A Study to Assess the Immunogenicity and Safety of CSL's 2009 / 2010 Formulation of Enzira® Vaccine in Healthy Volunteers
Condition: Influenza
Intervention: Inactivated Influenza Vaccine (2009 / 2010 formulation)
Intervention description: A single 0.5mL intramuscular injection into the deltoid region of the arm on Day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility criteria:

        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