Novavax Initiates Phase 2 Clinical Trial of NanoFlu™ in Older Adults
- First participants enrolled in Phase 2 clinical trial of quadrivalent NanoFlu formulations
- Top-line immunogenicity and safety data expected in the first quarter of 2019
- Phase 2 results will support meeting with the
U.S. Food and Drug Administration( FDA) and Phase 3 clinical trial design
“Initiating this Phase 2 clinical trial of NanoFlu is an important milestone for Novavax,” said
This randomized, observer-blinded, active-controlled trial will assess the safety and tolerability of different doses and formulations of NanoFlu, both adjuvanted with its proprietary Matrix-M™ adjuvant and unadjuvanted, as compared to two U.S.-licensed comparators. The trial will enroll approximately 1,375 healthy older adults across clinical sites in the U.S. and is designed to select a dose/formulation of NanoFlu that
“The dual problems of antigenic drift and antigenic changes resulting from egg-based vaccine production have, in recent years, resulted in generally poor influenza vaccine effectiveness with potentially severe medical consequences, particularly in older adults. A substantially improved seasonal influenza vaccine is a widely recognized, high-priority unmet medical need,” said
More information about the newly initiated trial can be found at www.clinicaltrials.gov.
Previously Reported Phase 1/2 Clinical Trial Results with NanoFlu
- Hemagglutination inhibition (HAI) immune responses that were 28% to 64% greater against the homologous and four generations of drifted wild-type A(H3N2) influenza strains;
- Higher HAI responses against the homologous A(H1N1) strain and comparable responses against the homologous B/
- Strong neutralizing antibody responses that correlate with HAI results.
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as infants, young children and older adults, but also in the general population largely because of infection by continuously evolving strains of influenza which can evade the existing protective antibodies in humans. An estimated one million deaths globally each year are attributed to influenza.1 Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S.,
1 Resolution of the
2 Influenza Vaccines Forecasts. Datamonitor (2013)
About NanoFlu™ and Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by
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 to predict clinical benefit. For seasonal influenza vaccines, the hemagglutination inhibition (HAI) antibody response may be an acceptable surrogate marker of activity that is reasonably likely to predict clinical benefit. To be considered for accelerated approval, a biologics license application for a new seasonal influenza vaccine should include results from one or more well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies of clinical effectiveness in preventing influenza.
Statements herein relating to the future of
Senior Manager, Investor & Public Relations
Source: Novavax, Inc.