EUCTR2011-003188-31-IT
Active, not recruiting
Not Applicable
A Phase IV, open label study to evaluate the immune response against homogenous and heterogenous circulating strains in elderly subjects after vaccination with Inflexal V - CroSSome Study
CRUCELL SWITZERLAND AG0 sitesJanuary 23, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CRUCELL SWITZERLAND AG
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 50
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 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.
Outcomes
Primary Outcomes
Not specified
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