Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines, 2016-2017 Formulations

All participants received a 0.5-mL intramuscular dose of their assigned vaccine at Visit 1.
For participants 3 to < 9 years of age for whom 2 doses of influenza vaccine were recommended
per Advisory Committee on Immunization Practices (ACIP) guidance, a second dose of Fluzone
Quadrivalent vaccine (of the same volume) was administered during Visit 2.

Solicited adverse reaction (AR) information was collected for 7 days after vaccination.
Unsolicited non-serious adverse event (AE) and serious adverse event (SAE) information was
collected from Visit 1 to Visit 2 or from Visit 1 to Visit 3 for those participants receiving
2 doses of study vaccine.

Immunogenicity was evaluated in all participants prior to vaccination on Day 0 (Visit 1) and
after the final vaccination on Day 28 for 3 to < 9 year olds and Day 21 days for adults 18
years and older.

Inclusion Criteria:

- Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination
(study product administration) .

- Informed consent form 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
informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for
participants 3 to <9 years of age.

- Participant and parent/guardian (of participants 3 to <9 years of age) were able to
attend all scheduled visits and to comply with all trial 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
trial vaccination) or planned participation during the present trial period in another
clinical trial investigating a vaccine, drug, medical device, or medical procedure.

- Receipt of any vaccine in the 30 days preceding the first trial 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 2016-2017 influenza season) with either
the trial vaccine or another vaccine.

- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.

- 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 past 3 months).

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine used in the trial 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 trial 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 [38.0°C]). A
prospective participant 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 (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.