Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent Influenza Virus Vaccine

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 2013-2014 influenza vaccine
• •Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular (IM) vaccination, at the discretion of the Investigator
• •Thrombocytopenia, which may be a contraindication for IM 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 (HIV), 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