Vaccine Info

NanoFlu Influenza Vaccine

Description

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.

Indication

NanoFlu is indicated to prevent serious disease caused by influenza in older adults.

Dosage

NanoFlu is administered as an intramuscular injection in the clinical trials

Updates

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 Trials

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.

 

Updated
October 15th, 2019