Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008
Condition: Seasonal Influenza Vaccine
MeSH terms: Influenza, Human
Intervention: cTIV
Intervention description: One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine

Summary:

      Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell
      culture, using the strain composition 2007/2008, when administered to adult and elderly
      subjects
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects eligible for enrollment into this study are male and female adults who were:

          1. ≥ 18 years of age, mentally competent, willing and able to give informed consent prior
             to study entry

          2. available for all the visits scheduled in the study and able to comply with all study
             requirements

          3. in good health as determined by:

               -  medical history

               -  physical examination

               -  clinical judgment of the investigator Written informed consent had to be obtained
                  from all the subjects before enrollment in the study after the nature of the
                  study had been explained.

        Exclusion Criteria:

        Subjects were not to be enrolled into the study if at least one of the following criteria
        was fulfilled:

          1. Any serious chronic or acute disease such as:

               1. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin
                  cancer and non-metastatic prostate cancer not presently treated with chemotherapy

               2. Congestive heart failure

               3. Advanced arteriosclerotic disease

               4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or
                  acute exacerbation of a COPD within the last 14 days.

               5. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive
                  therapy (see below)

               6. Insulin dependent diabetes mellitus

               7. Acute or progressive hepatic disease

               8. Acute or progressive renal disease

               9. Severe neurological or psychiatric disorder

          2. History of any anaphylactic reaction and/or serious allergic reaction following a
             vaccination, a proven hypersensitivity to any component of the study vaccine or
             chemically related substances

          3. Known or suspected (or have a high risk of developing) impairment/alteration of immune
             function (excluding that normally associated with advanced age) resulting for example
             from:

               1. Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive
                  drugs, any parenteral or oral corticosteroid (substitution dose in case of
                  absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy)
                  within the last 2 months and for the full length of the study,

               2. Receipt of immunostimulants,

               3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivatives within the past 3 months and for the full length of the study,

               4. Suspected or known HIV infection or HIV-related disease.

          4. Known or suspected history of drug or alcohol abuse

          5. Bleeding diathesis or receive anticoagulants of the coumarin type

          6. Women who are pregnant or woman of childbearing potential unwilling to practice
             acceptable contraception for the duration of the study (21 days)

          7. Influenza immunization or laboratory confirmed influenza within the last 6 months and
             more than one influenza immunization within the past 12 months

          8. Immunization with any other vaccine and/or any investigational vaccine four weeks
             prior to study start

          9. Any significant acute or chronic infections requiring systemic antibiotic treatment or
             antiviral therapy within the last 7 days

         10. Fever (i.e. body temperature ≥ 38.0°C) within the past 3 days prior to study entry

         11. Simultaneous participation in another clinical study

         12. Any condition, which, in the opinion of the investigator, might prevent the subject
             from participation or interfere with the evaluation of the study objectives.