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Elimination Criteria and Contraindications to Vaccination

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Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Visit number
Beschrijving

Visit number

Datatype

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Beschrijving

Date of visit

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria
Beschrijving

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period.
Beschrijving

Investigational drug or investigational vaccine during clinical trial period | except for study vaccine

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3854006
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).
Beschrijving

Chronic immunosuppressive agents or biological response modifiers during clinical trial period | except for inhaled steroids | except for topical steroids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C2347804
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C2064827
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.
Beschrijving

Vaccines not indicated by study protocol | Except for DTPw, tetanus, hemophilus influenzae type B, measles and polio vaccines

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012559
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0039620
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0042210
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0025010
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0199809
Administration of immunoglobulins and/or any blood products during the study period.
Beschrijving

Immunoglobulins | blood products during clinical trial period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0456388
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Failure to thrive.
Beschrijving

Failure to thrive

Datatype

boolean

Alias
UMLS CUI [1]
C0015544
Indications for deferral of vaccination
Beschrijving

Indications for deferral of vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0042196
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.
Beschrijving

Acute disease moderate | acute disease severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0001314
UMLS CUI [2,2]
C0205082
Axillary temperature of ≥ 37.5°C.
Beschrijving

Axillary temperature

Datatype

boolean

Alias
UMLS CUI [1]
C1531924
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).
Beschrijving

Diphtheria, tetanus, pertussis (whole-cell), hemophilus influenzae type B, measles, or polio vaccination during vaccine administration period

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012551
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C1948053
UMLS CUI [2,1]
C0039620
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2368628
UMLS CUI [2,4]
C1948053
UMLS CUI [3,1]
C3652513
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C2368628
UMLS CUI [3,4]
C1948053
UMLS CUI [4,1]
C3653328
UMLS CUI [4,2]
C0347984
UMLS CUI [4,3]
C2368628
UMLS CUI [4,4]
C1948053
UMLS CUI [5,1]
C0025010
UMLS CUI [5,2]
C0347984
UMLS CUI [5,3]
C2368628
UMLS CUI [5,4]
C1948053
UMLS CUI [6,1]
C0199809
UMLS CUI [6,2]
C0347984
UMLS CUI [6,3]
C2368628
UMLS CUI [6,4]
C1948053
Absolute contraindications to further vaccination
Beschrijving

Absolute contraindications to further vaccination

Alias
UMLS CUI-1
C0522473
UMLS CUI-2
C0205344
UMLS CUI-3
C0042196
Acute allergic reaction, significant IgE-mediated event or anaphylactic shock following the administration of vaccine investigational product.
Beschrijving

Acute allergic reaction, significant immediate hypersensitivity or anaphylactic shock following investigational vaccination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0413234
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C1517586
UMLS CUI [2,1]
C0020523
UMLS CUI [2,2]
C0750502
UMLS CUI [2,3]
C0042196
UMLS CUI [2,4]
C1517586
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0042196
UMLS CUI [3,3]
C1517586
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beschrijving

Confirmed immunosuppressive or immunodeficient condition | suspected immunosuppressive or immunodeficient condition | HIV infection

Datatype

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
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Similar models

Elimination Criteria and Contraindications to Vaccination

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
clinical visit 2 (2)
(Comment:en)
CL Item
clinical visit 3 (3)
(Comment:en)
CL Item
clinical visit 4 (4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
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])
Item Group
Indications for deferral of vaccination
C0522473 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
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])
Item Group
Absolute contraindications to further vaccination
C0522473 (UMLS CUI-1)
C0205344 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
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])
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