A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
• Male and female adults, 18 to 60 years.
• Written informed consent obtained from the subject.
• If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.

Exclusion Criteria:

• Acute disease at the time of enrollment.
• Any confirmed or suspected immunosuppressive condition
• Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• A history of any demyelinating disease including Guillain-Barré syndrome.
• Presence of an active neurological disorder.
• Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
• Receipt of an influenza vaccine within 6 months prior to study enrollment.
• Administration of any vaccines within 30 days prior to study enrollment or during the study period.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
• Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
• Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
• A history of severe adverse reaction to a previous influenza vaccination.
• Lactating/nursing female.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.