Safety and Immunogenicity of Fluzone® Quadrivalent, Flublok® Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines, 2018-2019 Formulations

Study duration per participant will be approximately 28 days for participants receiving one
dose of vaccine and 56 days for participants receiving two doses of vaccine.

Inclusion criteria :

- Aged 6 months to < 9 years or ≥ 18 years on the day of first study vaccination (study
product administration).

- For subjects 6 to < 12 months of age, born at full term of pregnancy (≥ 37 weeks) and
with a birth weight ≥ 2.5 kg (5.5 lbs).

- Informed consent form (ICF) has been signed and dated by subjects ≥ 18 years of age

- Assent form has been signed and dated by subjects 7 to < 9 years of age, and ICF has
been signed and dated by parent(s) or guardian(s) for subjects 6 months to < 9 years
of age.

- Subject and parent/guardian (of subjects 6 months to < 9 years of age) are able to
attend all scheduled visits and to comply with all study procedures

Exclusion criteria:

- Subject is 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 subjects receiving 1 dose of
influenza vaccine or Visit 3 for subjects receiving 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 may 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, is 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 F [38.0oC]). A
prospective subject should not be included in the study until the condition has
resolved or the febrile event has subsided.

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study (subjects ≥ 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 subjects).

- 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
subject 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 is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.