A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, when Administered to Non-elderly Adult and Elderly Subjects - ND
- Conditions
- Prophylaxis against flu virus 2008-2009.MedDRA version: 9.1Level: HLTClassification code 10022005MedDRA version: 9.1Level: PTClassification code 10022000
- Registration Number
- EUCTR2008-001079-31-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
1.18 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) no
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 hypersensivity 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:
-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;
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.Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);
7.Within the past 12 months, they have:
-received more than one injection of influenza vaccine
8.Within the past 6 months, they have:
-had laboratory confirmed influenza disease;
-received influenza vaccine;
9.Within the past 4 weeks they have received:
-another vaccine;
-any investigational agent;
10.They have any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
11.They have experienced an acute exacerbation of a COPD within the past 14 days;
12.They have experienced fever (i.e., axillary temperature≥ 38C) within the last 3 days;
13.They are taking part in another clinical study;
14.They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
15.They are 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