Safety and Immunogenicity of the 2015-2016 Formulation of Fluzone® Quadrivalent (Influenza Vaccine) Among Healthy Children

Study participants will be assigned to the appropriate age group (6 months to < 36 months of
age or 3 years to < 9 years of age) based on the subject's age at the time of enrollment.
Participants aged 6 months to < 36 months will receive a 0.25 mL dose of Fluzone
Quadrivalent vaccine and those aged 3 years to < 9 years will receive a 0.5 mL dose of
Fluzone Quadrivalent vaccine. Participants, for whom 2 doses of influenza vaccine are
recommended per ACIP guidance, will receive a second dose of Fluzone Quadrivalent vaccine
during Visit 2 (28 days after Visit 1).

Solicited adverse event (AE) information will be collected for 7 days after each
vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2 or to
Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will
be collected from Visit 1 to Visit 2 or Visit 3, as appropriate.

Immunogenicity will be evaluated in all subjects prior to vaccination on Day 0 (Visit 1) and
at Day 28 after the final vaccination using the hemagglutination inhibition (HAI) technique.
For each influenza vaccine strain, pre- and post-vaccination geometric mean titers (GMTs)
will be calculated.

Inclusion Criteria:

- Subject is 6 months to < 9 years of age on the day of first study vaccination (study
product administration)

- Subject and parent/guardian are willing and able to attend scheduled visits and to
comply with the study procedures during the entire duration of the study

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

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

Exclusion Criteria:

- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine
components, or a history of a life-threatening reaction to Fluzone Quadrivalent
vaccine or to a vaccine containing any of the same substances (the complete list of
vaccine components is included in the Prescribing Information)

- History of serious adverse reaction to any influenza vaccine

- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to
receive another vaccine before Visit 2 for subjects receiving 1 dose of influenza
vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine

- Participation in another interventional clinical trial investigating a vaccine, drug,
medical device, or medical procedure in the 30 days preceding the first study
vaccination or during the course of the study unless no intervention for the other
study occurred within the 30 days prior to the first study vaccination and none are
planned before the subject would complete safety surveillance for the present study

- Prior vaccination with any formulation of 2015-2016 influenza vaccine

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
which may be a contraindication for intramuscular vaccination, at the discretion of
the Investigator

- Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at
the discretion of the Investigator

- 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 Guillain-Barré syndrome

- 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)

- Personal history of clinically significant developmental delay (at the discretion of
the Investigator), neurologic disorder, or seizure disorder

- Chronic illness that, in the opinion of the Investigator, is at a stage where it
might interfere with trial conduct or completion

- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.

- Moderate or severe acute illness/infection (according to Investigator judgment) on
the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective
subject should not be included in the study until the condition has resolved or the
febrile event has subsided

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

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