Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Cell-Derived Trivalent Subunit Influenza Vaccine Lot 1 (cTIV); Cell-Derived Trivalent Subunit Influenza Vaccine Lot 2 (cTIV); Cell-Derived Trivalent Subunit Influenza Vaccine Lot 3 (cTIV); Egg-Derived Trivalent Subunit Influenza Vaccine (TIV)
Intervention description: One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1; One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2; One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3; One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1200.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Flu; Cell-Derived; Egg-Derived; Healthy Adults; Safety; Immunogenicity; Vaccination

Summary:

      The present study aims to evaluate safety, tolerability and immunogenicity of three lots of
      Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a
      conventional egg-derived control vaccine licensed in Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to <61 years of age

          2. mentally competent to understand the nature, the scope and the consequences of the
             study

          3. able and willing to give written informed consent prior to study entry

          4. in good health as determined by:

               1. medical history,

               2. physical examination,

               3. clinical judgment of the Investigator.

        Exclusion Criteria:

          1. unwilling or unable to give written informed consent to participate in the study

          2. participation in another clinical trial of an investigational agent within 90 days
             prior to Visit 1 and throughout the entire study

          3. currently experiencing an acute infectious disease

          4. any serious disease, such as, for example:

               1. cancer,

               2. autoimmune disease (including rheumatoid arthritis),

               3. advanced arteriosclerotic disease or complicated diabetes mellitus,

               4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,

               5. acute or progressive hepatic disease,

               6. acute or progressive renal disease,

               7. congestive heart failure

          5. surgery planned during the study period

          6. bleeding diathesis

          7. history of hypersensitivity to any component of the study medication or chemically
             related substances

          8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the
             vaccine component

          9. known or suspected impairment/alteration of immune function, for example resulting
             from:

               1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
                  chemotherapy),

               2. receipt of immunostimulants,

               3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
                  derivates within 3 months prior to Visit 1 or planned during the full length of
                  the study,

               4. high risk for developing an immunocompromising disease

         10. history of drug or alcohol abuse

         11. laboratory-confirmed influenza disease within 6 months prior to Visit 1

         12. receipt of influenza vaccine within 6 months prior to Visit 1

         13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination
             within 3 weeks following study vaccination

         14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral
             therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or
             experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to
             Visit 1

         15. if female, pregnant or breastfeeding

         16. if female, refusal to use a reliable contraceptive method during the three weeks
             following vaccination

         17. planned relocation abroad during the study period

         18. any condition that, in the opinion of the Investigator, might interfere with the
             evaluation of the study objectives.