A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of AGRIPPAL S1 Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2007-2008, when Administered to Non-Elderly Adult and Elderly Subjects - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Adult volunteers who are: 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: (i)medical history; (ii)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

Exclusion Criteria

1. subjects who have any serious disease such as: · cancer (leukemia, lymphomas, neoplasm) except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy; · autoimmune disease (including rheumatoid arthritis); · advanced arteriosclerotic disease or insulin dependent diabetes mellitus; · chronic obstructive pulmonary disease (COPD) that requires oxygen therapy; · acute or progressive hepatic disease; · acute or progressive renal disease; · congestive heart failure; 2. who are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine; 3. who have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine; 4. who 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 cortical steroid 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; 5. who have a known or suspected history of drug or alcohol abuse; 6. who have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject; 7. 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); 8. who, within the past 12 months, have: · received more than one injection of influenza vaccine; 9. who, within the past 6 months, have: · had laboratory confirmed influenza disease; · received influenza vaccine; 10. who, within the past 4 weeks have received: · another vaccine; · any investigational agent; 11. who, within the past 7 days, have experienced: · any acute disease; · infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable); 12. who have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days; 13. who, within the past 3 days have experienced: · fever (i.e., axillary temperature ≥ 38°C); 14. who are taking part in another clinical study; 15. who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective. 16. Women who are breast feeding.

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