Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.
Item
A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.
boolean
C0001779 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0021403 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards).
Item
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards).
boolean
C0085732 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1522577 (UMLS CUI [2])
Written informed consent obtained from the subject.
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Item
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
C0541889 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Item
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
C1301732 (UMLS CUI [3])
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Item
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0031809 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0231921 (UMLS CUI [2])
C1704258 (UMLS CUI [3])
C0678859 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
Immunosuppressive Agents; chronic | Non-Specific Immune-Modulator Therapy | Vaccines | Adrenal Cortex Hormones | prednisone | Inhaled steroids use | Topical form corticosteroids
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0279021 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0586793 (UMLS CUI [6])
C0304604 (UMLS CUI [7])
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Vaccines | Enrollment in clinical trial | Study Protocol
Item
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
boolean
C0042210 (UMLS CUI [1])
C4041024 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
History of hypersensivity to a previous dose of influenza vaccine.
Item
History of hypersensivity to a previous dose of influenza vaccine.
boolean
C0021403 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
History of confirmed influenza infection within the last 12 months.
Item
History of confirmed influenza infection within the last 12 months.
boolean
C0021400 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of allergies | Component (part); Vaccines | Egg Proteins | gelatin | Allergy to formaldehyde | Gentamicins | thimerosal | Chicken antigen | deoxycholic acid, monosodium salt
Item
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
boolean
C0489531 (UMLS CUI [1])
C1705248 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0013700 (UMLS CUI [3])
C0017237 (UMLS CUI [4])
C0571339 (UMLS CUI [5])
C0017436 (UMLS CUI [6])
C0039867 (UMLS CUI [7])
C1443000 (UMLS CUI [8])
C0037500 (UMLS CUI [9])
Acute Disease | Enrollment in clinical trial | Illness (finding); Moderate (severity modifier) | Illness (finding); Severe (severity modifier) | Fever | Administration of vaccine | Diarrhea | Upper Respiratory Infections; Mild (qualifier value) | Acute febrile illness; Low Grade | Body Temperature; Oral | Axillary temperature
Item
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 diarrhea, mild upper respiratory infection with or without low- grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F) / Axillary temperature <37.5°C (99.5°F)).
boolean
C0001314 (UMLS CUI [1])
C4041024 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0221423 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0015967 (UMLS CUI [5])
C2368628 (UMLS CUI [6])
C0011991 (UMLS CUI [7])
C0041912 (UMLS CUI [8,1])
C2945599 (UMLS CUI [8,2])
C0743842 (UMLS CUI [9,1])
C1282907 (UMLS CUI [9,2])
C0005903 (UMLS CUI [10,1])
C0442027 (UMLS CUI [10,2])
C1531924 (UMLS CUI [11])