Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Cell culture-derived trivalent subunit influenza vaccine (cTIV); Egg-derived trivalent subunit influenza vaccine (TIV)
Intervention description: One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle; One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2654.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; immunogenicity; non-inferiority; MDCK; cell culture-derived; subunit influenza vaccine; influenza prevention

Summary:

      The present study aims to evaluate the safety and immunogenicity of the new influenza subunit
      vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 60 years of age (first age group) OR over 60 years of age (second age group)

          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. residence in the study area

          6. in good health as determined by:

               1. medical history,

               2. physical examination,

               3. clinical judgment of the investigator.

        Exclusion Criteria:

          1. unable or unwilling to give written informed consent to participate in the study

          2. suffering from an acute infectious disease

          3. any serious disease such as:

               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 within the past 6 months

          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
             planned vaccination within 3 weeks following the study vaccination

         12. any acute respiratory disease or infections requiring systemic antibiotic or antiviral
             therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or
             experienced fever ≥ 38°C within the past 3 days

         13. pregnant women or women who refused to use a reliable contraceptive method throughout
             the study (180 days)

         14. any condition which, in the opinion of the investigator, might have interfered with
             the evaluation of the study objectives.