Randomized, Parallel-group, Double-blind, Single-center Phase III Study to Assess the Immunogenicity and Safety of the 2011/2012-season Influenza Vaccine Formulated With HA Antigen From Two Suppliers, in Elderly and Young Adult Subjects Using the Current EMA Regulations as Guideline
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 440
- Locations
- 2
- Primary Endpoint
- Geometric Mean Titer
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Geometric Mean Titer
Time Frame: 3 weeks after vaccination (Day 22 ± 2 days)
GMT of HI antibodies and fold-increase in GMT (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroprotection
Time Frame: 3 weeks after vaccination (Day 22 ± 2 days)
Seroprotection rate, defined as proportion of subjects with HI antibody titer ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Seroconversion
Time Frame: 3 weeks after vaccination (Day 22 ± 2 days)
Seroconversion rate, defined as proportion of subjects with ≥4-fold increase in HI antibody titer and with a titer of ≥1:40 (The primary endpoints are the immunogenicity parameters for HA assessed via hemagglutinin inhibition method (HI). These parameters were analyzed according to the EMA "Note for guidance on harmonisation of requirements for influenza vaccines," 1997)
Secondary Outcomes
- Number of Participants With Local and Systemic Adverse Events, as a Measure of Safety and Tolerability(Baseline (Day 1) and 3 weeks after vaccination (Day 22 ± 2 days))