Informatie:
Fout:
ID
35693
Beschrijving
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
Trefwoorden
Versies (1)
- 15-03-19 15-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 maart 2019
DOI
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Licentie
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 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
Similar models
Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C1277698 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
CL Item
Axillary (1)
CL Item
Oral (applicable for all ages) (2)
CL Item
Rectal (applicable to 1 to 5 years old) (3)
Item Group
Baseline Assessment - General Symptoms
C1442488 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C1516048 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
Does the subject experience any of the following general solicited signs or symptoms just before injection?
Item
Does the subject experience any of the following general solicited signs or symptoms just before injection?
boolean
C0159028 (UMLS CUI [1,1])
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1533685 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
CL Item
Irritability/ Fussiness (1)
CL Item
Drowsiness (2)
CL Item
Loss of appetite (3)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
CL Item
Headache (1)
CL Item
Fatigue (2)
CL Item
Gastrointestinal symptoms (3)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Has the study vaccine been administered?
Item
Has the study vaccine been administered?
boolean
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
Reason for study vaccine not been administered
Item
Reason for study vaccine not been administered
text
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Item
If study Vaccine (Twinrix Vaccine) has been administered, record Side/ Site Route
integer
C2368628 (UMLS CUI [1,1])
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])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1515974 (UMLS CUI [2,3])
C0013153 (UMLS CUI [3])
Code List
If study Vaccine (Twinrix Vaccine) has been administered, record Side/ Site Route
CL Item
Deltoid i.m. left (1)
CL Item
Deltoid i.m. right (2)
Has the study vaccine been administered according to the protocol?
Item
If study Vaccine (Twinrix Vaccine) has been administered, has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0593953 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0593953 (UMLS CUI [1,4])
If study vaccine has not been administered according to the protocol, record Site of Administration.
Item
If study vaccine has not been administered according to the protocol, record Site of Administration.
integer
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
Code List
If study vaccine has not been administered according to the protocol, record Site of Administration.
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If study vaccine has not been administered according to the protocol, record Route of Administration.
integer
C2368628 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Code List
If study vaccine has not been administered according to the protocol, record Route of Administration.
CL Item
i.m. (1)
CL Item
s.c (2)
Item Group
Solicited Adverse Experiences - Local Symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Has the Diary Card been returned?
Item
Has the Diary Card been returned?
boolean
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0332156 (UMLS CUI [1,2])
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
Item
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
boolean
C0037088 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,2])
Item
Local Symptoms (at the injection site)
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
Item
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
float
C0332575 (UMLS CUI [1,1])
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])
Item
Pain intensity (Day 0, 5-9 hours)
integer
C1320357 (UMLS CUI [1])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Redness/ Swelling - Size in mm (Day 1)
Item
Redness/ Swelling - Size in mm (Day 1)
float
C0332575 (UMLS CUI [1,1])
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])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Redness/ Swelling - Size in mm (Day 2)
Item
Redness/ Swelling - Size in mm (Day 2)
float
C0332575 (UMLS CUI [1,1])
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])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Redness/ Swelling - Size in mm (Day 3)
Item
Redness/ Swelling - Size in mm (Day 3)
float
C0332575 (UMLS CUI [1,1])
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])
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
If ongoing after Day 3 - Date of last day of symptom
Item
If ongoing after Day 3 - Date of last day of symptom
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
Solicited Adverse Experiences - General Symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
C0159028 (UMLS CUI-2)
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
Item
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
boolean
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,2])
Item Group
General Symptoms - Only for children from 1 to 5 years old
C0159028 (UMLS CUI-1)
CL Item
Fever (1)
CL Item
Irratibility/ Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
CL Item
Axillary (>= 37,5°C) (1)
CL Item
Oral (>= 37,5°C) (2)
CL Item
Rectal (>= 38°C) (3)
CL Item
Not taken (4)
Temperature (Day 0, 5-9 hours)
Item
Temperature (Day 0, 5-9 hours)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
integer
C0022107 (UMLS CUI [1,1])
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])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
CL Item
Not taken (4)
Temperature (Day 1)
Item
Temperature (Day 1)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
integer
C0022107 (UMLS CUI [1,1])
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])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
CL Item
Not taken (4)
Temperature (Day 2)
Item
Temperature (Day 2)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
integer
C0022107 (UMLS CUI [1,1])
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])
Code List
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
CL Item
Rectal (>= 38 °C) (3)
CL Item
Not taken (4)
Temperature (Day 3)
Item
Temperature (Day 3)
float
C0005903 (UMLS CUI [1])
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected (SU)
CL Item
Probable (PB)
If ongoing after Day 3 - Date of last day of symptoms
Item
If ongoing after Day 3 - Date of last day of symptoms
date
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0549178 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
Item Group
General Symptoms - Only for children from 6 to 11 years old
C0159028 (UMLS CUI-1)
CL Item
Fever (1)
CL Item
Headache (2)
CL Item
Fatigue (3)
CL Item
Gastrointestinal symptoms (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 0, 5-9 hours)
Item
Temperature (Day 0, 5-9 hours)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
integer
C0018681 (UMLS CUI [1,1])
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])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 1)
Item
Temperature (Day 1)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
integer
C0018681 (UMLS CUI [1,1])
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])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 2)
Item
Temperature (Day 2)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
integer
C0018681 (UMLS CUI [1,1])
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])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Axillary (>= 37,5 °C) (1)
CL Item
Oral (>= 37,5 °C) (2)
Temperature (Day 3)
Item
Temperature (Day 3)
float
C0005903 (UMLS CUI [1])
Item
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
integer
C0018681 (UMLS CUI [1,1])
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])
Code List
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected PB=Probable (SU)