Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: NanoFlu (Quad-NIV); Matrix-M Adjuvant; Placebo; Fluzone HD; Flublok Quadrivalent; Influenza Vaccine
Intervention description: 2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine; Adjuvant; Placebo; 2018-2019 Licensed Trivalent Seasonal Influenza Vaccine; 2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine; 2018-19 Licensed Seasonal Influenza Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1375.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2 trial to confirm the dose and formulation, demonstrate adjuvant effect, and
      evaluate the safety and tolerability of a single intramuscular injection of Quad-NIV with or
      without Matrix-M1 adjuvant in healthy adults ≥ 65 years of age.

      A total of approximately 1375 subjects were to be randomized to seven treatment groups to
      receive Quad-NIV or an active comparator.
    

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:

               -  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 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 first injection.

          2. Participation in any previous Novavax's influenza vaccine clinical trial(s).

          3. History of a serious reaction to prior influenza vaccination, known allergy to
             constituents of licensed comparator vaccines 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 or during the trial.

          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.