Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects
Condition: Pandemic Influenza Disease
MeSH terms: Influenza, Human
Intervention: Placebo (PL); Trivalent influenza virus vaccine (TIV); Adjuvanted monovalent influenza virus vaccine (aH5N1); Adjuvanted trivalent influenza virus vaccine (aTIV)
Intervention description: One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.; A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.; Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.; Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3647.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: virus; pandemic influenza; vaccine

Summary:

      The present study, phase III, randomized, controlled, observer-blind, multicenter study, will
      evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent
      influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a
      population of healthy adult and elderly subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 18 years of age and older who were mentally competent and who had signed an
             informed consent form after having received a detailed explanation of the study
             protocol;

          -  In good health as determined by:

               1. medical history,

               2. physical examination,

               3. clinical judgment of the Investigator;

          -  Able to understand and comply with all study procedures and to complete study diaries,
             could be contacted, and were available for study visits;

        Exclusion Criteria:

          -  Receipt of another investigational agent within 4 weeks;

          -  Laboratory-confirmed influenza disease within 6 months prior to Visit 1;

          -  Receipt of influenza vaccination for current season 2008/2009;

          -  Experienced any acute disease or infection requiring systemic antibiotic or antiviral
             therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
             within the past 7 days;

          -  Experienced fever (defined as axillary temperature ≥38.0°C) within 7 days prior to
             Visit 1;

          -  Pregnant or breastfeeding;

          -  Females of childbearing potential who were sexually active and had not used or did not
             plan or refused to use an acceptable method of birth control during the active phase
             of the study (at least up to three weeks after last vaccine injection);

          -  Any serious disease, such as: cancer, autoimmune disease (including rheumatoid
             arthritis); diabetes mellitus type I and type II; diabetes relating to genetic
             defects/syndromes, diseases of the exocrine pancreas or infections; advanced
             arteriosclerotic disease; severe chronic obstructive pulmonary disease (COPD), i.e.
             GOLD stages 3 and 4; acute or progressive hepatic disease and renal disease;
             congestive heart failure; Body Mass Index (BMI) ≥35 kg/m2 where BMI reflects obesity
             and not high muscle mass;

          -  History of progressive or severe neurologic disorders, of any neurological symptoms or
             signs, or anaphylactic shock following administration of any study vaccine;

          -  Bleeding diathesis;

          -  Surgery planned during the study period;

          -  Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,
             neomycin or polymyxin or any other component of the study vaccines;

          -  Known or suspected impairment/alteration of immune function, for example, resulting
             from:

               1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer
                  chemotherapy) or other immunosuppressive agents within the past 60 days and for
                  the full length of the study;

               2. receipt of immunostimulants;

               3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma
                  derivates within the past 3 months and for the full length of the study;

               4. suspected or known HIV infection or HIV-related disease;

          -  Receipt of non study vaccines (with the exception of post-exposure vaccination in a
             medical emergency, e.g. hepatitis, rabies, tetanus) within 3 weeks prior to Visit 1 or
             planned vaccination within 3 weeks following the last study vaccination;

          -  History of (or current) drug or alcohol abuse that in the investigator's opinion would
             interfere with safety of the subject or the evaluation of study objectives;

          -  Members of research staff and their relatives;

          -  Any condition, which, in the opinion of the Investigator, might interfere with the
             evaluation of the study objectives.