NanoFlu is a vaccine candidate which is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced in an Sf9 insect cell-baculovirus system.
NanoFlu uses HA protein amino acid sequences that are the same as the recommended wild-type virus HA sequences.
NanoFlu contains Novavax’s patented saponin-based Matrix-M adjuvant, which is potent, well-tolerated and stimulates both high quality and durable antibody responses as well as multifunctional CD4 and CD8 T-cell responses.
NanoFlu is indicated to prevent serious disease caused by influenza in older adults.
NanoFlu is administered as an intramuscular injection in the clinical trials
October 15, 2019: Novavax, Inc 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.
August 5, 2019: Novavax Reaches Agreement with the FDA on Pivotal Phase 3 Trial Design for NanoFlu
January 03, 2019: Novavax announced Positive Phase 2 NanoFlu Results in Older Adults.
Clinical Trial NCT04120194: Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
- A Phase 3, randomized, observer-blinded, active-controlled trial to evaluate the immunogenicity and safety of a recombinant quadrivalent nanoparticle influenza vaccine with Matrix-M1 adjuvant (NanoFlu) compared with a licensed quadrivalent inactivated influenza vaccine in adults ≥ 65 years of age.
- Both vaccines will be formulated with the 4 influenza strains recommended for the 2019-20 Northern hemisphere influenza season.
- Approximately 2650 subjects (1325 subjects/group) will be enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active comparator.
- Subjects will be followed for approximately 1 year following injection; with primary immunogenicity analyses based on Day 28 sera.
- This trial will be conducted in the United States at approximately 19 clinical sites.
Clinical Trial NCT03293498: Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)
- This is a Phase 1/2, randomized, observer-blinded, active-controlled trial.
- The trial compared the safety and immune responses of various quadrivalent formulations of NanoFlu, with or without Novavax’ Matrix-M™ adjuvant, with two U.S.-licensed influenza vaccines in 1,375 healthy adults 65 years of age and older.
- Approximately 330 eligible subjects will be enrolled and randomized into 1 of 3 treatment groups as shown in the Trial Design table below.
- Each group will consist of approximately 110 subjects total, stratified by age, gender, and history of receipt of 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B will be administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C will receive the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and volume.
- On Day 21, all Group A and B subjects will be administered a rescue injection with a licensed seasonal influenza vaccine, while all Group C subjects will be administered an injection with sterile saline placebo to maintain trial blind.
- Trial follow-up for each subject will span approximately 1 year from Day 0.