ID
29348
Beskrivning
Visit 2 Study ID: 101695 Ext. Mth30 Clinical Study ID: 101695 Study Title: Long-term study of immune response persistence of GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines in subjects aged 11-15 yrs Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00343915 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Nyckelord
Versioner (1)
- 2018-03-20 2018-03-20 -
Rättsinnehavare
GlaxoSmithKline (GSK)
Uppladdad den
20 mars 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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GSK Biologicals' 2-dose thiomersal-free Engerix™-B and 3-dose preservative-free Engerix™-B vaccines Study ID: 101695 NCT00343915
Visit 2, Month 1, 30 + 10 days after Visit 1, Dose 2
- StudyEvent: ODM
Beskrivning
Pre-vaccination assessment
Alias
- UMLS CUI-1
- C0220825
- UMLS CUI-2
- C0042196
Beskrivning
Temperature
Datatyp
integer
Alias
- UMLS CUI [1]
- C0039476
Beskrivning
Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1515974
Beskrivning
URINE SAMPLE (Pregnancy test – HCG) (only if deemed necessary by the investigator).
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0200354
Beskrivning
Urine sample results, Pregnancy
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0456984
- UMLS CUI [2]
- C0430056
Beskrivning
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Beskrivning
Vaccine administration
Datatyp
integer
Alias
- UMLS CUI [1]
- C2368628
Beskrivning
Side / site Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beskrivning
Vaccine administration according to protocol
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beskrivning
If you answered the previous question with 'No', please check all items:
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0042210
Beskrivning
Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beskrivning
Comments
Datatyp
text
Alias
- UMLS CUI [1]
- C0947611
Beskrivning
Solicited adverse events - Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C0042196
Beskrivning
Redness
Alias
- UMLS CUI-1
- C0332575
- UMLS CUI-2
- C2700396
Beskrivning
Redness
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C2700396
Beskrivning
Redness day
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0332575
Beskrivning
Redness size
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Ongoing redness
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beskrivning
If you answered the previous question with yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0332575
- UMLS CUI [1,3]
- C2700396
Beskrivning
Swelling
Alias
- UMLS CUI-1
- C0038999
- UMLS CUI-2
- C2700396
Beskrivning
Swelling
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038999
Beskrivning
Swelling day
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0038999
Beskrivning
Swelling size
Datatyp
integer
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [1,3]
- C2700396
Beskrivning
Ongoing swelling
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0038999
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beskrivning
If you answered the previous question with yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0038999
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
- UMLS CUI-3
- C2700396
Beskrivning
Pain
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [1,3]
- C2700396
Beskrivning
Pain day
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0030193
Beskrivning
Pain intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [1,3]
- C2700396
Beskrivning
Ongoing pain
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0030193
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [1,3]
- C2700396
Beskrivning
If you answered the previous question with yes, please specify
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0030193
- UMLS CUI [1,3]
- C2700396
Beskrivning
Solicited adverse events - General symptoms
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C0042196
- UMLS CUI-3
- C0877248
Beskrivning
Fever
Alias
- UMLS CUI-1
- C0015967
Beskrivning
Axillary > 37.5°C Oral > 37.5°C Rectal > 38°C
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Route
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C1515974
Beskrivning
Fever not taken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Fever Day
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Beskrivning
Fever Day
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0439228
Beskrivning
Temperature
Datatyp
integer
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Ongoing fever
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last fever symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0015967
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0015967
Beskrivning
Fatigue
Alias
- UMLS CUI-1
- C0015672
Beskrivning
Fatigue
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue day
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015672
Beskrivning
Fatigue intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0522510
Beskrivning
Ongoing fatigue
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last fatigue symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0015672
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0015672
Beskrivning
Headache
Alias
- UMLS CUI-1
- C0018681
Beskrivning
Headache
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache day
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018681
Beskrivning
Headache Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
Beskrivning
Ongoing headache
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last headache symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1457887
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0018681
Beskrivning
Gastrointestinal symptoms
Alias
- UMLS CUI-1
- C0426576
Beskrivning
Gastrointestinal symptoms
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms Day
Datatyp
integer
Alias
- UMLS CUI [1]
- C0426576
Beskrivning
Gastrointestinal symptoms Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0522510
Beskrivning
Ongoing Gastrointestinal symptoms
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0426576
- UMLS CUI [1,2]
- C0549178
Beskrivning
Date of last Gastrointestinal symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0426576
Beskrivning
Causality
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0015127
- UMLS CUI [1,2]
- C0426576
Similar models
Visit 2, Month 1, 30 + 10 days after Visit 1, Dose 2
- StudyEvent: ODM
C0042196 (UMLS CUI-2)
C0456984 (UMLS CUI [1,2])
C0430056 (UMLS CUI [2])
C0042210 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0015967 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0015672 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
C0018681 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,2])
C0426576 (UMLS CUI [1,2])