Study on the evaluation of the short-term and long-term response to the anti-flu vaccination Inflexal V in elderly patients

• Conditions: Healthy female and male elderly subjects where influenza vaccination is suggested; MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Health Care [N] - Environment and Public Health [N06]

• Registration Number: EUCTR2011-003188-31-IT
• Lead Sponsor: CRUCELL SWITZERLAND AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-23
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified