Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains
- Conditions
- Influenza
- Interventions
- Biological: Inflexal V
- Registration Number
- NCT01631110
- Lead Sponsor
- Crucell Holland BV
- Brief Summary
The study is to assess whether the influenza vaccine Inflexal V for season 2012/2013 fulfills the EMA requirements for re-registration of influenza vaccines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Healthy female and male adults aged ≥18 on Day 1
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
- 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 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, including oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, HIV seropositivity), cancer
- 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 relative of the investigator
- Subjects who in the view of the investigator will not comply with study procedures and/or visit requirements as per protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elderly subjects aged over 60 years Inflexal V - Adults from 18 to 60 years old inclusive Inflexal V -
- Primary Outcome Measures
Name Time Method Seroconversion 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)
Geometric Mean Titer 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 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)
- 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
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