A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
Condition: Influenza Vaccines
MeSH terms: Influenza, Human
Intervention: Fluviral
Intervention description: One dose, Intramuscular injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1000.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza

Summary:

      Vaccination is currently the most effective means of controlling influenza and preventing its
      complications and mortality in persons at risk.

      Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a
      recommendation on the influenza A and B strains that should be used for the production of
      vaccine for the coming influenza season. For the strains which do not change from the
      previous year, the vaccine can be formulated from the old mono bulk from the previous year.

      Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under
      the current Canadian and US licenses. This study is conducted to evaluate safety and
      immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new
      bulk material. This protocol posting has been updated in order to comply with the FDA
      Amendment Act, Sept 2007.
    

Eligibility criteria:

        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.