Influenza
Conditions
Keywords
Influenza, Virus, Vaccination, Inflexal V
Brief summary
The study is to assess whether the influenza vaccine Inflexal V for season 2013/2014 fulfills the EMA requirements for re-registration of influenza vaccines.
Interventions
BIOLOGICALInflexal V
Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
Sponsors
Crucell Holland BV
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with seroconversion, seroprotection, and fold increase in geometric mean titer (GMT) | Day 22 +/- 2 days | Immunogenicity variables are analyzed according to the EMA re-licensing criteria; at least one of the criteria has to be fulfilled for each vaccine strain: * Seroconversion rate at Day 22 has to be \>40% of subjects aged ≥18 to ≤60 years and \>30% of subjects aged \>60 years, or * Seroprotection rate at Day 22 has to be \>70% of subjects aged ≥18 to ≤60 years and \>60% of subjects aged \>60 years, or * GMT-fold increase at Day 22 compared to baseline: a \>2.5-fold increase has to be reached in subjects aged ≥18 to ≤60 years and a \>2.0-fold increase has to be reached in subjects aged \>60 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of solicited local adverse events | Days 1 to 4 inclusive |
| Incidence of solicited systemic adverse events | Days 1 to 4 inclusive |
| Incidence of unsolicited adverse events | Days 1 to 22 inclusive |
Countries
Switzerland
Outcome results
None listed