Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Suppliers
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Inflexal V influenza vaccine (CSL HA Antigen) 2010; Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011
Intervention description: Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus; Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; Virus; Vaccination; Immunisation

Summary:

      The purpose of this study is to assess the humoral immune response and safety of the
      parenteral formulation of the 2010/2011-season virosomal subunit influenza vaccine Inflexal V
      using two different HA antigen suppliers (AdImmune and CSL), in groups of young and elderly
      adults, using the EMA (European Medicines Agency) regulation as a guideline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female and male adults

          -  Aged ≥18 years on Day 1

          -  Written informed consent

        Exclusion Criteria:

          -  Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or
             other acute disease

          -  Acute febrile illness (≥38.0 °C)

          -  Prior vaccination with an influenza vaccine (including the H1N1 pandemic swine flu
             vaccine) in the past 330 days

          -  Known hypersensitivity to any vaccine component

          -  Previous history of a serious adverse reaction to influenza vaccine

          -  History of egg protein allergy or severe atopy

          -  Known blood coagulation disorder

          -  Chronic (longer than 14 days) administration of immunosuppressants or other
             immune-modifying drugs within 6 months before the first dose of the study vaccine,
             incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent
             (inhaled or topical steroids are allowed)

          -  Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)

          -  Investigational medicinal product received in the past 3 months (90 days)

          -  Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months
             (90 days)

          -  Pregnancy or lactation

          -  Participation in another clinical trial

          -  Employee at the investigational site, or spouse and children of the investigator, or
             relative living in the same household as the investigator and/or are dependent on the
             investigator

          -  Suspected non-compliance