A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: aQIV; Comparator QIV
Intervention description: Participants receive a 0.5-mL intramuscular dose of aQIV on Day 1; Participants receive a 0.5-mL intramuscular dose of Comparator QIV on Day 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2044.0
Sex: All
Minimum age: 50 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, Vaccine, MF59 adjuvant

Summary:

      This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV
      (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent
      influenza vaccine in adults 50 to 64 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

        In order to participate in this study, all subjects must meet ALL of the following
        inclusion criteria:

          -  Individuals 50 to 64 years of age (i.e. 50 to ≤64 years) on the day of informed
             consent

          -  Individuals who have voluntarily given written consent after the nature of the study
             has been explained according to local regulatory requirements, prior to study entry

          -  Individuals who can comply with study procedures including follow-up

          -  Males, females of non-childbearing potential or females of childbearing potential who
             are using an effective birth control method, at least 30 days prior to informed
             consent, which they intend to use for at least 2 months after the study vaccination

        Exclusion Criteria:

        In order to participate in this study, all subjects must not meet ANY of the exclusion
        criteria described below:

          -  Females of childbearing potential who are pregnant, lactating, or who have not adhered
             to a specified set of contraceptive methods from at least 30 days prior to study entry
             and who do not plan to do so until 2 months after the study vaccination

          -  Progressive, unstable or uncontrolled clinical conditions

          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products
             or medical equipment whose use is foreseen in this study

          -  History of any medical condition considered an AESI

          -  Known history of Guillain Barré syndrome or another demyelinating disease such as
             encephalomyelitis and transverse myelitis

          -  Clinical conditions representing a contraindication to intramuscular vaccination and
             blood draws

          -  Abnormal function of the immune system resulting from:

               1. Clinical conditions

               2. Systemic administration of corticosteroids (PO/IV/IM) at a dose equivalent to ≥20
                  mg/day of prednisone for more than 14 consecutive days within 90 days prior to
                  informed consent. Topical, inhaled and intranasal corticosteroids are permitted.
                  Intermittent use (one dose in 30 days) of intra-articular corticosteroids is also
                  permitted

               3. Administration of antineoplastic and immunomodulating agents or radiotherapy
                  within 90 days prior to informed consent

          -  Received immunoglobulins or any blood products within 180 days prior to informed
             consent

          -  Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent, or who are unwilling to refuse participation in another clinical
             study at any time during the conduct of this study (notes: i. concomitant
             participation in a study not involving or no longer involving administration of drugs,
             vaccines, or medical devices, is acceptable (e.g. studies in safety follow-up phase,
             observational studies); ii. concomitant participation in a COVID-19 vaccine study is
             acceptable provided that the vaccine dosing interval mentioned in Exclusion Criterion
             #11 is adhered to)

          -  Receipt of any influenza vaccine within 6 months prior to enrollment in this study, or
             plan to receive influenza vaccine during the study period

          -  Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days
             (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or
             plan to receive any COVID-19 vaccine within 7 days from study vaccination

          -  Receipt of any inactivated non-influenza vaccine within 14 days or live-attenuated
             vaccine within 28 days prior to enrollment in this study or plan to receive any other
             non-influenza vaccine within 28 days from study vaccination

          -  Acute (severe) febrile illness

          -  Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study

          -  Study personnel or immediate family members or household member of study personnel