Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 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), 2020-2021 formulation; Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
Intervention description: Pharmaceutical form: Suspension for injection in a pre-filled syringe,
Route of administration: Intramuscular (IM); Pharmaceutical form: Suspension for injection in a pre-filled syringe,
Route of administration: 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
Maximum age: 84 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Primary Objective:

      To provide serum samples (collected from participants before vaccination [Blood Sample 1] and
      after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research
      (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease
      Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation
      recommendations for subsequent influenza vaccines. In addition, serum samples from adult
      participants may be further analyzed by the Sponsor to assess breadth of immune response
      induced by the study vaccines.
    

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 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 kilograms [kg]).

          -  Informed consent form (ICF) was signed and dated by participants >=65 years of age.

          -  Assent form was signed and dated by participants 7 to <9 years of age, and ICF was
             signed and dated by parent(s) or guardian(s) for participants 6 months to < 9years of
             age.

          -  Participants and parent/guardian (of participants 6 months to <9 years of age) were
             able to attend all scheduled visits and to comply with all study procedures.

        Exclusion criteria:

        - 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 were considered eligible for enrollment if no intervention for the other
        study occurred within the 30 days prior to the first study vaccination and none are planned
        before the participant would complete safety surveillance for the present study.

          -  Receipt of any vaccine in the 30 days preceding the first study vaccination, or
             planned receipt of any vaccine before Visit 2 for participants received 1 dose of
             influenza vaccine or Visit 3 for participants received 2 doses of influenza vaccine.

          -  Previous vaccination against influenza (in the 2020-2021 influenza season) with either
             study vaccine or another vaccine.

          -  Receipt of immune globulins, blood, or blood-derived products in the 3 months
             preceding planned inclusion.

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
             within the 6 months preceding planned inclusion; 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 vaccine components, or history of a
             life-threatening reaction to study vaccine or to a vaccine containing any of the same
             substances.

        Note: The list of vaccine components was included in the Prescribing Information for each
        study vaccine.

          -  Thrombocytopenia, which might be a contraindication for IM vaccination, at the
             discretion of the Investigator.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating IM vaccination.

          -  Deprived of freedom by an administrative or court order, or in an emergency setting,
             or hospitalized involuntarily.

          -  Current alcohol abuse or drug addiction.

          -  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 planned vaccination or febrile illness (temperature >=100.4 degree [°]
             Fahrenheit [38.0° Celsius]). A prospective participant not included in the study until
             the condition had resolved or the febrile event had subsided.

          -  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) or in-laws of the Investigator or
             employee with direct involvement in the proposed study.

          -  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.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.