Please select the eligibility criteria that correspond to the clinical trial below.
Title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects
Brief Summary: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.


Options:
A: Inclusion Criteria:

* Persons must be adult men and women aged 18-49 years.
* Persons must be able and willing to provide informed consent.
* Persons must expect to reside in the study area during the entire study period and be interested in participating each year.
* Persons must be willing to receive the licensed live-attenuated vaccine (FluMist) or placebo given as a nasal spray, or the licensed inactivated influenza vaccine (Fluzone or Fluvirin) or placebo given as an intramuscular injection.
* Persons must be willing to provide multiple blood specimens collected by venipuncture each year they are in the study. During each of the first two years of study, blood specimens will be collected three times - at the enrollment visit (immediately prior to administration of vaccine or placebo), at the first follow-up visit 3-5 weeks later, and at the end of the influenza season visit (approximately 4-6 months later); during the third year of the study, blood specimens will be collected twice only, at visits before and after the influenza season.
* Persons must be willing to notify study personnel in the event of influenza-like illness, to provide information on illness symptoms, and to permit collection of a throat culture (swab) specimen for laboratory studies.
* Persons must be willing to not receive an influenza vaccine while participating - other than that (influenza vaccine or placebo) received as study medication.

Exclusion Criteria:

* Persons with any health condition for which the inactivated vaccine is recommended (Advisory Committee on Immunization Practices - ACIP) including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy.
* Persons who are currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
* Persons with hypersensitivity to egg, egg protein, thimerosal (a preservative) or the antibiotic Gentamicin (also know as Garamycin).
* Persons who have had a prior serious reaction to influenza vaccine, or ever had Guillain-Barre syndrome.
* Persons who are living in a household with or have direction occupational contact with immunosuppressed individuals (including health care workers with direct patient contact).
* Persons who have received an influenza vaccine for the influenza season in which they are to be first enrolled or those who plan to receive an influenza vaccine during their participation in the study - other than that (influenza vaccine or placebo) received as study medication.
* Persons who have received any other vaccine within one week prior to enrollment (may delay enrollment).
* Persons who have had a respiratory illness or illness with fever within 3 days of study enrollment (may delay enrollment).
* Persons who are participating in another research study involving any study medications (medicines or vaccines).
B: 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.
C: 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).
D: Inclusion Criteria:

* Participants must be registered with a GPRD 'up to standard' practice during the study period 01/01/1999-31/12/2008
* They must have a record of an incident myocardial infarction (defined by a Read codelist submitted to and agreed by GPRD) that occurs both within their registration and the study period
* They must have at least 6 months between their registration date and the date of the incident MI
* They must have accessed primary care on at least one occasion for a respiratory illness during the study period

Exclusion Criteria:

* Not fulfilling above criteria

Answer: C