Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 Months of Age

This is an observational and descriptive study that will provide preliminary comparative
information about the safety and immunogenicity of Fluzone® vaccine among children aged 6 to
12 weeks (the investigational group, also referred to as the 2-month-old group) versus
children aged 24 to 36 weeks (the control group, also referred to as the 6-month-old group).
The study is not designed to achieve any preset statistical power, and no hypotheses will be
tested.

Inclusion Criteria :

- Aged 42 to 84 days (6 to 12 weeks) or 24 to 36 weeks on the day of inclusion.

- Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg.

- Considered to be in good health on the basis of reported medical history and
history-directed physical examination.

- Available for the duration of the study.

- Parent/guardian willing and able to provide informed consent.

- Parent/guardian able to attend all scheduled visits and comply with all trial
procedures.

- Willingness to permit venipuncture or heel stick for purposes of collecting a blood
sample.

Exclusion Criteria :

- Reported allergy to egg proteins, chicken proteins or any other constituent of the
vaccine.

- Previous history of influenza vaccination or documented history of influenza
infection.

- Receipt of any vaccine in the 7 days prior to enrollment.

- An acute illness with fever (rectal temperature ≥ 38.0 °C [or ≥ 100.4 °F]) in the 72
hours preceding enrollment in the trial (defer enrollment).

- Known bleeding disorder.

- Participation in any other clinical trial within 30 days prior to enrollment, or
planned participation in another clinical trial prior to termination of the subject's
participation in this study.

- Known or suspected impairment of immunologic function or receipt of immunosuppressive
therapy or immunoglobulin since birth.

- Personal or immediate family history of congenital immune deficiency.

- Developmental delay, neurologic disorder, or seizure disorder.

- Chronic medical, congenital or developmental disorder that could interfere with trial
conduct or completion.

- Known HIV-positive or HBsAg-positive mother.

- Known HIV, hepatitis B (HBsAg), or hepatitis C infection.

- Blood or blood-derived products received in the past 2 months.

- Prior history of Guillain-Barré syndrome.

- Any condition which, in the opinion of the investigator, would pose a health risk to
the subject or interfere with the evaluation of the vaccine.