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 - Agrippal seasonal trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 126

Inclusion Criteria

Subjects eligible for enrollment into this study are male and female 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:
·medical history;
·physical examination;
·clinical judgment of the investigator;

Informed consent must be obtained for all the subjects before enrollment into the study.

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

Individuals are not to be enrolled into the study if:
1. they 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. they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate or any other component of the vaccine;
3. they have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
4. 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 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. they have a known or suspected history of drug or alcohol abuse;
6. they 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. within the past 12 months, they have:
·received more than one injection of influenza vaccine;
9. within the past 6 months, they have:
·had laboratory confirmed influenza disease;
·received influenza vaccine;
10. within the past 4 weeks they have received:
·another vaccine;
·any investigational agent;
11. within the past 7 days, they have experienced:
·any acute disease;
·infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
12. they have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days;
13. within the past 3 days, they have experienced:
·fever (i.e., axillary temperature = 38°C);
14. they are taking part in another clinical study;
15. they 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