A Phase II Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface, Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine (Fluad), Formulation 2011/2012, when Administered to elderly subjects. - V70_32S

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Males and females volunteers of 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry. 2. Individuals able to comply with all the study requirements. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject`s ability to participate in the study. Individuals with any serious chronic or acute disease (in the judgment of the investigator), including but not limited to: Medically significant Cancer, prostate cancer that has been clinically stable for more than 2 years without treatment);Medically significant advanced congestive heart failure (ie. NYHA class III and IV); (COPD); Autoimmune disease (including rheumatoid arthritis, except for Hashimoto`s thyroiditis that has been clinically stable for = 5 years); Diabetes mellitus type I; Poorly controlled diabetes mellitus type II;Advanced arteriosclerotic disease;History of underlying medical condition such as major congenital abnormalities requiring surgery, chronic treatment, or associated with developmental delay (e.g., Down’s syndrome); Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological (es. Guillain–Barre` syndrome) or psychiatric disorder; Severe asthma. Individuals with history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to eggs or eggs product as well as ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate; with known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from: receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; receipt of immunostimulants; receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;suspected or known HIV infection or HIV-related disease;with known or suspected history of drug or alcohol abuse.Individuals with a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject; who are not able to comprehend and to follow all required study procedures for the whole period of the study; with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due t participation in the study. Individuals Within the past 6 months, they have: had any seasonal or pandemic laboratory confirmed influenza disease; received any seasonal or pandemic influenza vaccine.Individuals with any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.Individuals that have experienced fever (i.e., axillary temperature = 38?C) within the last 3 days of intended study vaccination.Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study, participating in any clinical trial with another investigational product 4 weeks prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.Individuals who received any other vaccines within 4 weeks prior to enrollment in this st

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method