A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUad Surface Antigen, Inactivated, Adjuvanted with MF59C.1 Influenza Vaccine, Formulation 2008-2009, when Administered to Elderly Subjects - ND
- Conditions
- Treatment against the flu 2008-2009MedDRA version: 9.1Level: LLTClassification code 10022000Term: Influenza
- Registration Number
- EUCTR2008-001047-19-IT
- Lead Sponsor
- OVARTIS VACCINES AND DIAGNOSTICS S.R.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry; 2. able to comply with all the study requirements; 3. in general good health as determined by: ▫ medical history; ▫ physical examination; ▫ 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) yes
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
1. They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: a. Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis); e. Acute or progressive hepatic disease; f. Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma. 2. They have 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 ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate); 3. They have a 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: - recipt 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; - recipt of immunostimulants; - recipt 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; 4. They have a known or suspected history of drug or alcohol abuse; 5. They have a bleeding diathesis or condition associated with prolonged bleeding time that in the investigator?s opinion would interfere with the safety of the subject; 6. Within the past 12 months, they have: - received more than one injection of influenza vaccine; 7. Within the past 6 months, they have: - had laboratory confirmed influenza disease; - received influenza vaccine; 8. Within the past 4 weeks they have received: - another vaccine; - any investigational agent; 9. They have any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 10. They have experienced an acute exacerbation of a COPD within the past 14 days; 11. They have experienced fever (i.e., axillary temperature ≥ 38C) within the last 3 days; 12. They are taking part in another clinical study; 13. They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives; 14. They have severely obese with Body Mass Index (BMI) > 35
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