Status:
COMPLETED
Re-licensing Study to Assess Inflexal V Formulated With WHO Recommended Influenza Strains (2013-14)
Lead Sponsor:
Crucell Holland BV
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01893177
Start Date
July 1 2013
End Date
August 1 2013
Last Update
August 30 2013
Active Locations (1)
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1
CROSS Research S.A. - Phase I Unit
Arzo, Switzerland, 6864