Please select the eligibility criteria that correspond to the clinical trial below.
Title: Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available Adjuvanted Influenza Vaccine When Administered to Elderly Subjects Part 2: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Immunogenicity and Safety of a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects
Brief Summary: Clinical Trial in Two parts:

Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.

Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.


Options:
A: Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* A man or woman aged 65 years or older at the time of the vaccination.
* Written informed consent obtained from the subject.
* Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

* Bedridden subjects
* Previous vaccination against influenza since February 2008.
* Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Any contra-indication to intramuscular administration of the influenza vaccines.
* History of hypersensitivity to a previous dose of influenza vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein.
* Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature \<37.5°C (99.5°F).
B: Inclusion Criteria:

* Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
C: Inclusion Criteria:

* A male or female 18 years of age or greater at the time of the first vaccination.
* Written informed consent obtained from the subject.
* Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
* Among subjects \> 49 years of age, stable health status within 1 month prior to enrollment.
* Access to a consistent means of telephone contact.
* Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

* Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
* Diagnosed with cancer, or treatment for cancer, within 3 years.
* An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection.
* Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Administration of any vaccines within 30 days before study enrollment.
* Previous administration of any H5N1 vaccine.
* Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
* Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to either vaccination.
* Lactating or nursing.
* Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
* Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
D: Inclusion Criteria:

* who are and aged at least 60 years or older at the time of enrollment;
* who are determined by medical history, physical examination and clinical judgement to be eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible.
* who have provided written informed consent after the nature of the study has been explained;
* who, will be available for duration of the trial (from enrollment to approximately November 30, 2001); who can be reached by study staff for the post-vaccination and weekly surveillance contacts \[telephone, clinic or home visit\].

Exclusion Criteria:

* who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
* who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to study manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial.
* With evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to study manual).
* with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents;
* who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study;
* have an immunosuppressed or an immunocompromised individual living in the same household;
* with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
* who were administered any live virus vaccine within one month prior to enrollment or expected to receive another live virus vaccine within one month of vaccination in this study;
* for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study;
* who, received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
* who receive any influenza vaccine in the 6 months to enrollment, or a non-study influenza vaccine since enrollment;
* with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment

Answer: B