Study of a Quadrivalent High-Dose Influenza Vaccine and a Moderna COVID-19 Vaccine Administered Either Concomitantly or Singly in Participants 65 Years of Age and Older Previously Vaccinated With a 2-dose Schedule of Moderna COVID-19 Vaccine
Condition: Influenza Immunization; Healthy Volunteers
MeSH terms: Influenza, Human
Intervention: Quadrivalent Inactivated Influenza High Dose; COVID-19 mRNA Vaccine (nucleoside modified)
Intervention description: Sterile suspension for injection in a pre-filled syringe Intramuscular injection; Sterile suspension (white to off-white) in multidose vial Intramuscular injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 306.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this Phase II study was to assess the safety and immunogenicity of a dose
      of Fluzone High-Dose (HD) Quadrivalent vaccine and a third dose or booster dose of Moderna
      coronavirus disease 19 (COVID-19) vaccine administered concomitantly or singly in adults 65
      years of age and older having received their second dose of the 2-dose schedule of Moderna
      COVID-19 vaccine at least 5 months before enrollment in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged greater than or equal to >= 65 years of age on the day of inclusion.

          -  In good health or with underlying medical condition(s) that were judged to be stable
             by the Investigator. A stable medical condition was defined as disease not requiring
             significant change in therapy or hospitalization for worsening disease during the 3
             months before enrollment.

          -  Participants who previously received 2 injections of Moderna COVID-19 Vaccine with the
             second dose received at least 5 months before Visit 1.

          -  Abled to attend all scheduled visits and to complied with all study procedures.

        Exclusion Criteria:

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the preceding 6 months; or long-term systemic corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks within the 3 months
             preceding planned inclusion).

          -  Known systemic hypersensitivity to any of the study intervention components, or
             history of a life-threatening reaction to the study interventions used in the study or
             to a product containing any of the same substances.

          -  Previous dermal filler injection (either lips or face fillers).

          -  Thrombocytopenia, contraindicated IM injection.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicated IM vaccination.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with study conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of study intervention administration or febrile illness (temperature >=
             100.4°Fahrenheit [F] [38.0° Celsius {C}]). A prospective participant should not be
             included in the study until the condition had resolved or the febrile event had
             subsided.

          -  History of serious adverse reaction to any influenza or COVID-19 vaccines.

          -  Personal history of Guillain-Barré syndrome (GBS).

          -  Personal history of clinically significant developmental delay (at the discretion of
             the Investigator), neurologic disorder, or seizure disorder.

          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

          -  Any condition that in the opinion of the Investigator posed a health risk to the
             participant if enrolled or could interfere with the evaluation of the vaccine.

          -  Receipt of any vaccine in the 4 weeks preceding the study intervention(s)
             administration or planned receipt of any vaccine in the period between Visit 01 and 4
             weeks following the study intervention(s) administration. Note: Vaccination of Group 3
             participants with Fluzone High-Dose Quadrivalent vaccine at the end of the study was
             not considered by the Sponsor as meeting this exclusion criterion.

          -  Receipt of blood-derived immune globulins, blood, or blood-derived products in the
             past 3 months.

          -  Participation at the time of study enrollment (or in the 30 days preceding the first
             study vaccination) or planned participation during the present study period in another
             clinical study investigating vaccine, drug, medical device, or medical procedure.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Identified as an Investigator or employee of the Investigator or study center with
             direct involvement in the proposed study, or identified as an immediate family member
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with
             direct involvement in the proposed study.

          -  The above information was not intended to contain all considerations relevant to a
             participant's potential participation in a clinical trial.