Phase 3 Pivotal Trial of NanoFlu™ in Older Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: NanoFlu; Fluzone Quadrivalent
Intervention description: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.; Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2654.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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 were formulated with the 4 influenza
      strains recommended for the 2019-20 Northern hemisphere influenza season. 2654 subjects were
      enrolled and randomized into 1 of 2 treatment groups to receive either NanoFlu or active
      comparator. Subjects were followed for approximately 1 year following injection; with primary
      immunogenicity analyses based on Day 28 sera. This trial was conducted in the United States
      at approximately 19 clinical sites.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinically-stable adult male or female, ≥ 65 years of age. Subjects may have 1 or more
             chronic medical diagnoses, but should be clinically stable as assessed by:

               -  Ambulatory status, living independently in the community or in a residential
                  facility providing minimal assistance (eg, meal preparation and transport),

               -  Absence of changes in medical therapy within 1 month due to treatment failure or
                  toxicity,

               -  Absence of medical events qualifying as serious adverse events within the prior 2
                  months, and

               -  Absence of known, current, and life-limiting diagnoses which render survival to
                  completion of the protocol unlikely in the opinion of the investigator.

          2. Willing and able to give informed consent prior to trial enrollment, and

          3. Living in the community and able to attend trial visits, comply with trial
             requirements, and provide timely, reliable, and complete reports of adverse events.

        Exclusion Criteria:

          1. Participation in research involving investigational product (drug / biologic / device)
             within 45 days before planned date of study vaccination.

          2. Participation in any previous Novavax influenza vaccine clinical trial(s).

          3. History of a serious reaction to prior influenza vaccination, known allergy to
             constituents of Fluzone Quadrivalent or polysorbate 80.

          4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza
             vaccine.

          5. Received any vaccine in the 4 weeks preceding the trial vaccination and any influenza
             vaccine within 6 months preceding the trial vaccination.

          6. Any known or suspected immunosuppressive illness, congenital or acquired, based on
             medical history and/or physical examination.

          7. Chronic administration (defined as more than 14 continuous days) of immunosuppressants
             or other immune-modifying drugs within 6 months prior to the administration of the
             trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a
             systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical,
             inhaled, and nasal glucocorticoids will be permitted.

          8. Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the administration of the trial vaccine.

          9. Acute disease at the time of enrollment (defined as the presence of a moderate or
             severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned
             day of vaccine administration).

         10. Any condition that in the opinion of the investigator would pose a health risk to the
             subject if enrolled or could interfere with evaluation of the vaccine or
             interpretation of trial results (including neurologic or psychiatric conditions deemed
             likely to impair the quality of safety reporting).

         11. Known disturbance of coagulation.

         12. Suspicion or recent history (within 1 year of planned vaccination) of alcohol or other
             substance abuse.