Novavax Initiates Phase 1/2 Trial of NanoFlu™ Vaccine in Older Adults
- Recently published NanoFlu™ preclinical data provide strong rationale for Phase 1/2 clinical trial based on robust antibody titers and improved protective responses against both current and drifted strains
- Data from trial expected by the end of 2017
The trial is a randomized, observer-blinded, active comparator-controlled trial in approximately 330 healthy older adults. The primary objective of the trial is to assess the safety and immunogenicity of two concentrations (15 µg or 60 µg) of NanoFlu compared to a licensed influenza vaccine, Fluzone® High-Dose (Fluzone HD).
“The trial is designed to identify an immune response, characterized by hemagglutination-inhibiting (HAI) and neutralizing antibodies, that is similar to or better than Fluzone HD,” said
"Our recent preclinical data further indicate NanoFlu elicits improved protective responses against drifted strains, which could be a key differentiating factor of the vaccine. Current influenza vaccine protection is typically limited to strain-specific immune responses. Strain mismatch or antigenic drift between seasonal vaccines and circulating influenza strains can lead to reduced protection.”
“The data described in our recent Vaccine publication provided strong rationale for advancing our NanoFlu program into the clinic,” said
About Accelerated Approval
Accelerated approval may be granted for certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments.
Such an approval will be based on adequate and well-controlled clinical trials establishing that the biological product has an effect on a surrogate endpoint that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit. More information on accelerated approval can be found here: https://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm074794.htm
1. Average of 3 past seasons, 2010-2013; includes vaccine averted cases. C. Reed et al. Estimating Influenza Disease Burden from Population-Based Surveillance Data in
2. PharmaPoint Seasonal Influenza Vaccines Global Drug Forecast and Market Analysis to 2025,
Statements herein relating to the future of
Source: Novavax, Inc.