Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Cell culture derived influenza vaccine; egg-derived influenza subunit vaccine
Intervention description: as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm; as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 2235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; adult/elderly; flu cell culture; vaccine

Summary:

      The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset)
      following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells
      or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine
      one year before (2004) in the study V58P4.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to < 61 years of age (first age group) OR 61 years of age and older (second age
             group) at enrolment in V58P4

          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. Available for all the visits scheduled in the study

          5. in good health as determined by:

               1. Medical history related to the previous six months,

               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. Currently experiencing an acute infectious disease

          3. Any serious disease such as, for example:

               1. Cancer (except for benign or localized skin cancer and non metastatic prostate
                  cancer not currently treated with chemotherapy)

               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

          4. Surgery planned during the study period

          5. Bleeding diathesis

          6. History of hypersensitivity to any component of the study medication or chemically
             related substances, such as allergy to eggs or egg products

          7. Known or suspected impairment/alteration of immune function resulting from:

               1. Receipt of immunosuppressive therapy (any cortical steroid or cancer
                  chemotherapy)

               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. High risk for developing an immunocompromising disease

          8. History of drug or alcohol abuse

          9. Laboratory confirmed influenza disease in the past 6 months

         10. Received influenza vaccine within the past 6 months

         11. Received another vaccine or any investigational agent within the past 60 days, or
             expect to receive another vaccine within 3 weeks following the study vaccination

         12. Participation in another clinical trial within 90 days prior to enrollment and
             throughout the full length of the study

         13. Any acute respiratory disease or infections requiring systemic antibiotic or antiviral
             therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or
             experienced fever _ 38°C within the past 5 days

         14. Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive
             method during the first three weeks after vaccination

         15. Any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives.