ID
35693
Beskrivning
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Nyckelord
Versioner (1)
- 2019-03-15 2019-03-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 mars 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C0430022
Beskrivning
Baseline Temperature
Alias
- UMLS CUI-1
- C0005903
- UMLS CUI-2
- C1442488
Beskrivning
Baseline Assessment - General Symptoms
Alias
- UMLS CUI-1
- C1442488
- UMLS CUI-2
- C1516048
- UMLS CUI-3
- C0159028
Beskrivning
Does the subject experience any of the following general solicited signs or symptoms just before injection?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0159028
- UMLS CUI [1,2]
- C1533685
- UMLS CUI [1,3]
- C0332152
Beskrivning
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Beskrivning
General Symptoms Observed Just Before Injection
Alias
- UMLS CUI-1
- C0159028
- UMLS CUI-2
- C1533685
- UMLS CUI-3
- C0332152
Beskrivning
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beskrivning
If no, please specify reason:
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
Beskrivning
Reason for study vaccine not been administered
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1272696
- UMLS CUI [1,4]
- C0392360
Beskrivning
Please tick appropriate box.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0441987
- UMLS CUI [2,1]
- C2368628
- UMLS CUI [2,2]
- C0304229
- UMLS CUI [2,3]
- C1515974
- UMLS CUI [3]
- C0013153
Beskrivning
If no, recod Site and Route
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C2348563
- UMLS CUI [1,4]
- C0593953
Beskrivning
If study vaccine has not been administered according to the protocol, record Site of Administration.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1515974
Beskrivning
If study vaccine has not been administered according to the protocol, record Route of Administration.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C0013153
Beskrivning
Solicited Adverse Experiences - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Beskrivning
Has the Diary Card been returned?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Beskrivning
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
Beskrivning
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Beskrivning
Please tick box of experienced symptom.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [2]
- C2700396
Beskrivning
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 0, 5-9 hours)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 1)
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 1)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 2)
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
Redness/ Swelling - Size in mm (Day 3)
Datatyp
float
Måttenheter
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Beskrivning
Pain intensity (Day 3)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1320357
Beskrivning
If ongoing after Day 3 - Date of last day of symptom
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
Solicited Adverse Experiences - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Beskrivning
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Beskrivning
General Symptoms - Only for children from 1 to 5 years old
Alias
- UMLS CUI-1
- C0159028
Beskrivning
Please tick box of experienced symptom.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0159028
Beskrivning
Fever (Day 0, 5-9 hours)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 0, 5-9 hours)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0013144
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C1971624
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 1
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 1)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0013144
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C1971624
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 2)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0022107
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0013144
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C1971624
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 3)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 3)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Relationship
Datatyp
text
Alias
- UMLS CUI [1]
- C0439849
Beskrivning
If ongoing after Day 3 - Date of last day of symptoms
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C1517741
- UMLS CUI [2,3]
- C1457887
Beskrivning
General Symptoms - Only for children from 6 to 11 years old
Alias
- UMLS CUI-1
- C0159028
Beskrivning
Please tick box of experienced symptom.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0159028
Beskrivning
Fever (Day 0, 5-9 hours)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 0, 5-9 hours)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0015672
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C0426576
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 1)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 1)
Datatyp
float
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0015672
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C0426576
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 2)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0015672
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C0426576
- UMLS CUI [3,2]
- C0522510
Beskrivning
Fever (Day 3)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0015967
Beskrivning
Temperature (Day 3)
Datatyp
float
Måttenheter
- °C
Alias
- UMLS CUI [1]
- C0005903
Beskrivning
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018681
- UMLS CUI [1,2]
- C0522510
- UMLS CUI [2,1]
- C0015672
- UMLS CUI [2,2]
- C0522510
- UMLS CUI [3,1]
- C0426576
- UMLS CUI [3,2]
- C0522510
Beskrivning
Relationship
Datatyp
text
Alias
- UMLS CUI [1]
- C0439849
Similar models
Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0013153 (UMLS CUI [3])
C0304229 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0593953 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C0332156 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0522510 (UMLS CUI [1,2])
C0013144 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C1971624 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])
C0522510 (UMLS CUI [1,2])
C0015672 (UMLS CUI [2,1])
C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
C0522510 (UMLS CUI [3,2])