A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.

This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.

Inclusion Criteria:

• Healthy males and females aged ≥ 18 to < 65 years at the time of vaccination
• Non pregnant/ non lactating females

Exclusion Criteria:

• Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
• Vaccination against influenza in the previous 6 months
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
• Known history of Guillain-Barré Syndrome;
• Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
• History of neurological disorders or seizures
• Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
• Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
• Administration of immunoglobulins and/or any blood products;
• Participation in a clinical trial or use of an investigational compound;
• Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
• Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.