ID

34690

Description

Study ID:103812 & 104727 Clinical Study ID:103812 & 104727 Study Title: Study to assess safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw-HBV/Hib when administered at 15 to 18 months of age and of a dose of Mencevax ACWY vaccine. Patient Level Data:N/A Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (1)
  1. 1/23/19 1/23/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Safety and reactogenicity of booster dose of either an investigational vaccination regimen or DTPw HBVHib 103812 & 104727

English

104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms

1 forms  
Local Symptoms
Description

Local Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Day 0 = date of vaccination
Description

Date of vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Local symptoms
Description

Local symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness/ Swelling - Size Day 0
Description

Redness/ Swelling - Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 0
Description

Pain - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 1
Description

Redness/ Swelling - Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 1
Description

Pain - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Description

Redness/ Swelling - Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 2
Description

Pain - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Description

Redness/ Swelling - Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 3
Description

Pain - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
Medically attended Visit?
Description

Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
DTPw/HBV/Hib Vaccine
Description

DTPw/HBV/Hib Vaccine

Alias
UMLS CUI-1
C0042210
Vaccination side
Description

Vaccination side

Data type

text

Alias
UMLS CUI [1]
C0441987
Vaccination site
Description

Vaccination site

Data type

text

Alias
UMLS CUI [1]
C1116171
Day 0 = date of vaccination
Description

Date of vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
DTPw/HBV/Hib Vaccine - Local Symptoms
Description

DTPw/HBV/Hib Vaccine - Local Symptoms

Alias
UMLS CUI-1
C0042210
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local symptoms
Description

Local symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness / Swelling - Size Day 0
Description

Redness / Swelling - Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 0
Description

Pain - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness / Swelling - Size Day 1
Description

Redness / Swelling - Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 1
Description

Pain - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Description

Redness/ Swelling - Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 2
Description

Pain - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Description

Redness/ Swelling - Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 3
Description

Pain - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
Medically attended Visit?
Description

Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Meningitec Vaccine
Description

Meningitec Vaccine

Alias
UMLS CUI-1
C0700144
Vaccination side
Description

Vaccination side

Data type

text

Alias
UMLS CUI [1]
C0441987
Vaccination site
Description

Vaccination site

Data type

text

Alias
UMLS CUI [1]
C1116171
Day 0 = date of vaccination
Description

Date of vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Meningitec Vaccine - Local symptoms
Description

Meningitec Vaccine - Local symptoms

Alias
UMLS CUI-1
C0700144
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Local symptoms
Description

Local symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
Redness/ Swelling - Size Day 0
Description

Redness/ Swelling - Size Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 0
Description

Pain - Intensity Day 0

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness / Swelling - Size Day 1
Description

Redness / Swelling - Size Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 1
Description

Pain - Intensity Day 1

Data type

integer

Alias
UMLS CUI [1]
C1320357
UMLS CUI [2]
C0011008
Redness/ Swelling - Size Day 2
Description

Redness/ Swelling - Size Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 2
Description

Pain - Intensity Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Redness/ Swelling - Size Day 3
Description

Redness/ Swelling - Size Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0456389
UMLS CUI [3]
C0011008
mm
Pain - Intensity Day 3
Description

Pain - Intensity Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
Ongoing after day 3?
Description

Ongoing after day 3?

Data type

boolean

Alias
UMLS CUI [1]
C0549178
Date of last Day of Symptoms
Description

Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1457887
Medically attended Visit?
Description

Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
Other local Symptoms
Description

Other local Symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Description - please specify side(s) and site(s)
Description

Description - please specify side(s) and site(s)

Data type

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C2348235
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C2348235
Intensity
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
Start date
Description

Start date

Data type

date

Alias
UMLS CUI [1]
C0808070
End date, if not continuing.
Description

End date, if not continuing.

Data type

date

Alias
UMLS CUI [1]
C0806020
If continuing check box
Description

If continuing check box

Data type

integer

Alias
UMLS CUI [1]
C0549178
Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
General Symptoms
Description

General Symptoms

Alias
UMLS CUI-1
C0159028
Temperature (axillary) Day 0
Description

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 1 Evening
Description

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 2 Evening
Description

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature (axillary) - Day 3 Evening
Description

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value of the day.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0011008
°C
Temperature - Ongoing after Day 3?
Description

Temperature - Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0549178
Date of last Day of Temperature
Description

Date of last Day of Temperature

Data type

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0806020
Temperature - Medically attended visit?
Description

Temperature - Medically attended visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
UMLS CUI [1,4]
C0005903
Intensity of Irratibility/ Fusiness Day 0
Description

Intensity of Irratibility/ Fusiness Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness - Day 1 Evening
Description

Intensity of Irratibility/ Fusiness - Day 1 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness - Day 2 Evening
Description

Intensity of Irratibility/ Fusiness - Day 2 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Irratibility/ Fusiness - Day 3 Evening
Description

Intensity of Irratibility/ Fusiness - Day 3 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
Description

I.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps)

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C2721683
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Description

Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0518690
UMLS CUI [2,1]
C0438697
UMLS CUI [2,2]
C0449238
Irritability/ Fussiness - Ongoing after Day 3?
Description

Irritability/ Fussiness - Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0549178
Date of last Day of Irritability/ Fussiness
Description

Date of last Day of Irritability/ Fussiness

Data type

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0806020
Irritability/ Fusiness - Medically attended Visit?
Description

Irritability/ Fusiness - Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
Intensity of Drowsiness - Day 0
Description

Intensity of Drowsiness - Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness - Day 1 Evening
Description

Intensity of Drowsiness - Day 1 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness - Day 2 Evening
Description

Intensity of Drowsiness - Day 2 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Drowsiness - Day 3 Evening
Description

Intensity of Drowsiness - Day 3 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Drowsiness - Ongoing after Day 3?
Description

Drowsiness - Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0549178
Date of last Day of Drowsiness
Description

Date of last Day of Drowsiness

Data type

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0806020
Drowsiness - Medically attended Visit?
Description

Drowsiness - Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Intensity of Loss of appetite - Day 0
Description

Intensity of Loss of appetite - Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite - Day 1 Evening
Description

Intensity of Loss of appetite - Day 1 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite - Day 2 Evening
Description

Intensity of Loss of appetite - Day 2 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Intensity of Loss of appetite - Day 3 Evening
Description

Intensity of Loss of appetite - Day 3 Evening

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0518690
UMLS CUI [2]
C0011008
Loss of appetite - Ongoing after Day 3?
Description

Loss of appetite - Ongoing after Day 3?

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0549178
Date of last Day of Loss of appetite
Description

Date of last Day of Loss of appetite

Data type

text

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0806020
Loss of appetite - Medically attended Visit?
Description

Loss of appetite - Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Day 0 = date of vaccination
Description

Date of vaccination

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Other general symptoms
Description

Other general symptoms

Alias
UMLS CUI-1
C0029625
Description - please give details below
Description

Description - please give details below

Data type

text

Alias
UMLS CUI [1]
C0678257
UMLS CUI [2]
C1522508
Intensity
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0518690
General Symptoms Start date
Description

General Symptoms Start date

Data type

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0808070
General Symptoms End date
Description

Check box if continuous

Data type

date

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0806020
Check box, if general symptoms are continuing.
Description

Check box, if general symptoms are continuing.

Data type

integer

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Medication Trade/ Generic name
Description

Medication Trade/ Generic name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0592502
Reason for medication
Description

Reason for medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392360
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439810
Medication Start date
Description

Medication Start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Medication Stop date
Description

Medication Stop date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box, if continuing
Description

Tick box, if continuing

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Similar models

104727 (DTPW-HBV=HIB-MENAC-TT-016 BST 003 (15-24 months)) - Local symptoms; General Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Local Symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
Redness/ Swelling - Size Day 0
Item
Redness/ Swelling - Size Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 0
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain - Intensity Day 0
CL Item
Absent (0)
CL Item
Minor reaction to touch (1)
CL Item
Cries/ protests on touch (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness/ Swelling - Size Day 1
Item
Redness/ Swelling - Size Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 1
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain - Intensity Day 1
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 2
Item
Redness/ Swelling - Size Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 2 Evening
Code List
Pain - Intensity Day 2
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 3 Evening
Code List
Pain - Intensity Day 3
CL Item
Absent (0)
(Comment:en)
CL Item
Minor reaction to touch (1)
(Comment:en)
CL Item
Cries/ protests on touch (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
DTPw/HBV/Hib Vaccine
C0042210 (UMLS CUI-1)
Item
Vaccination side
text
C0441987 (UMLS CUI [1])
Vaccination side
Code List
Vaccination side
CL Item
Left (L)
CL Item
Right (R)
Item
Vaccination site
text
C1116171 (UMLS CUI [1])
Vaccination site
Code List
Vaccination site
CL Item
Arm (A)
CL Item
Thigh (T)
CL Item
Buttock (B)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
DTPw/HBV/Hib Vaccine - Local Symptoms
C0042210 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness  (1)
CL Item
Swelling  (2)
CL Item
Pain (3)
Redness / Swelling - Size Day 0
Item
Redness / Swelling - Size Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 0
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain - Intensity Day 0
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness / Swelling - Size Day 1
Item
Redness / Swelling - Size Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 1
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 1 Evening
Code List
Pain - Intensity Day 1
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 2
Item
Redness/ Swelling - Size Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 2 Evening
Code List
Pain - Intensity Day 2
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain Intensity Day 3 Evening
Code List
Pain - Intensity Day 3
CL Item
Absent  (0)
(Comment:en)
CL Item
Minor reaction to touch  (1)
(Comment:en)
CL Item
Cries/ protests on touch  (2)
(Comment:en)
CL Item
Cries when limb is moved/ spontaneously painful (3)
(Comment:en)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
Meningitec Vaccine
C0700144 (UMLS CUI-1)
Item
Vaccination side
text
C0441987 (UMLS CUI [1])
Vaccination side
Code List
Vaccination side
CL Item
Left  (L)
CL Item
Right (R)
Item
Vaccination site
text
C1116171 (UMLS CUI [1])
Vaccination site
Code List
Vaccination site
CL Item
Arm  (A)
CL Item
Thigh  (T)
CL Item
Buttock (B)
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Meningitec Vaccine - Local symptoms
C0700144 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Local symptoms
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
Local symptoms
Code List
Local symptoms
CL Item
Redness  (1)
CL Item
Swelling  (2)
CL Item
Pain (3)
Redness/ Swelling - Size Day 0
Item
Redness/ Swelling - Size Day 0
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 0
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain Intensity Day 0
Code List
Pain - Intensity Day 0
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness / Swelling - Size Day 1
Item
Redness / Swelling - Size Day 1
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 1
integer
C1320357 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Pain - Intensity Day 1
Code List
Pain - Intensity Day 1
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness/ Swelling - Size Day 2
Item
Redness/ Swelling - Size Day 2
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 2
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain - Intensity Day 2
Code List
Pain - Intensity Day 2
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Redness/ Swelling - Size Day 3
Item
Redness/ Swelling - Size Day 3
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
C0011008 (UMLS CUI [3])
Item
Pain - Intensity Day 3
integer
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pain - Intensity Day 3
Code List
Pain - Intensity Day 3
CL Item
Absent  (0)
CL Item
Minor reaction to touch  (1)
CL Item
Cries/ protests on touch  (2)
CL Item
Cries when limb is moved/ spontaneously painful (3)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
C0549178 (UMLS CUI [1])
Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0806020 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
Other local Symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Description - please specify side(s) and site(s)
Item
Description - please specify side(s) and site(s)
text
C0678257 (UMLS CUI [1])
C0441987 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C2348235 (UMLS CUI [3,2])
Item
Intensity
integer
C0518690 (UMLS CUI [1])
Intensity
Code List
Intensity
CL Item
Mild (An adverse even which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities) (1)
CL Item
Moderate (An adverse event which is sufficiently discomforting to interfere with normal everyday activities) (2)
CL Item
An adverse event which prevents normal, everyday activities [In a young child, such an adverse event would, for example, prevent attendance at school/ kindergarten/ a day- care center and would cause the parents/ guardians to seek medical advice]) (3)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
End date, if not continuing.
Item
End date, if not continuing.
date
C0806020 (UMLS CUI [1])
Item
If continuing check box
integer
C0549178 (UMLS CUI [1])
If continuing check box
Code List
If continuing check box
CL Item
Continuing (1)
Medically attended visit?
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Temperature (axillary) Day 0
Item
Temperature (axillary) Day 0
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) - Day 1 Evening
Item
Temperature (axillary) - Day 1 Evening
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) - Day 2 Evening
Item
Temperature (axillary) - Day 2 Evening
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature (axillary) - Day 3 Evening
Item
Temperature (axillary) - Day 3 Evening
float
C1531924 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Temperature - Ongoing after Day 3?
Item
Temperature - Ongoing after Day 3?
boolean
C0005903 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Temperature
Item
Date of last Day of Temperature
date
C0005903 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Temperature - Medically attended visit?
Item
Temperature - Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,4])
Item
Intensity of Irratibility/ Fusiness Day 0
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 0
Code List
Intensity of Irratibility/ Fusiness Day 0
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness - Day 1 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 1
Code List
Intensity of Irratibility/ Fusiness - Day 1 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness - Day 2 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 2
Code List
Intensity of Irratibility/ Fusiness - Day 2 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Item
Intensity of Irratibility/ Fusiness - Day 3 Evening
integer
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Irratibility/ Fusiness Day 3
Code List
Intensity of Irratibility/ Fusiness - Day 3 Evening
CL Item
Behavior as usual (0)
CL Item
Crying more than usual/ no effect on normal activity (1)
CL Item
Crying more than usual/ interferes with normal activity (2)
CL Item
Crying that cannot be comforted/ prevents normal activity (3)
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying continuous?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2721683 (UMLS CUI [2])
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
Item
Irritability/ Fusiness - In case of intensity 3, was the crying unaltered >= 3 hours?
boolean
C0022107 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0438697 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Irritability/ Fussiness - Ongoing after Day 3?
Item
Irritability/ Fussiness - Ongoing after Day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Irritability/ Fussiness
Item
Date of last Day of Irritability/ Fussiness
date
C0022107 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Irritability/ Fusiness - Medically attended Visit?
Item
Irritability/ Fusiness - Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Intensity of Drowsiness - Day 0
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 0
Code List
Intensity of Drowsiness - Day 0
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness - Day 1 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 1
Code List
Intensity of Drowsiness - Day 1 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness - Day 2 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 2
Code List
Intensity of Drowsiness - Day 2 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Item
Intensity of Drowsiness - Day 3 Evening
integer
C0013144 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Drowsiness Day 3
Code List
Intensity of Drowsiness - Day 3 Evening
CL Item
Behavior as usual (0)
CL Item
Drowsiness easily tolerated (1)
CL Item
Drowsiness that interferes with normal activity (2)
CL Item
Drowsiness that prevents normal activity (3)
Drowsiness - Ongoing after Day 3?
Item
Drowsiness - Ongoing after Day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Drowsiness
Item
Date of last Day of Drowsiness
date
C0013144 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Drowsiness - Medically attended Visit?
Item
Drowsiness - Medically attended Visit?
boolean
C0013144 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Item
Intensity of Loss of appetite - Day 0
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 0
Code List
Intensity of Loss of appetite - Day 0
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite - Day 1 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 1
Code List
Intensity of Loss of appetite - Day 1 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite - Day 2 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 2
Code List
Intensity of Loss of appetite - Day 2 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Item
Intensity of Loss of appetite - Day 3 Evening
integer
C1971624 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Intensity of Loss of appetite Day 3
Code List
Intensity of Loss of appetite - Day 3 Evening
CL Item
Appetite as usual (0)
CL Item
Eating less than usual/ no effect on normal activity (1)
CL Item
Eating less than usual/ interferes with normal activity (2)
CL Item
No eating at all (3)
Loss of appetite - Ongoing after Day 3?
Item
Loss of appetite - Ongoing after Day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Day of Loss of appetite
Item
Date of last Day of Loss of appetite
text
C1971624 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Loss of appetite - Medically attended Visit?
Item
Loss of appetite - Medically attended Visit?
boolean
C1971624 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Date of vaccination
Item
Day 0 = date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
Other general symptoms
C0029625 (UMLS CUI-1)
Description - please give details below
Item
Description - please give details below
text
C0678257 (UMLS CUI [1])
C1522508 (UMLS CUI [2])
Intensity
Item
Intensity
integer
C0518690 (UMLS CUI [1])
General Symptoms Start date
Item
General Symptoms Start date
date
C0159028 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
General Symptoms End date
Item
General Symptoms End date
date
C0159028 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Check box, if general symptoms are continuing.
integer
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Check box, if general symptoms are continuing.
Code List
Check box, if general symptoms are continuing.
CL Item
General Symptoms continuing (1)
Item Group
Medication
C0013227 (UMLS CUI-1)
Medication Trade/ Generic name
Item
Medication Trade/ Generic name
text
C0013227 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Reason for medication
Item
Reason for medication
text
C0013227 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
Medication Start date
Item
Medication Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Medication Stop date
Item
Medication Stop date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Tick box, if continuing
integer
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Tick box, if continuing
Code List
Tick box, if continuing
CL Item
Continuing (1)
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