ID
35687
Description
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 Collaborators: N/A 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
Keywords
Versions (1)
- 3/15/19 3/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 15, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)
Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
Description
Solicited Adverse Experiences - Local Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C1457887
- UMLS CUI-3
- C0205276
Description
Has the Diary Card been returned?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3890583
- UMLS CUI [1,2]
- C0332156
Description
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0037088
- UMLS CUI [1,2]
- C0205276
Description
Local Symptoms
Alias
- UMLS CUI-1
- C1457887
- UMLS CUI-2
- C0205276
Description
Please tick box of experienced symptom.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205276
- UMLS CUI [2]
- C2700396
Description
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Description
Pain intensity (Day 0, 5-9 hours)
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Redness/ Swelling - Size in mm (Day 1)
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Description
Pain intensity (Day 1)
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Redness/ Swelling - Size in mm (Day 2)
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Description
Pain intensity (Day 2)
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
Redness/ Swelling - Size in mm (Day 3)
Data type
float
Measurement units
- mm
Alias
- UMLS CUI [1,1]
- C0332575
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2,1]
- C0038999
- UMLS CUI [2,2]
- C0456389
Description
Pain intensity (Day 3)
Data type
integer
Alias
- UMLS CUI [1]
- C1320357
Description
If ongoing after Day 3 - Date of last day of symptom
Data type
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
Description
Solicited Adverse Experiences - General Symptoms
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C0159028
Description
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0159028
Description
General Symptoms - Only for children from 1 to 5 years old
Alias
- UMLS CUI-1
- C0159028
Description
Please tick box of experienced symptom.
Data type
integer
Alias
- UMLS CUI [1]
- C0159028
Description
Fever (Day 0, 5-9 hours)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 0, 5-9 hours)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
Data type
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
Description
Fever (Day 1
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 1)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
Data type
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
Description
Fever (Day 2)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 2)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
Data type
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
Description
Fever (Day 3)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 3)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Relationship
Data type
text
Alias
- UMLS CUI [1]
- C0439849
Description
If ongoing after Day 3 - Date of last day of symptoms
Data type
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
Description
General Symptoms - Only for children from 6 to 11 years old
Alias
- UMLS CUI-1
- C0159028
Description
Please tick box of experienced symptom.
Data type
integer
Alias
- UMLS CUI [1]
- C0159028
Description
Fever (Day 0, 5-9 hours)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 0, 5-9 hours)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
Data type
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
Description
Fever (Day 1)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 1)
Data type
float
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
Data type
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
Description
Fever (Day 2)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 2)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
Data type
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
Description
Fever (Day 3)
Data type
integer
Alias
- UMLS CUI [1]
- C0015967
Description
Temperature (Day 3)
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1]
- C0005903
Description
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
Data type
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
Description
Relationship
Data type
text
Alias
- UMLS CUI [1]
- C0439849
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Visit 1 Dose 1 - Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
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C0304229 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
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C2348563 (UMLS CUI [1,3])
C0593953 (UMLS CUI [1,4])
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C0332156 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
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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])
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C0038999 (UMLS CUI [2,1])
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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])
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C0522510 (UMLS CUI [2,2])
C0426576 (UMLS CUI [3,1])
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C0522510 (UMLS CUI [3,2])