) assays using egg-derived reagents.
- NanoFlu achieved the primary endpoints, both GMT and SCR, for all four strains included in the vaccine.
- NanoFlu was well-tolerated and had a safety profile comparable to Fluzone Quadrivalent with a modest increase in local adverse events (AEs).
“With these data, we now have a clear path forward to licensure with our differentiated recombinant influenza vaccine,” said
NanoFlu Phase 3 Secondary Objectives
The trial’s key secondary endpoints assessed GMT and SCR, but with an HAI assay based on wild-type reagents, which are expected to provide a more accurate assessment of clinically relevant HAI antibody responses against circulating wild-type viruses.
- NanoFlu demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent across all four strains included in the vaccine.
- 24%-66% higher GMT responses; and
- 11.4-20.4 higher SCR percentage points.
- NanoFlu also demonstrated significantly higher GMT and SCR than Fluzone Quadrivalent for four tested drifted H3N2 strains not included in the vaccine but circulating this year.
- 34%-41% higher GMT responses; and
- 14.1-16.8 higher SCR percentage points
“In addition to meeting the primary objectives, we are very pleased to report that NanoFlu also met or exceeded its secondary endpoints for all four strains using our proprietary HAI assay based upon wild-type reagents,” said
Webcast Conference Call
A replay of the webcast will be available on the
About Phase 3 Clinical Trial
The trial enrolled 2,652 healthy older adults across 19 U.S. clinical sites. Trial participants received either NanoFlu or the comparator, both of which were 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.
About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
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Source: Novavax, Inc.