Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children

All participants received 1 intramuscular dose of Fluzone Quadrivalent vaccine during Visit
1. For participants, 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 as the first dose) was administered during Visit 2 (28 days after
Visit 1).

Solicited adverse event (AE) information was collected for 7 days after each vaccination,
unsolicited AE information was collected from Visit 1 to Visit 2 or to Visit 3 for
participants receiving 2 doses of study vaccine. Serious adverse event (SAE) information was
collected for 28 days after each vaccination.

Immunogenicity was evaluated in a planned subset of 1600 randomly selected participants prior
to vaccination on Day 0 (Visit 1) and at Day 28 after the final vaccination.

Inclusion Criteria:

- Aged 6 to < 36 months of age on the day of first study vaccination (study product
administration).

- Born at full term of pregnancy (≥37 weeks) and/or with a birth weight ≥2.5 kg. Note:
This inclusion criterion only applies to participants 6 to <12 months of age on the
day of the first study visit.

- Informed consent form has been signed and dated by the parent(s) or guardian(s).

- Participant and parent/guardian are able to attend all scheduled visits and to comply
with all trial procedures.

Exclusion Criteria:

- 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 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.

- 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 degrees Fahrenheit
[38.0 degrees Celsius]). A prospective participant should not be included in the study
until the condition has resolved or the febrile event has subsided.

- Identified as a natural or adopted child of either the Investigator or an employee
with direct involvement in the proposed study.

- History of serious adverse reactions 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.