Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Condition: Influenza Immunization; Healthy Volunteers
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation; Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation
Intervention description: Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM); Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This was a phase IV, multi-center, open-label study. The study collected serum samples from
      children 6 months to less than (<) 9 years of age who received Fluzone Quadrivalent vaccine
      and adults greater than or equal to (>=) 65 years of age who received Fluzone High-Dose
      Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection
      process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 6 months to < 9 years or >= 65 years of age on the day of first study vaccination
             (study product administration).

          -  For infants and toddlers, born at full term of pregnancy (>=37 weeks) or born after a
             gestation period of 27 through 36 weeks.

          -  For participants 6 to < 12 months of age, born at full term of pregnancy (>= 37 weeks)
             and with a birth weight >= 5.5 pound (lbs) (2.5 kilogram [kg]).

          -  Informed consent form (ICF) has been signed and dated by participants >= 65 years of
             age.

          -  Assent form has been signed and dated by participants 7 to < 9 years of age, and ICF
             has been signed and dated by parent(s) or another legally acceptable representative
             for participants 6 months to < 9 years of age.

          -  Participants or participant and parent/legally acceptable representative (of
             participants 6 months to < 9 years of age) were able to attend all scheduled visits
             and complied with all study procedures.

        Exclusion Criteria:

          -  Participants are excluded from the study if any of the following criteria apply:

          -  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.

          -  Thrombocytopenia, contraindicating IM injection, at the discretion of the
             Investigator.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating 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 [38.0° Celsius]). A prospective participant should not be included in the
             study until the condition has resolved or the febrile event has subsided.

          -  Alcohol, prescription drug, or substance abuse that, in the opinion of the
             Investigator, might interfere with the study conduct or completion.

          -  History of serious adverse reaction to any influenza vaccine.

          -  Personal history of Guillain-Barré syndrome.

          -  Any condition that in the opinion of the Investigator would pose a health risk to the
             participant if enrolled or could interfere with the evaluation of the vaccine.

          -  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.

          -  Receipt of any vaccine in the 30 days preceding the first study intervention
             administration, or planned receipt of any vaccine before Visit 2 for participants
             receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of
             influenza vaccine.

          -  Previous vaccination against influenza (in the 2021-2022 influenza season) with an
             investigational or marketed vaccine.

          -  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 a vaccine, drug, medical device, or medical procedure.

        Note: Participants might be considered eligible for enrollment if no intervention for the
        other study occurred within the 30 days prior to the first study vaccination and none were
        planned before the participant would complete safety surveillance for the present study.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.