Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation; Fluzone High-Dose vaccine, 2019-2020 formulation
Intervention description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
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: 83 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study was to provide sera (collected from participants before
      vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for
      Biologics Evaluation and Research (CBER) for further analysis by the World Health
      Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and
      Drug Administration (FDA) to support formulation recommendations for subsequent influenza
      vaccines.
    

Eligibility criteria:

        Inclusion criteria :

        An individual who fulfilled all of the following criteria were eligible for study
        enrollment:

          -  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 pounds (2.5 kilograms).

          -  Informed consent form (ICF) had been signed and dated by participants >= 65 years of
             age.

          -  Assent form had been signed and dated by participants 7 to < 9 years of age, and ICF
             had been signed and dated by parent(s) or guardian(s) for participants 6 months to < 9
             years of age.

          -  Participant and parent/guardian (of participants 6 months to < 9 years of age) were
             able to attend all scheduled visits and complied with all study procedures.

        Exclusion criteria:

        An individual who fulfilled any of the following criteria were excluded from study
        enrollment:

          -  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.

          -  Receipt of any vaccine in the 30 days preceding the first study vaccination, 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 2019-2020 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.

          -  Thrombocytopenia, which might be a contraindication for intramuscular vaccination, at
             the discretion of the Investigator.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular 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 were 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
             participants 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.