Date: 2017-09-19
Type of
information: Recruitment of the first patient
phase: 1-2
Announcement: recruitment of the first patient
Company: Novavax (USA - MD)
Product: NanoFlu™ vaccine
Action
mechanism:
- vaccine. This seasonal influenza vaccine candidate is based on the 2017-2018 World Health Organization (WHO) recommended influenza strains. Data from a preclinical study of this nanoparticle influenza vaccine candidate with Novavax's proprietary Matrix-M™ adjuvant (NanoFlu™) have been published in Vaccine. The study, conducted in ferrets, found that NanoFlu induced hemagglutination-inhibition (HAI) and microneutralizing (MN) antibodies against a broad range of influenza subtypes.
Disease: influenza
Therapeutic
area: Infectious diseases
Country:
Trial
details:
- 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).
Latest
news:
- • On September 19, 2017, Novavax announced the enrollment of the first participant in a Phase 1/2 clinical trial of its nanoparticle influenza vaccine candidate including its proprietary Matrix-M™ adjuvant (NanoFlu™) in older adults. “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 Gregory Glenn, M.D., President of Research and Development. “We will evaluate immunogenicity using HAI titers, which are the industry standard and an established surrogate marker of protection. Data from this trial may provide the basis to request accelerated approval for initial licensure of our NanoFlu vaccine.
Is
general: Yes
