Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Fluzone Quadrivalent vaccine, 2018-2019 formulation; Flublok Quadrivalent vaccine, 2018-2019 formulation; Fluzone High-Dose vaccine, 2018-2019 formulation
Intervention description: Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; 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: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was partially randomized. Participants were assigned a vaccine group based on age. Participants in Groups 1, 2, and 5 were not randomly assigned, while participants in Groups 3 and 4 were randomly assigned.
Masking: None (Open Label)
Enrollment: 240.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study were:

        -  To describe the immunogenicity of the 2018-2019 formulation of Fluzone® Quadrivalent
           vaccine in children 6 to less than (<) 36 months of age and 3 to <9 years of age, and in
           adults 18 to <65 years of age; the immunogenicity of the 2018-2019 formulation of
           Flublok® Quadrivalent vaccine in adults 18 to <65 years of age; and the immunogenicity
           of the 2018-2019 formulation of Fluzone High-Dose vaccine in adults greater than or
           equal to (>=) 65 years of age.

        -  To describe the safety of the 2018-2019 formulation of Fluzone Quadrivalent vaccine in
           children 6 to <36 months of age and 3 to <9 years of age, and in adults 18 to <65 years
           of age; the safety of the 2018-2019 formulation of Flublok Quadrivalent vaccine in
           adults 18 to <65 years of age; and the safety of the 2018-2019 formulation of Fluzone
           High-Dose vaccine in adults >=65 years of age.
    

Eligibility criteria:

        Inclusion criteria :

          -  Aged 6 months to <9 years or >=18 years 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 >=2.5 kilograms (kg) (5.5 pounds [lbs.]).

          -  Informed consent form (ICF) had been signed and dated by participants >=18 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.

          -  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:

          -  Participant was pregnant, or lactating, or of childbearing potential and not using an
             effective method of contraception or abstinence from at least 4 weeks prior to
             vaccination and until at least 4 weeks after vaccination. To be considered of
             non-childbearing potential, a female must be pre-menarche, or post-menopausal for at
             least 1 year, or surgically sterile.

          -  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 who received 1 dose of
             influenza vaccine or Visit 3 for participants who received 2 doses of influenza
             vaccine.

          -  Previous vaccination against influenza (in the 2018-2019 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 degree Celsius]). A prospective participant was 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 (participants >=18 years of age) 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
             (all participants).

          -  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.