Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Cell culture-derived influenza vaccine; Egg-derived influenza virus vaccine; Placebo
Intervention description: One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.; One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.; One dose (0.5 mL) of phosphate buffered solution.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 11404.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Flu; Cell Culture-Derived; Egg-Derived; Healthy Adults; Efficacy; Safety; Immunogenicity; Trivalent; Inactivated; Influenza-Like Illness; Vaccination

Summary:

      The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of
      both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in
      healthy adults 18 to 49 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. subjects 18 to 49 years of age;

          2. in good health as determined by medical history and physical examination;

          3. able and willing to provide written informed consent prior to any study procedure;

          4. able to comply with all study procedures, including availability and willingness to be
             actively followed throughout the ensuing influenza season with weekly telephone calls
             and to comply with the need for prompt collection of nasal and throat specimens in the
             event of influenza symptoms.

        Exclusion Criteria:

          1. history of anaphylaxis or serious reaction after administration of any vaccine, or
             hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein,
             neomycin, kanamycin, or any other vaccine component, chemically related substance, or
             component of the potential packaging materials;

          2. any health condition for which the inactivated vaccine is recommended by the Advisory
             Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary
             or cardiovascular systems (including asthma), chronic metabolic diseases (including
             diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including
             HIV infection) or on-going immunosuppressive therapy;

          3. employment in professions prone to influenza transmission to or from high-risk
             populations (this exclusion specifically includes nurses, physicians, all other
             healthcare workers with direct patient contact; and police, fire, and rescue
             personnel); or living in the same household as an immunocompromised person;

          4. history of Guillain-Barré syndrome;

          5. bleeding diathesis;

          6. receipt of another investigational agent within 90 days prior to enrollment in the
             study or before completion of the safety follow-up period in another study, whichever
             is longer, and unwilling to refuse participation in another clinical study through the
             end of the study;

          7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for
             live vaccines) prior to Visit 1;

          8. laboratory-confirmed influenza disease within 6 months prior to Visit 1;

          9. receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive
             influenza vaccine outside of this study;

         10. experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days
             prior to study vaccination;

         11. pregnant or breast-feeding female;

         12. if female of childbearing potential and sexually active, has not used any of the birth
             control methods detailed in the section entitled "Females of Childbearing Potential"
             for at least 2 months prior to study entry;

         13. if female of childbearing potential and sexually active, refusal to use a reliable
             contraceptive method as detailed in the section entitled "Females of Childbearing
             Potential" during the first 3 weeks after vaccination;

         14. research staff directly involved with the clinical study or family members or
             household members of research staff. Research staff are individuals with direct or
             indirect contact with study subjects, or study site personnel who have access to any
             study documents containing subject information. This would include receptionists,
             persons scheduling appointments or making screening calls, regulatory specialists,
             laboratory technicians, etc.;

         15. any condition which, in the opinion of the investigator, might interfere with the
             evaluation of the study objectives or with the safety of the study subject.