Status:
COMPLETED
A Study to Assess Immunogenicity Parameters After Vaccination Against Influenza and to Evaluate How These Parameters Change During the Influenza Season
Lead Sponsor:
Crucell Holland BV
Conditions:
Influenza
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
A study to evaluate the humoral immune response 3 weeks after vaccination with Inflexal V according to the CHMP criteria in elderly subjects for the 2011/2012 WHO recommended vaccine strains, to evalu...
Eligibility Criteria
Inclusion
- Healthy female and male adults aged \>60 years on the day of enrollment
- Written informed consent
- Females with confirmed menopause (postmenopausal is defined as 12 months with no menses without an alternative medical cause)
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 for season 2011/2012
- 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/day prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (including leukemia, HIV seropositivity) or 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)
- Participation in another clinical trial
- Employee at the investigational site or relative of the investigator
- Anticipated non-compliance with study procedures
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01457027
Start Date
October 1 2011
End Date
August 1 2012
Last Update
February 20 2013
Active Locations (1)
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1
Dept. of Health Sciences, University of Genoa and Hygiene Unit, "San Martino" University Hospital
Genoa, Italy, 16100