A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers

A Phase IV, Single-centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2009/2010 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged ≥ 18 to < 60 Years) and 'Older Adults' (Aged ≥ 60 Years).

The purpose of the study is to assess the efficacy and safety of CSL's 2009/2010 formulation of the Enzira vaccine.

Inclusion Criteria:

• Males or females aged ≥ 18 years at the time of providing informed consent
• Participants are capable of understanding the purposes and risks of the study and are able to provide written informed consent
• Willing and able to adhere to all protocol requirements
• Able to provide a sample of approximately 17 mL of venous blood on two separate occasions without undue distress/discomfort
• 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 study

Exclusion Criteria:

• Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Enzira® vaccine
• Clinical signs of an active infection and/or an elevated oral temperature (≥ 38.0°C) at study entry
• A clinically significant medical or psychiatric condition
• A confirmed or suspected immunosuppressive condition
• History of seizures
• History of Guillain-Barré Syndrome
• Vaccination with a seasonal influenza virus vaccine or with an experimental influenza virus vaccine in the 6 months preceding study entry
• Currently receiving treatment with radiotherapy or cytotoxic drugs, or have received such treatment within the 6 months preceding administration of Enzira® vaccine
• Currently receiving systemic glucocorticoid therapy (excluding 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 Enzira® vaccine
• Currently participating in another investigational study or recent study participation ending 3 months preceding administration of Enzira® vaccine
• Currently receiving treatment with warfarin or other anticoagulants
• Evidence or history of substance or alcohol abuse within the 12 months before study entry
• Females of child bearing potential who are planning to become pregnant or planning to discontinue contraceptive precautions during the study period
• Females who are pregnant or lactating
• Any issues that, in the opinion of the investigator, would render the subject unsuitable for study participation