A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Inclusion Criteria:

• Males or females aged 5 to less than 9 years at the time of first study vaccination.
• The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
• In good health, as determined by medical history and a targeted physical examination (if warranted).

Exclusion Criteria:

• Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
• Clinical signs of significant active infection or an elevated oral temperature at study entry.
• A clinically significant medical or psychiatric condition.
• A history of seizures or febrile convulsions or Guillain-Barré syndrome.
• Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
• Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
• Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
• Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
• Currently receiving treatment with warfarin or other anticoagulants.