A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

This multicenter, randomized, double-blinded study was conducted during the 2014-2015
Northern Hemisphere influenza immunization season to evaluate the non-inferior immune
response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy
male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day
on-study period with a six month safety follow-up.

Inclusion Criteria:

- Males or non-pregnant females aged ≥ 18 years at the time of vaccination.

- Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically
sterile) must be abstinent or be willing to use a medically accepted contraceptive
regimen for the duration of the On-study period. Females of child-bearing potential
must return a negative urine pregnancy test result prior to vaccination with the
vaccine.

Exclusion Criteria:

- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,
chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.

- Vaccination against influenza in the previous 6 months.

- Known history of Guillain-Barré Syndrome or other demyelinating disease.

- Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).

- A clinically significant medical condition.

- Pregnant or lactating females.