A Study of Influenza Virus Vaccines in Children and Adults

Exclusion Criteria

• •For all subjects:
• •History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
• •History of serious adverse reaction to any influenza vaccine.
• •Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study.
• •Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.
• •Participation in any other interventional drug or vaccine trial during participation in this study.
• •Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• •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.
• •Prior personal history of Guillain-Barré syndrome.
• •For subjects \> 6 months to \< 5 years of age:
• •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.
• •Known HIV-positive mother.
• •For subjects 18 years of age and older:
• •Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
• •Diabetes mellitus requiring pharmacological control.
• •Person deprived of freedom by an administrative or court order (having legal or medical guardian).
• •For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
• •Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
• •* An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
• •* Clinically significant findings in vital signs or review of systems (Investigator judgment).
• •* Received any vaccinations within the preceding 14 days.
• •* Participation in any other interventional clinical trial within 30 days prior to enrollment.
• •* Receipt of blood or blood products within the three months preceding enrollment in the study.