Investigational drug or investigational vaccine during clinical trial period | except for study vaccine
Item
Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3854006 (UMLS CUI [3,2])
Chronic immunosuppressive agents or biological response modifiers during clinical trial period | except for inhaled steroids | except for topical steroids
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period (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])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Vaccines not indicated by study protocol | Except for DTPw, tetanus, hemophilus influenzae type B, measles and polio vaccines
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before Dose 1 and ending 30 days after Dose 3 with the exception of vaccines for DTPw, Tetanus, Hemophilus influenzae type B, Measles, and Polio, for which a 14 day interval around the dose of a study vaccine will be applied.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
C1705847 (UMLS CUI [2,1])
C0012559 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0039620 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0042210 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0025010 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0199809 (UMLS CUI [6,2])
Immunoglobulins | blood products during clinical trial period
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0456388 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Failure to thrive
Item
Failure to thrive.
boolean
C0015544 (UMLS CUI [1])
Acute disease moderate | acute disease severe
Item
Acute disease at the time of administration of investigational product (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 or mild upper respiratory infection without fever, i.e. Axillary temperature < 37.5°C.
boolean
C0001314 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0001314 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Axillary temperature
Item
Axillary temperature of ≥ 37.5°C.
boolean
C1531924 (UMLS CUI [1])
Diphtheria, tetanus, pertussis (whole-cell), hemophilus influenzae type B, measles, or polio vaccination during vaccine administration period
Item
Diphtheria, Tetanus, Pertussis (whole-cell), Hemophilus influenzae type B, Measles, or Polio vaccination within 14 days of any trial vaccination (i.e. RTS,S/AS01E or Rabies Vaccine).
boolean
C0012551 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C1948053 (UMLS CUI [1,4])
C0039620 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2368628 (UMLS CUI [2,3])
C1948053 (UMLS CUI [2,4])
C3652513 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C2368628 (UMLS CUI [3,3])
C1948053 (UMLS CUI [3,4])
C3653328 (UMLS CUI [4,1])
C0347984 (UMLS CUI [4,2])
C2368628 (UMLS CUI [4,3])
C1948053 (UMLS CUI [4,4])
C0025010 (UMLS CUI [5,1])
C0347984 (UMLS CUI [5,2])
C2368628 (UMLS CUI [5,3])
C1948053 (UMLS CUI [5,4])
C0199809 (UMLS CUI [6,1])
C0347984 (UMLS CUI [6,2])
C2368628 (UMLS CUI [6,3])
C1948053 (UMLS CUI [6,4])
Acute allergic reaction, significant immediate hypersensitivity or anaphylactic shock following investigational vaccination
Item
Acute allergic reaction, significant IgE-mediated event or anaphylactic shock following the administration of vaccine investigational product.
boolean
C0413234 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C0020523 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C1517586 (UMLS CUI [2,4])
C0002792 (UMLS CUI [3,1])
C0042196 (UMLS CUI [3,2])
C1517586 (UMLS CUI [3,3])
Confirmed immunosuppressive or immunodeficient condition | suspected immunosuppressive or immunodeficient condition | HIV infection
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])