A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: M-001; Saline
Intervention description: A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.; 0.9% sodium chloride (NaCl)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: All parties are blinded except for the person who prepares the syringe for injection. The M-001 is cloudy white and its appearance is different from the transparent saline that is used for placebo. The person prepares the syringe with an opaque sticker that fully covers the syringe contents. People administering the syringe are not involved or present during syringe preparation, and are thus fully blinded.
Enrollment: 12460.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; vaccine; universal; M-001; Multimeric-001; Flu

Summary:

      The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged
      50+ over two years. Participants will be immunized twice with the M-001 universal influenza
      vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate
      the number of influenza cases in each group and the severity of illness during the follow up
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects 50 years of age (inclusive) or older, mentally competent,
             willing and able to give the written informed consent prior to study entry

          2. Able to comply with the trial procedures and be available for all study visits.

          3. Medically stable. (Subjects may have underlying chronic conditions such as
             hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their
             symptoms/signs are controlled. If they are on medication for a condition, the
             medication dose must have been stable for at least 3 months preceding vaccination).

          4. Women of childbearing potential (not surgically sterile or postmenopausal for greater
             than or equal to one year) and men must agree to practice adequate contraception
             (barrier or hormone methods or intra uterine device (IUD) for women and a condom for
             men) throughout the study treatment and for at least up to day 51 (for female) and day
             111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the
             last dose of the IMP)

          5. Female subjects of childbearing potential must have a negative urine or serum
             pregnancy test within 24 hours prior to study vaccination.

        Exclusion Criteria:

          1. History of neurological symptoms or signs, or anaphylactic shock following
             administration of any vaccine.

          2. Known or suspected (or have a high risk of developing) impairment/alteration of immune
             function (excluding that normally associated with advanced age).

          3. Receipt of: a) Immunosuppressive drugs: i) systemic glucocorticoids >/= 10 mg
             prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before,
             or planned during, the study c) Blood products within 3 months before, or planned
             during, the study d) Influenza vaccine within 6 months before the study) Other
             vaccines within 30 days before, or planned during, the study

          4. Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic
             disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD)
             that requires oxygen therapy, acute or progressive hepatic disease, acute or
             progressive renal disease, or congestive heart failure, as judged by the PI.

          5. An acute illness, including an axillary temperature greater than 38 Celsius (38ºC),
             occurred within 1 week before first vaccination

          6. Positive positive urine pregnancy test prior to vaccination or women who are
             breastfeeding.