Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age

Study duration per participant will be approximately 180 days for participants receiving one
dose of vaccine and 208 days for participants receiving two doses of vaccine

Inclusion criteria :

- Aged 6 months to 17 years on the day of inclusion

- Assent form has been signed and dated by the subject (7 to 17 years of age) and
informed consent form has been signed and dated by the parent(s) or guardian(s) and by
an independent witness, if required by local regulations

- Subject / and subject and parent / guardian are able to attend all scheduled visits
and to comply with all study procedures

- For subjects aged < 24 months: Born at full term of pregnancy (≥ 37 weeks) and/or with
a birth weight ≥ 2.5 kg

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 until at least 4 weeks after vaccination. To be considered of
non-childbearing potential, a female must be pre-menarche

- Participation at the time of study enrollment (or in the 4 weeks 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 3 for subjects receiving 1 dose of
influenza vaccine or Visit 5 for subjects receiving 2 doses of influenza vaccine

- For previously influenza vaccinated subjects: Previous vaccination against influenza
in the preceding 6 months with either the study vaccine or another vaccine

- For previously influenza unvaccinated subjects: Any influenza vaccination (from birth
to the day of inclusion) with either the study vaccine or another influenza vaccine

- For previously influenza unvaccinated subjects: Any previous laboratory confirmed
influenza infection (from birth to the day of inclusion)

- 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 vaccines used in the study or to a vaccine containing
any of the same substances

- Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on
Investigator's judgement

- 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 vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A
prospective subject should not be included in the study until the condition has
resolved or the febrile event has subsided

- Identified as an immediate family member (ie, spouse, natural or adopted child,
grandchild, nephew, or niece) of the Investigator or employee with direct involvement
in the proposed study

- Personal history of GBS

- 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 development delay (at the discretion of the
Investigator), neurologic disorder, or seizure disorder

- Known seropositivity for 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.