Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

Inclusion Criteria:

1. Male and female volunteers of 18 years of age and older, mentally competent, willing
and able to give written informed consent prior to study entry;

2. Individuals able to comply with all the study requirements;

3. Individuals in good health as determined by medical history, physical examination and
clinical judgment of the investigator.

Exclusion Criteria:

1. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
the opinion of the investigator, may interfere with the subject's ability to
participate in the study;

2. Individuals with any serious chronic or acute disease (in the judgment of the
investigator), including but not limited to:

1. Cancer, except for localized skin cancer;

2. Advanced congestive heart failure;

3. Chronic obstructive pulmonary disease (COPD);

4. Autoimmune disease (including rheumatoid arthritis);

5. Acute or progressive hepatic disease;

6. Acute or progressive renal disease;

7. Severe neurological or psychiatric disorder;

8. Severe asthma;

3. Individuals with 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, polymyxin, neomycin);

4. Individuals with 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:

1. 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;

2. receipt of immunostimulants;

3. receipt of parenteral immunoglobulin preparation, blood products and/or plasma
derivates within the past 3 months and for the full length of the study;

4. suspected or known HIV infection or HIV-related disease;

5. Individuals with known or suspected history of drug or alcohol abuse;

6. Individuals with 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. Female who are pregnant or nursing (breastfeeding) mothers or females of childbearing
age do not plan to use acceptable birth control measures, for the duration of the
study. Adequate contraception is defined as hormonal (e.g., oral, injection,
transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or
diaphragm with spermicide), intrauterine device (IUD), or monogamous relationship
with vasectomized partner who has been vasectomized for 6 months or more prior to the
subject's study entry;

8. Individuals who are not able to comprehend and to follow all required study
procedures for the whole period of the study;

9. Individuals that within the past 12 months have received more than one injection of
influenza vaccine;

10. Individuals that within the past 6 months have:

1. had laboratory confirmed seasonal or pandemic influenza disease;

2. received seasonal or pandemic influenza vaccine;

11. Individuals with any acute or chronic infections requiring systemic antibiotic
treatment or antiviral therapy within the last 7 days;

12. Individuals that have experienced fever (i.e., axillary temperature ≥38°C) within the
last 3 days of intended study vaccination;

13. Individuals participating in any clinical trial with another investigational product
4 weeks prior to first study visit or intent to participate in another clinical study
at any time during the conduct of this study;

14. Individuals who received any other vaccines within 4 weeks prior to enrollment in
this study or who are planning to receive any vaccine within 4 weeks from the study
vaccines;

15. Individuals who have received blood, blood products and/or plasma derivatives or any
parenteral immunoglobulin preparation in the past 12 weeks and for the full length of
the study;

16. Individuals who are part of study personnel or close family members conducting this
study;

17. Individuals with history or any illness that, in the opinion of the investigator,
might interfere with the results of the study or pose additional risk to the subjects
due to participation in the study;

18. BMI > 35 kg/m2.