Safety and Immunogenicity of FluLaval™ TR and Fluarix® (Influenza Vaccines) in Young and Older Adults

Inclusion Criteria:

• Male or female adults (≥18 yrs)
• Stable health status
• Provide informed consent
• Access to direct phone service (NOT a pay phone or a common-use phone service)
• Eligible females must have a negative pregnancy test

Exclusion Criteria:

• Febrile illness (>38.0°C oral temperature)
• High blood pressure (≥140/90 mmHg)
• Significant acute or chronic
• Uncontrolled medical or psychiatric illness within 1 month prior to vaccination
• Immunosuppressive condition (confirmed or suspected)
• Renal impairment
• Hepatic dysfunction
• Complicated insulin-dependent diabetes mellitus
• Unstable cardiopulmonary disease
• Blood dyscrasias
• Cytotoxic, immunosuppressive drug, or glucocorticoids use within 1 month of vaccination (nasal glucocorticoids allowed)
• History of demyelinating disease
• Active neurological disorder
• Significant alcohol or drug abuse
• Significant coagulation disorder (prophylactic antiplatelet medications allowed)
• Influenza vaccine administrated within 6 months prior to study vaccination
• Administration of any other vaccine from 30 days prior to the end of the study
• Use of non-registered drug within 30 days prior to study vaccination
• Receipt of immunoglobulins and/or any blood products within 3 months of study vaccination
• History or suspected allergy to previous influenza vaccine, or to any constituent of FluLaval™ TR and Fluarix®, or reaction to eggs consumption
• Pregnant or nursing female subjects
• Female subjects not protected by an acceptable contraception method (except if surgically sterile or post-menopausal)