Heterosubtypic Immune Responses to Influenza in Older People

This is an interventional basic science trial for Influenza focused on measuring Influenza, heterosubtypic immune responses Read More

Inclusion Criteria:

1. Subjects aged over 18 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
2. Subjects willing to be enrolled in the vaccine study if appropriate from prescreening blood test results

3. In good health as determined by:

   1. medical history,
   2. physical examination,
   3. clinical judgment of the Investigator;
4. Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits

Exclusion Criteria:

1. Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
2. Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days before Visit 1 or any visit where trial vaccination is planned;
3. Subjects who experienced fever (within 3 days prior to Visit 1;
4. Subjects who are pregnant or breastfeeding;
5. Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study.

6. Subjects with any serious disease, such as:

   1. cancer,
   2. autoimmune disease (including rheumatoid arthritis),
   3. progressive chronic pulmonary disease (stable controlled respiratory disease including asthma is allowed),
   4. acute or progressive hepatic disease,
   5. acute or progressive renal disease;
7. Subjects for whom elective surgery is planned during the study period;
8. Subjects with bleeding diathesis;
9. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
10. Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;

11. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
    2. receipt of immunostimulants,
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
    4. high risk for developing an immunocompromising disease;
12. Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
13. Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;

14. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

    -