Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects
Condition: Influenza; Orthomyxoviruses; Myxovirus Infection
MeSH terms: Influenza, Human
Intervention: Influenza virus vaccine - cell based (2007-2008 Formulation); Influenza virus vaccine - cell-based (2007-2008 Formulation); Influenza virus vaccine (2007-2008 Formulation)
Intervention description: 0.5 mL, Intramuscular; 1.0 mL, Intramuscular; 0.5 mL, Intramuscular
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 729.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Orthomyxoviruses; Split-virion inactivated influenza vaccine; cell-based vaccine; Adults

Summary:

      Primary Objective:

      To describe the immune response to a single administration of 2 formulations of the
      investigational cell-based influenza vaccines in healthy adult subjects.

      Secondary Objective:

      To describe the safety following a single administration of 2 formulations of the
      investigational cell-based influenza vaccines in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Healthy male or female subject, aged ≥ 18 to < 50 years on the day of inclusion

          -  Informed consent form signed

          -  Able to attend all scheduled visits and to comply with all trial procedures

          -  For a woman of childbearing potential: a negative urine pregnancy test and documented
             use of an effective method of contraception or abstinence for at least four weeks pre
             vaccination and up until three weeks post-vaccination

        Exclusion Criteria :

          -  Subject currently breast-feeding.

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Prior participation in the Phase I trial of FLU INTERPAN (PER.C6) vaccine (study
             GCE01).

          -  Congenital or history of acquired immunodeficiency, or immunosuppressive therapy such
             as anti-cancer chemotherapy or radiation therapy within the preceding 6 months.

          -  Systemic corticosteroid therapy as except the use of topical or inhalant
             corticosteroids

          -  Systemic hypersensitivity to egg proteins, chicken proteins, or to any of the vaccine
             components, or history of a life-threatening reaction to the trial vaccine or a
             vaccine containing the same substances.

          -  Chronic illness at a stage that could interfere with trial conduct or completion
             (chronic illness may include, but is not limited to, cardiac, renal or auto-immune
             disorders, or diabetes).

          -  Receipt of blood or blood-derived products in the 3 months preceding vaccination.

          -  Receipt of any vaccination in the 4 weeks preceding vaccination, or planned receipt of
             any vaccination in the 4 weeks following the trial vaccination.

          -  History of influenza infection (confirmed either clinically, serologically or
             microbiologically) within the 6 months preceding vaccination.

          -  Previous vaccination against influenza (in the 6 months preceding the trial
             vaccination).

          -  Planned receipt of any other 2007-2008 influenza vaccine.

          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.

          -  Subject deprived of freedom by an administrative or court order, or in an emergency
             setting, or hospitalized without his/her consent.

          -  History of Guillain-Barré syndrome

          -  Current abuse of alcohol or drug addiction that may interfere with the subject's
             ability to comply with trial procedures

          -  Any other condition which in the opinion of the investigator would pose a health risk
             to the participant or interfere with the evaluation of the vaccine.