ID

28999

Description

A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) given as a booster at 18-24 months of age to pre-term children who have received a three-dose primary immunization course with the same vaccine in study 217744/090.

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

GlaxoSmithKline (GSK)

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) Study ID: 101518

English

Visit 1 Vaccine Administration and adverse events

3 forms  
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date (fill in only if different from visit date)
Description

date of administration

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C2368628
Pre-Vaccination temperature: Axillary
Description

Pre-Vaccination temperature

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Vaccine administration (only one box must be ticked by vaccine)
Description

Vaccine administration, used vaccine, Side / Site Route Left Thigh I.M.

Data type

text

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C3661302
Has the study vaccine been administered according to the Protocol?
Description

vaccine administration according to the Protocol

Data type

boolean

Alias
UMLS CUI [1]
C2368628
side of vaccine administration
Description

If you answered the previous question with No, Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
site of vaccine administration
Description

vaccine administration according to the Protocol, site

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
route of vaccine administration
Description

vaccine administration according to the Protocol, route

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Why not administered? Please tick the ONE most appropriate category for non administration :
Description

If the vaccine was not administered, please answer the following question

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1548562
Adverse events and local symptoms
Description

Adverse events and local symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
Description

serious or non-serious unsolicited adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

Solicited adverse events

Data type

integer

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
Redness
Description

Redness

Alias
UMLS CUI-1
C0332575
UMLS CUI-2
C2700396
Redness?
Description

Local symptoms Redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C2700396
Redness ongoing after day 3?
Description

Ongoing redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of redness:
Description

If you answered the previous question with yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit concerning redness

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Medically attended visit: (see protocol for full definition)
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0332575
Redness day and size
Description

Redness day and size

Alias
UMLS CUI-1
C0332575
UMLS CUI-2
C2700396
Redness day
Description

Redness day

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0332575
Size of local redness
Description

Redness size

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Swelling
Description

Swelling

Swelling?
Description

Local symptoms Swelling

Data type

boolean

Alias
UMLS CUI [1]
C0038999
Swelling ongoing after day 3?
Description

Ongoing Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of swelling:
Description

If you answered the previous question with yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit concerning swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0038999
Medically attended visit: (see protocol for full definition)
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0038999
Swelling day and size
Description

Swelling day and size

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C2700396
Swelling Day
Description

Swelling Day

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0038999
Size of local swelling
Description

Size of swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
UMLS CUI [1,3]
C2700396
mm
Pain
Description

Pain

Pain?
Description

Local symptoms Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
Pain ongoing after day 3?
Description

Ongoing pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C2700396
Date of last day of symptoms of pain:
Description

If you answered the previous question with yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Medically attended visit
Description

Medically attended visit concerning pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0030193
Medically attended visit
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0030193
Pain day and intensity
Description

Pain day and intensity

Alias
UMLS CUI-1
C0030193
UMLS CUI-2
C0522510
UMLS CUI-3
C2700396
Pain Day
Description

Pain Day

Data type

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0030193
Pain intensity
Description

Pain intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C2700396
Adverse events and general symptoms
Description

Adverse events and general symptoms

Alias
UMLS CUI-1
C0159028
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

General symptoms

Data type

integer

Alias
UMLS CUI [1]
C0159028
Fever
Description

Fever

Alias
UMLS CUI-1
C0015967
Fever?
Description

General Symptoms Fever

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
UMLS CUI [1,4]
C0015967
Fever ongoing after day 3?
Description

Ongoing fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last day of symptoms of fever
Description

If you answered the previous question with yes, please specify

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0015967
Causality?
Description

Fever causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Medically attended visit
Description

Medically attended visit concerning fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Medically attended visit
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
Fever day and temperature
Description

Fever day and temperature

Alias
UMLS CUI-1
C0015967
UMLS CUI-2
C0439228
Fever temperature axillary
Description

Fever temperature

Data type

integer

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0015967
°C
Fever Day (axillary)
Description

Fever Day

Data type

integer

Alias
UMLS CUI [1]
C0015967
Irritability / Fussiness
Description

Irritability / Fussiness

Alias
UMLS CUI-1
C0022107
Irritability / Fussiness?
Description

General symptoms Irritability / Fussiness

Data type

boolean

Alias
UMLS CUI [1]
C0022107
Irritability / Fussiness ongoing after day 3?
Description

Ongoing Irritability / Fussiness

Data type

boolean

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

Date of last Irritability / Fussiness

Data type

date

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality of Irritability / Fussiness

Data type

boolean

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0015127
Medically attended visit concerning Irritability / Fussiness
Description

Medically attended visit concerning Irritability / Fussiness

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
Medically attended visit concerning Irritability / Fussiness
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0022107
Irritability / Fussiness day and intensity
Description

Irritability / Fussiness day and intensity

Alias
UMLS CUI-1
C0022107
UMLS CUI-2
C0522510
UMLS CUI-3
C0439228
Intensity of Irritability / Fussiness Day
Description

Intensity of Irritability / Fussiness Day

Data type

integer

Alias
UMLS CUI [1]
C0022107
Intensity of Irritability / Fussiness
Description

Intensity of Irritability / Fussiness

Data type

integer

Alias
UMLS CUI [1,1]
C0022107
UMLS CUI [1,2]
C0522510
Drowsiness
Description

Drowsiness

Alias
UMLS CUI-1
C0013144
Drowsiness?
Description

General symptoms Drowsiness

Data type

boolean

Alias
UMLS CUI [1]
C0013144
Drowsiness ongoing after day 3?
Description

Ongoing drowsiness

Data type

boolean

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

Date of last Drowsiness

Data type

date

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality of Drowsiness

Data type

boolean

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0015127
Medically attended visit
Description

Medically attended visit concerning Drowsiness

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0013144
Medically attended visit concerning drowsiness
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0013144
Drowsiness day and intensity
Description

Drowsiness day and intensity

Alias
UMLS CUI-1
C0013144
UMLS CUI-2
C0522510
UMLS CUI-3
C0439228
Drowsiness Day
Description

Drowsiness Day

Data type

integer

Alias
UMLS CUI [1]
C0013144
Drowsiness intensity
Description

Drowsiness intensity

Data type

integer

Alias
UMLS CUI [1,1]
C0013144
UMLS CUI [1,2]
C0522510
Loss of appetite
Description

Loss of appetite

Alias
UMLS CUI-1
C1971624
Loss of appetite?
Description

General symptoms loss of appetite

Data type

boolean

Alias
UMLS CUI [1]
C1971624
Loss of appetite ongoing after day 3?
Description

Ongoing loss of appetite

Data type

boolean

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

Date of last loss of appetite

Data type

date

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0011008
Causality?
Description

Causality of loss of appetite

Data type

boolean

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0015127
Medically attended visit concerning loss of appetite
Description

Medically attended visit concerning loss of appetite

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1971624
Medically attended visit concerning loss of appetite
Description

If you answered the previous question with yes, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1971624
Loss of appetite day and intensity
Description

Loss of appetite day and intensity

Alias
UMLS CUI-1
C1971624
UMLS CUI-2
C0522510
UMLS CUI-3
C0439228
Intensity of loss of appetite day
Description

Intensity of loss of appetite day

Data type

integer

Alias
UMLS CUI [1]
C1971624
Intensity of loss of appetite
Description

Intensity of loss of appetite

Data type

integer

Alias
UMLS CUI [1,1]
C1971624
UMLS CUI [1,2]
C0522510
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Similar models

Visit 1 Vaccine Administration and adverse events

3 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
date of administration
Item
Date (fill in only if different from visit date)
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature: Axillary
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Vaccine administration (only one box must be ticked by vaccine)
text
C0042210 (UMLS CUI [1])
C3661302 (UMLS CUI [2])
Outcome
Code List
Vaccine administration (only one box must be ticked by vaccine)
CL Item
InfanrixTMhexa Vaccine ([S])
CL Item
Replacement vial ([R])
CL Item
Wrong vial number |__|__|__|__|__| ([W])
CL Item
Not administered ([N])
vaccine administration according to the Protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1])
Item
side of vaccine administration
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Adverse event No.3
Code List
side of vaccine administration
CL Item
Left  ([L])
CL Item
Right ([R])
Item
site of vaccine administration
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Adverse event No.4
Code List
site of vaccine administration
CL Item
Deltoid  (1)
CL Item
Thigh  (3)
CL Item
Buttock (6)
Item
route of vaccine administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Occurrence of serious adverse events
Code List
route of vaccine administration
CL Item
I.M.  ([IM])
CL Item
S.C. ([SC])
Item
Why not administered? Please tick the ONE most appropriate category for non administration :
text
C2368628 (UMLS CUI [1,1])
C1548562 (UMLS CUI [1,2])
Elimination criteria
Code List
Why not administered? Please tick the ONE most appropriate category for non administration :
CL Item
Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° : |__|__| ([SAE])
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N°: |__|__| or Solicited AE code : |__|__| ([AEX])
CL Item
Other, please specify: (e.g. consent withdrawal, protocol violation...) ([OTH])
Item Group
Adverse events and local symptoms
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
integer
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
study subject withdrawal
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?
CL Item
Information not available (91)
CL Item
No Vaccine administered (92)
CL Item
No  (0)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form.unsolicited AE N° (Unsol.): |__|__| or solicited AE code :|__|__| (1)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
integer
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Decision holder
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (91)
CL Item
No Vaccine administered (92)
CL Item
No (0)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
Item Group
Redness
C0332575 (UMLS CUI-1)
C2700396 (UMLS CUI-2)
Local symptoms Redness
Item
Redness?
boolean
C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Ongoing redness
Item
Redness ongoing after day 3?
boolean
C0332575 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing redness
Item
Date of last day of symptoms of redness:
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning redness
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Item
Medically attended visit: (see protocol for full definition)
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit: (see protocol for full definition)
CL Item
Hospitalization (HO)
CL Item
Emergency room (ER)
CL Item
Medical personnel (MD)
Item Group
Redness day and size
C0332575 (UMLS CUI-1)
C2700396 (UMLS CUI-2)
Item
Redness day
integer
C0439228 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
Redness day
Code List
Redness day
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
None  (0)
Redness size
Item
Size of local redness
integer
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Swelling
Local symptoms Swelling
Item
Swelling?
boolean
C0038999 (UMLS CUI [1])
Ongoing Swelling
Item
Swelling ongoing after day 3?
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
ongoing swelling
Item
Date of last day of symptoms of swelling:
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning swelling
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Item
Medically attended visit: (see protocol for full definition)
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Organ system
Code List
Medically attended visit: (see protocol for full definition)
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Swelling day and size
C0038999 (UMLS CUI-1)
C2700396 (UMLS CUI-2)
Item
Swelling Day
integer
C0439228 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Swelling Day
Code List
Swelling Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Size of swelling
Item
Size of local swelling
integer
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Pain
Local symptoms Pain
Item
Pain?
boolean
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing pain
Item
Pain ongoing after day 3?
boolean
C0030193 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Ongoing pain
Item
Date of last day of symptoms of pain:
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Medically attended visit concerning pain
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
Medically attended visit
Code List
Medically attended visit
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Pain day and intensity
C0030193 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C2700396 (UMLS CUI-3)
Item
Pain Day
integer
C0439228 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Redness Day
Code List
Pain Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Pain intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Redness day
Code List
Pain intensity
CL Item
Mild (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
CL Item
None  (0)
Item Group
Adverse events and general symptoms
C0159028 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
integer
C0159028 (UMLS CUI [1])
General symptoms
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (91)
CL Item
No vaccine administered (92)
CL Item
No (0)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (1)
Item Group
Fever
C0015967 (UMLS CUI-1)
General Symptoms Fever
Item
Fever?
boolean
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0015967 (UMLS CUI [1,4])
Ongoing fever
Item
Fever ongoing after day 3?
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Last date of fever
Item
Date of last day of symptoms of fever
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Fever causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Medically attended visit concerning fever
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Medically attended visit concerning fever
Code List
Medically attended visit
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Fever day and temperature
C0015967 (UMLS CUI-1)
C0439228 (UMLS CUI-2)
Fever temperature
Item
Fever temperature axillary
integer
C0039476 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Item
Fever Day (axillary)
integer
C0015967 (UMLS CUI [1])
Fever Day
Code List
Fever Day (axillary)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item Group
Irritability / Fussiness
C0022107 (UMLS CUI-1)
General symptoms Irritability / Fussiness
Item
Irritability / Fussiness?
boolean
C0022107 (UMLS CUI [1])
Ongoing Irritability / Fussiness
Item
Irritability / Fussiness ongoing after day 3?
boolean
C0022107 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Irritability / Fussiness
Item
Date of last Irritability / Fussiness
date
C0022107 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of Irritability / Fussiness
Item
Causality?
boolean
C0022107 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning Irritability / Fussiness
Item
Medically attended visit concerning Irritability / Fussiness
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Item
Medically attended visit concerning Irritability / Fussiness
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0022107 (UMLS CUI [1,3])
Medically attended visit concerning Irritability / Fussiness
Code List
Medically attended visit concerning Irritability / Fussiness
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Irritability / Fussiness day and intensity
C0022107 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Item
Intensity of Irritability / Fussiness Day
integer
C0022107 (UMLS CUI [1])
Intensity of Irritability / Fussiness Day
Code List
Intensity of Irritability / Fussiness Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Intensity of Irritability / Fussiness
integer
C0022107 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of Irritability / Fussiness
Code List
Intensity of Irritability / Fussiness
CL Item
None  (0)
CL Item
Mid (1)
CL Item
Moderat  (2)
CL Item
Severe (3)
Item Group
Drowsiness
C0013144 (UMLS CUI-1)
General symptoms Drowsiness
Item
Drowsiness?
boolean
C0013144 (UMLS CUI [1])
Ongoing drowsiness
Item
Drowsiness ongoing after day 3?
boolean
C0013144 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last Drowsiness
Item
Date of last Drowsiness
date
C0013144 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of Drowsiness
Item
Causality?
boolean
C0013144 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning Drowsiness
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Item
Medically attended visit concerning drowsiness
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
Medically attended visit concerning drowsiness
Code List
Medically attended visit concerning drowsiness
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Drowsiness day and intensity
C0013144 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Item
Drowsiness Day
integer
C0013144 (UMLS CUI [1])
Drowsiness Day
Code List
Drowsiness Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Item
Drowsiness intensity
integer
C0013144 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Drowsiness intensity
Code List
Drowsiness intensity
CL Item
None  (0)
CL Item
Mid  (1)
CL Item
Moderat  (2)
CL Item
Severe (3)
Item Group
Loss of appetite
C1971624 (UMLS CUI-1)
General symptoms loss of appetite
Item
Loss of appetite?
boolean
C1971624 (UMLS CUI [1])
Ongoing loss of appetite
Item
Loss of appetite ongoing after day 3?
boolean
C1971624 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last loss of appetite
Item
Date of last loss of appetite
date
C1971624 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Causality of loss of appetite
Item
Causality?
boolean
C1971624 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Medically attended visit concerning loss of appetite
Item
Medically attended visit concerning loss of appetite
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Item
Medically attended visit concerning loss of appetite
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1971624 (UMLS CUI [1,3])
Medically attended visit concerning loss of appetite
Code List
Medically attended visit concerning loss of appetite
CL Item
Hospitalization  (HO)
CL Item
Emergency room  (ER)
CL Item
Medical personnel (MD)
Item Group
Loss of appetite day and intensity
C1971624 (UMLS CUI-1)
C0522510 (UMLS CUI-2)
C0439228 (UMLS CUI-3)
Item
Intensity of loss of appetite day
integer
C1971624 (UMLS CUI [1])
Intensity of loss of appetite day
Code List
Intensity of loss of appetite day
CL Item
day 0 (1)
CL Item
day 1 (2)
CL Item
day 2 (3)
CL Item
day 3 (4)
Item
Intensity of loss of appetite
integer
C1971624 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Intensity of loss of appetite
Code List
Intensity of loss of appetite
CL Item
None  (0)
CL Item
Mild  (1)
CL Item
Moderate  (2)
CL Item
Severe (3)
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