ID

35693

Beschreibung

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

Stichworte

Versionen (1)
  1. 15.03.19 15.03.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. März 2019

DOI

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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Englisch

Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Visit
Beschreibung

Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0430022
Has a blood sample been taken ?
Beschreibung

Has a blood sample been taken ?

Datentyp

boolean

Alias
UMLS CUI [1]
C1277698
Baseline Temperature
Beschreibung

Baseline Temperature

Alias
UMLS CUI-1
C0005903
UMLS CUI-2
C1442488
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Beschreibung

Route

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0449687
Baseline Assessment - General Symptoms
Beschreibung

Baseline Assessment - General Symptoms

Alias
UMLS CUI-1
C1442488
UMLS CUI-2
C1516048
UMLS CUI-3
C0159028
Does the subject experience any of the following general solicited signs or symptoms just before injection?
Beschreibung

Does the subject experience any of the following general solicited signs or symptoms just before injection?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C1533685
UMLS CUI [1,3]
C0332152
General Symptoms Observed Just Before Injection
Beschreibung

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Beschreibung

Only for children from 1 to 5 Years old

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
General Symptoms Observed Just Before Injection
Beschreibung

General Symptoms Observed Just Before Injection

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C1533685
UMLS CUI-3
C0332152
Symptom
Beschreibung

Only for Children from 6 to 11 Years old

Datentyp

integer

Alias
UMLS CUI [1]
C1457887
Intensity
Beschreibung

Intensity

Datentyp

integer

Alias
UMLS CUI [1]
C0518690
Vaccine Administration
Beschreibung

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Has the study vaccine been administered?
Beschreibung

If no, please specify reason:

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
Reason for study vaccine not been administered
Beschreibung

Reason for study vaccine not been administered

Datentyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1272696
UMLS CUI [1,4]
C0392360
If study Vaccine (Twinrix Vaccine) has been administered, record Side/ Site Route
Beschreibung

Please tick appropriate box.

Datentyp

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
If study Vaccine (Twinrix Vaccine) has been administered, has the study vaccine been administered according to the protocol?
Beschreibung

If no, recod Site and Route

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0593953
If study vaccine has not been administered according to the protocol, record Site of Administration.
Beschreibung

If study vaccine has not been administered according to the protocol, record Site of Administration.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1515974
If study vaccine has not been administered according to the protocol, record Route of Administration.
Beschreibung

If study vaccine has not been administered according to the protocol, record Route of Administration.

Datentyp

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C0013153
Solicited Adverse Experiences - Local Symptoms
Beschreibung

Solicited Adverse Experiences - Local Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the Diary Card been returned?
Beschreibung

Has the Diary Card been returned?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?
Beschreibung

Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period ?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0205276
Local Symptoms
Beschreibung

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Local Symptoms (at the injection site)
Beschreibung

Please tick box of experienced symptom.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C2700396
Redness/ Swelling - Size in mm (Day 0, 5-9 hours)
Beschreibung

Redness/ Swelling - Size in mm (Day 0, 5-9 hours)

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
mm
Pain intensity (Day 0, 5-9 hours)
Beschreibung

Pain intensity (Day 0, 5-9 hours)

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Redness/ Swelling - Size in mm (Day 1)
Beschreibung

Redness/ Swelling - Size in mm (Day 1)

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
mm
Pain intensity (Day 1)
Beschreibung

Pain intensity (Day 1)

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Redness/ Swelling - Size in mm (Day 2)
Beschreibung

Redness/ Swelling - Size in mm (Day 2)

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
mm
Pain intensity (Day 2)
Beschreibung

Pain intensity (Day 2)

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
Redness/ Swelling - Size in mm (Day 3)
Beschreibung

Redness/ Swelling - Size in mm (Day 3)

Datentyp

float

Maßeinheiten
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
mm
Pain intensity (Day 3)
Beschreibung

Pain intensity (Day 3)

Datentyp

integer

Alias
UMLS CUI [1]
C1320357
If ongoing after Day 3 - Date of last day of symptom
Beschreibung

If ongoing after Day 3 - Date of last day of symptom

Datentyp

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
Solicited Adverse Experiences - General Symptoms
Beschreibung

Solicited Adverse Experiences - General Symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0159028
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?
Beschreibung

Has the subject experienced any of the following general solicited signs or symptoms during the solicited period ?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
General Symptoms - Only for children from 1 to 5 years old
Beschreibung

General Symptoms - Only for children from 1 to 5 years old

Alias
UMLS CUI-1
C0159028
General symptom
Beschreibung

Please tick box of experienced symptom.

Datentyp

integer

Alias
UMLS CUI [1]
C0159028
Fever (Day 0, 5-9 hours)
Beschreibung

Fever (Day 0, 5-9 hours)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 0, 5-9 hours)
Beschreibung

Temperature (Day 0, 5-9 hours)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)
Beschreibung

Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 0, 5-9 hours)

Datentyp

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
Fever (Day 1)
Beschreibung

Fever (Day 1

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 1)
Beschreibung

Temperature (Day 1)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
Beschreibung

Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)

Datentyp

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
Fever (Day 2)
Beschreibung

Fever (Day 2)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 2)
Beschreibung

Temperature (Day 2)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)
Beschreibung

Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 2)

Datentyp

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
Fever (Day 3)
Beschreibung

Fever (Day 3)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 3)
Beschreibung

Temperature (Day 3)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Relationship
Beschreibung

Relationship

Datentyp

text

Alias
UMLS CUI [1]
C0439849
If ongoing after Day 3 - Date of last day of symptoms
Beschreibung

If ongoing after Day 3 - Date of last day of symptoms

Datentyp

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
General Symptoms - Only for children from 6 to 11 years old
Beschreibung

General Symptoms - Only for children from 6 to 11 years old

Alias
UMLS CUI-1
C0159028
General symptom
Beschreibung

Please tick box of experienced symptom.

Datentyp

integer

Alias
UMLS CUI [1]
C0159028
Fever (Day 0, 5-9 hours)
Beschreibung

Fever (Day 0, 5-9 hours)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 0, 5-9 hours)
Beschreibung

Temperature (Day 0, 5-9 hours)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
Beschreibung

Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)

Datentyp

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
Fever (Day 1)
Beschreibung

Fever (Day 1)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 1)
Beschreibung

Temperature (Day 1)

Datentyp

float

Alias
UMLS CUI [1]
C0005903
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
Beschreibung

Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)

Datentyp

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
Fever (Day 2)
Beschreibung

Fever (Day 2)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 2)
Beschreibung

Temperature (Day 2)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)
Beschreibung

Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 2)

Datentyp

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
Fever (Day 3)
Beschreibung

Fever (Day 3)

Datentyp

integer

Alias
UMLS CUI [1]
C0015967
Temperature (Day 3)
Beschreibung

Temperature (Day 3)

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
Beschreibung

Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)

Datentyp

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
Relationship
Beschreibung

Relationship

Datentyp

text

Alias
UMLS CUI [1]
C0439849
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Ähnliche Modelle

Visit 4 Dose 2 - Laboratory Tests; Baseline Temperature; Baseline Assessment; Vaccine Administration; Solicited Adverse Experiences - Local Symptoms and General Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Visit
Item
Visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022877 (UMLS CUI-1)
C0430022 (UMLS CUI-2)
Has a blood sample been taken ?
Item
Has a blood sample been taken ?
boolean
C1277698 (UMLS CUI [1])
Item Group
Baseline Temperature
C0005903 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
integer
C0005903 (UMLS CUI [1,1])
C0449687 (UMLS CUI [1,2])
Route
Code List
Route
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)
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])
Item Group
General Symptoms Observed Just Before Injection
C0159028 (UMLS CUI-1)
C1533685 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Irritability/ Fussiness  (1)
CL Item
Drowsiness  (2)
CL Item
Loss of appetite (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
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)
Item
Symptom
integer
C1457887 (UMLS CUI [1])
Symptom
Code List
Symptom
CL Item
Headache  (1)
CL Item
Fatigue  (2)
CL Item
Gastrointestinal symptoms (3)
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
1  (1)
CL Item
2  (2)
CL Item
3 (3)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Has the study vaccine been administered?
Item
Has the study vaccine been administered?
boolean
C2368628 (UMLS CUI [1,1])
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])
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])
If study Vaccine has been administered, record Side/ Site Route
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])
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])
If study vaccine has not been administered according to the protocol, record Site and Route of Administration.
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])
undefined item
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)
Has the Diary Card been returned?
Item
Has the Diary Card been returned?
boolean
C3890583 (UMLS CUI [1,1])
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])
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Local Symptoms (at the injection site)
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [2])
Local Symptoms (at the injection site)
Code List
Local Symptoms (at the injection site)
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])
Item
Pain intensity (Day 0, 5-9 hours)
integer
C1320357 (UMLS CUI [1])
Day 0 - 5-9 hours
Code List
Pain intensity (Day 0, 5-9 hours)
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])
Item
Pain intensity (Day 1)
integer
C1320357 (UMLS CUI [1])
Pain intensity (Day 1)
Code List
Pain intensity (Day 1)
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])
Item
Pain intensity (Day 2)
integer
C1320357 (UMLS CUI [1])
Pain intensity (Day 2)
Code List
Pain intensity (Day 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])
Item
Pain intensity (Day 3)
integer
C1320357 (UMLS CUI [1])
Pain intensity (Day 3)
Code List
Pain intensity (Day 3)
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])
Item Group
Solicited Adverse Experiences - General Symptoms
C0877248 (UMLS CUI-1)
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])
Item Group
General Symptoms - Only for children from 1 to 5 years old
C0159028 (UMLS CUI-1)
Item
General symptom
integer
C0159028 (UMLS CUI [1])
General symptom
Code List
General symptom
CL Item
Fever (1)
CL Item
Irratibility/ Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
Item
Fever (Day 0, 5-9 hours)
integer
C0015967 (UMLS CUI [1])
Fever (Day 0, 5-9 hours)
Code List
Fever (Day 0, 5-9 hours)
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])
Intensity of Irritability/ Fussiness (Day 0, 5-9 hours)
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)
Item
Fever (Day 1)
integer
C0015967 (UMLS CUI [1])
Fever (Day 1
Code List
Fever (Day 1)
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])
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 1)
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)
Item
Fever (Day 2)
integer
C0015967 (UMLS CUI [1])
Fever (Day 2)
Code List
Fever (Day 2)
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])
Intensity of Irritability/ Fussiness, Drowsiness or Loss of Appetite (Day 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)
Item
Fever (Day 3)
integer
C0015967 (UMLS CUI [1])
Fever (Day 3)
Code List
Fever (Day 3)
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])
Item
Relationship
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship
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])
Item Group
General Symptoms - Only for children from 6 to 11 years old
C0159028 (UMLS CUI-1)
Item
General symptom
integer
C0159028 (UMLS CUI [1])
General symptom
Code List
General symptom
CL Item
Fever  (1)
CL Item
Headache  (2)
CL Item
Fatigue  (3)
CL Item
Gastrointestinal symptoms (4)
Item
Fever (Day 0, 5-9 hours)
integer
C0015967 (UMLS CUI [1])
Fever (Day 0, 5-9 hours)
Code List
Fever (Day 0, 5-9 hours)
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])
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 0, 5-9 hours)
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)
Item
Fever (Day 1)
integer
C0015967 (UMLS CUI [1])
Fever (Day 1)
Code List
Fever (Day 1)
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])
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 1)
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)
Item
Fever (Day 2)
integer
C0015967 (UMLS CUI [1])
Fever (Day 2)
Code List
Fever (Day 2)
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])
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 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)
Item
Fever (Day 3)
integer
C0015967 (UMLS CUI [1])
Fever (Day 3)
Code List
Fever (Day 3)
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])
Intensity of Headache, Fatigue or Gastrointestinal symptoms (Day 3)
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)
Item
Relationship
text
C0439849 (UMLS CUI [1])
Relationship
Code List
Relationship
CL Item
Not related  (NR)
CL Item
Unlikely  (UL)
CL Item
Suspected PB=Probable (SU)
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