Immunogenicity and Safety Study to Assess Influenza Vaccine Formulated With Haemagglutinin (HA) Antigen From Two Different Suppliers
- Conditions
- Influenza
- Interventions
- Biological: Virosomal influenza vaccine (AdImmune HA Antigen)Biological: Virosomal influenza vaccine (CSL HA Antigen)
- Registration Number
- NCT01412281
- Lead Sponsor
- Crucell Holland BV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 440
- Healthy female and male adults
- Aged ≥18 years on Day 1
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A - Young adults Virosomal influenza vaccine (AdImmune HA Antigen) 1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 Group B - Young adults Virosomal influenza vaccine (CSL HA Antigen) 1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012 Group C - Elderly Virosomal influenza vaccine (AdImmune HA Antigen) 1 x 0.5 mL i.m. virosomal influenza vaccine (AdImmune HA Antigen) 2011/2012 Group D - Elderly Virosomal influenza vaccine (CSL HA Antigen) 1 x 0.5 mL i.m. virosomal influenza vaccine (CSL HA Antigen) 2011/2012
- Primary Outcome Measures
Name Time Method Geometric Mean Titer 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 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 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 Outcome Measures
Name Time Method 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) Solicited local and systemic AEs, Unsolicited AEs, Tolerability and acceptability
Unsolicited AEs were collected from baseline (Day 1) to 3 weeks after vaccination (Day 22 ± 2 days).
Solicited local and systemic AEs were collected by subjects diary from Day 1 (day of vaccination) to Day 4
Trial Locations
- Locations (1)
Covance Clinical Research Unit AG
🇨🇭Allschwil, Switzerland