ID

42740

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00944034

Länk

http://clinicaltrials.gov/show/NCT00944034

Nyckelord

Versioner (2)
  1. 2013-12-09 2013-12-09 - Martin Dugas
  2. 2021-09-17 2021-09-17 -
Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility NCT00944034 Meningococcal Disease

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

Alias
UMLS CUI 2011AA
CL425202
Alter 12 bis 24 Monate
Beskrivning

age 12 Months to 24 Months

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Meningococcal Disease
Beskrivning

Meningococcal Disease

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0025303
SNOMED CT 2011_0131
23511006
MedDRA 14.1
10027274
ICD-10-CM Version 2010
A39.9
ICD-9-CM Version 2011
036.9
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
Follow-on participants of V72P12:
Beskrivning

Follow-on participants of V72P12:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0679646
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332282
SNOMED CT 2011_0131
255260001
Healthy toddlers who completed Study V72P12, aged:
Beskrivning

Healthy toddlers who completed Study V72P12, aged:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0018684
SNOMED CT 2011_0131
263775005
UMLS CUI 2011AA
C0682053
UMLS CUI 2011AA
C1556116
HL7 V3 2006_05
completed
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
12 months or older - Groups 1a, 2a, 3a, 4
Beskrivning

12 months or older - Groups 1a, 2a, 3a, 4

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0441862
SNOMED CT 2011_0131
258367000
UMLS CUI 2011AA
C0441866
SNOMED CT 2011_0131
258371002
UMLS CUI 2011AA
C0441870
SNOMED CT 2011_0131
258375006
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
Beskrivning

18 months (0/ +29 days window) - Groups 1b, 2b, 3b

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL414962
UMLS CUI 2011AA
C0441863
SNOMED CT 2011_0131
258368005
UMLS CUI 2011AA
C0441867
SNOMED CT 2011_0131
258372009
UMLS CUI 2011AA
C0441871
SNOMED CT 2011_0131
258376007
24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Beskrivning

24 months (0/ +29 days window) - Groups 1c, 2c, 3c

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL414962
UMLS CUI 2011AA
C0441864
SNOMED CT 2011_0131
258369002
UMLS CUI 2011AA
C0441868
SNOMED CT 2011_0131
258373004
UMLS CUI 2011AA
C0441872
SNOMED CT 2011_0131
258377003
Naive subjects newly enrolled:
Beskrivning

Naive subjects newly enrolled:

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
CL415147
UMLS CUI 2011AA
C0681850
UMLS CUI 2011AA
C0205314
SNOMED CT 2011_0131
7147002
UMLS CUI 2011AA
C1516879
Group 5: healthy 18-month-old toddlers (0/ +29 days window)
Beskrivning

Group 5: healthy 18-month-old toddlers (0/ +29 days window)

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0018684
SNOMED CT 2011_0131
263775005
UMLS CUI 2011AA
C0682053
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL414962
Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Beskrivning

Group 6: healthy 24-month-old toddlers (0/ +29 days window)

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0018684
SNOMED CT 2011_0131
263775005
UMLS CUI 2011AA
C0682053
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
CL414962
Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Alias
UMLS CUI 2011AA
CL425201
History of any meningococcal B vaccine administration (only for groups 5 and 6)
Beskrivning

History of any meningococcal B vaccine administration (only for groups 5 and 6)

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0025303
SNOMED CT 2011_0131
23511006
MedDRA 14.1
10027274
ICD-10-CM Version 2010
A39.9
ICD-9-CM Version 2011
036.9
UMLS CUI 2011AA
C0441836
SNOMED CT 2011_0131
272415008
UMLS CUI 2011AA
C2368628
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0205451
SNOMED CT 2011_0131
34001005
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
Previous ascertained or suspected disease caused by N. meningitidis
Beskrivning

Previous ascertained or suspected disease caused by N. meningitidis

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C0027575
SNOMED CT 2011_0131
17872004
LOINC Version 232
MTHU006713
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Beskrivning

History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component

Datatyp

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C1527304
SNOMED CT 2011_0131
421668005
MedDRA 14.1
10001718
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0042196
SNOMED CT 2011_0131
33879002
MedDRA 14.1
10046859
LOINC Version 232
MTHU000146
UMLS CUI 2011AA
C0455593
SNOMED CT 2011_0131
161595008
Significant acute or chronic infection within the previous 7 days or axillary temperature >=38 degrees within the previous day
Beskrivning

Significant acute or chronic infection within the previous 7 days or axillary temperature >=38 degrees within the previous day

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C0009450
SNOMED CT 2011_0131
257551009
MedDRA 14.1
10021789
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C1531924
SNOMED CT 2011_0131
415882003
UMLS CUI 2011AA
C0449286
SNOMED CT 2011_0131
246173007
Antibiotics within 6 days prior to enrollment
Beskrivning

Antibiotics within 6 days prior to enrollment

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0003232
SNOMED CT 2011_0131
255631004
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1516879
Any serious chronic or progressive disease
Beskrivning

Any serious chronic or progressive disease

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0205404
SNOMED CT 2011_0131
42745003
UMLS CUI 2011AA
C0008679
SNOMED CT 2011_0131
27624003
UMLS CUI 2011AA
C1335499
Known or suspected impairment or alteration of the immune system
Beskrivning

Known or suspected impairment or alteration of the immune system

Datatyp

boolean

Alias
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C1515926
UMLS CUI 2011AA
C0020962
SNOMED CT 2011_0131
116003000
LOINC Version 232
MTHU013246
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Beskrivning

Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.

Datatyp

boolean

Alias
UMLS CUI 2011AA
C1514756
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0456388
SNOMED CT 2011_0131
410652009
HL7 V3 2006_05
BLDPRD
UMLS CUI 2011AA
C2964352
LOINC Version 232
MTHU036409
UMLS CUI 2011AA
C1518896
UMLS CUI 2011AA
C0021027
SNOMED CT 2011_0131
399771004
HL7 V3 2006_05
14
UMLS CUI 2011AA
C0013227
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age 12 Months to 24 Months
Item
Alter 12 bis 24 Monate
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Meningococcal Disease
Item
Meningococcal Disease
boolean
C0025303 (UMLS CUI 2011AA)
23511006 (SNOMED CT 2011_0131)
10027274 (MedDRA 14.1)
A39.9 (ICD-10-CM Version 2010)
036.9 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Follow-on participants of V72P12:
Item
Follow-on participants of V72P12:
boolean
C0679646 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332282 (UMLS CUI 2011AA)
255260001 (SNOMED CT 2011_0131)
Healthy toddlers who completed Study V72P12, aged:
Item
Healthy toddlers who completed Study V72P12, aged:
boolean
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0682053 (UMLS CUI 2011AA)
C1556116 (UMLS CUI 2011AA)
completed (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
12 months or older - Groups 1a, 2a, 3a, 4
Item
12 months or older - Groups 1a, 2a, 3a, 4
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0441862 (UMLS CUI 2011AA)
258367000 (SNOMED CT 2011_0131)
C0441866 (UMLS CUI 2011AA)
258371002 (SNOMED CT 2011_0131)
C0441870 (UMLS CUI 2011AA)
258375006 (SNOMED CT 2011_0131)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
Item
18 months (0/ +29 days window) - Groups 1b, 2b, 3b
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL414962 (UMLS CUI 2011AA)
C0441863 (UMLS CUI 2011AA)
258368005 (SNOMED CT 2011_0131)
C0441867 (UMLS CUI 2011AA)
258372009 (SNOMED CT 2011_0131)
C0441871 (UMLS CUI 2011AA)
258376007 (SNOMED CT 2011_0131)
24 months (0/ +29 days window) - Groups 1c, 2c, 3c
Item
24 months (0/ +29 days window) - Groups 1c, 2c, 3c
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL414962 (UMLS CUI 2011AA)
C0441864 (UMLS CUI 2011AA)
258369002 (SNOMED CT 2011_0131)
C0441868 (UMLS CUI 2011AA)
258373004 (SNOMED CT 2011_0131)
C0441872 (UMLS CUI 2011AA)
258377003 (SNOMED CT 2011_0131)
Naive subjects newly enrolled:
Item
Naive subjects newly enrolled:
boolean
C1518422 (UMLS CUI 2011AA)
CL415147 (UMLS CUI 2011AA)
C0681850 (UMLS CUI 2011AA)
C0205314 (UMLS CUI 2011AA)
7147002 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Group 5: healthy 18-month-old toddlers (0/ +29 days window)
Item
Group 5: healthy 18-month-old toddlers (0/ +29 days window)
boolean
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0682053 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL414962 (UMLS CUI 2011AA)
Group 6: healthy 24-month-old toddlers (0/ +29 days window)
Item
Group 6: healthy 24-month-old toddlers (0/ +29 days window)
boolean
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0018684 (UMLS CUI 2011AA)
263775005 (SNOMED CT 2011_0131)
C0682053 (UMLS CUI 2011AA)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
CL414962 (UMLS CUI 2011AA)
Item Group
Ausschlusskriterien
CL425201 (UMLS CUI 2011AA)
History of any meningococcal B vaccine administration (only for groups 5 and 6)
Item
History of any meningococcal B vaccine administration (only for groups 5 and 6)
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0025303 (UMLS CUI 2011AA)
23511006 (SNOMED CT 2011_0131)
10027274 (MedDRA 14.1)
A39.9 (ICD-10-CM Version 2010)
036.9 (ICD-9-CM Version 2011)
C0441836 (UMLS CUI 2011AA)
272415008 (SNOMED CT 2011_0131)
C2368628 (UMLS CUI 2011AA)
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0205451 (UMLS CUI 2011AA)
34001005 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
Previous ascertained or suspected disease caused by N. meningitidis
Item
Previous ascertained or suspected disease caused by N. meningitidis
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C0027575 (UMLS CUI 2011AA)
17872004 (SNOMED CT 2011_0131)
MTHU006713 (LOINC Version 232)
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Item
History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C1527304 (UMLS CUI 2011AA)
421668005 (SNOMED CT 2011_0131)
10001718 (MedDRA 14.1)
T78.40 (ICD-10-CM Version 2010)
C0042196 (UMLS CUI 2011AA)
33879002 (SNOMED CT 2011_0131)
10046859 (MedDRA 14.1)
MTHU000146 (LOINC Version 232)
C0455593 (UMLS CUI 2011AA)
161595008 (SNOMED CT 2011_0131)
Significant acute or chronic infection within the previous 7 days or axillary temperature >=38 degrees within the previous day
Item
Significant acute or chronic infection within the previous 7 days or axillary temperature >=38 degrees within the previous day
boolean
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0009450 (UMLS CUI 2011AA)
257551009 (SNOMED CT 2011_0131)
10021789 (MedDRA 14.1)
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C1531924 (UMLS CUI 2011AA)
415882003 (SNOMED CT 2011_0131)
C0449286 (UMLS CUI 2011AA)
246173007 (SNOMED CT 2011_0131)
Antibiotics within 6 days prior to enrollment
Item
Antibiotics within 6 days prior to enrollment
boolean
C0003232 (UMLS CUI 2011AA)
255631004 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Any serious chronic or progressive disease
Item
Any serious chronic or progressive disease
boolean
C0205404 (UMLS CUI 2011AA)
42745003 (SNOMED CT 2011_0131)
C0008679 (UMLS CUI 2011AA)
27624003 (SNOMED CT 2011_0131)
C1335499 (UMLS CUI 2011AA)
Known or suspected impairment or alteration of the immune system
Item
Known or suspected impairment or alteration of the immune system
boolean
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C1515926 (UMLS CUI 2011AA)
C0020962 (UMLS CUI 2011AA)
116003000 (SNOMED CT 2011_0131)
MTHU013246 (LOINC Version 232)
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
Item
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.
boolean
C1514756 (UMLS CUI 2011AA)
C0005768 (UMLS CUI 2011AA)
C0456388 (UMLS CUI 2011AA)
410652009 (SNOMED CT 2011_0131)
BLDPRD (HL7 V3 2006_05)
C2964352 (UMLS CUI 2011AA)
MTHU036409 (LOINC Version 232)
C1518896 (UMLS CUI 2011AA)
C0021027 (UMLS CUI 2011AA)
399771004 (SNOMED CT 2011_0131)
14 (HL7 V3 2006_05)
C0013227 (UMLS CUI 2011AA)
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