ID

26588

Description

Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

Keywords

Versions (3)
  1. 10/17/17 10/17/17 -
  2. 10/20/17 10/20/17 -
  3. 10/20/17 10/20/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 20, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Additional Vaccination Year 6

English

Additional Vaccination Year 6

1 forms  
Long Term Follow up Visit 9
Description

Long Term Follow up Visit 9

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0940824
Center
Description

Study site identifier

Data type

text

Alias
UMLS CUI [1]
C2826692
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Treatment Number
Description

Treatment Number

Data type

text

Alias
UMLS CUI [1]
C1522541
Study Continuation
Description

Study Continuation

Alias
UMLS CUI-1
C0805733
Did the subject come at visit 9?
Description

If Yes, please complete next pages, if No, answer the questions below

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Description

reason for study discontinuation

Data type

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Please specify SAE Number
Description

SAE Number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If other please specify
Description

(e.g.: consent withdrawal, Protocol violation, ...)

Data type

text

Alias
UMLS CUI [1]
C3845569
Please tick who took the decision
Description

Decision of study subject discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Sample Collection Date
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C1302413
Has a urine sample been taken?
Description

HCG urine pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0430056
Sample collection Date
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C1302413
Pregnancy test result
Description

Pregnancy test result

Data type

integer

Alias
UMLS CUI [1]
C0427777
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date of vaccination
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Pre-Vaccination temperature
Description

Body Temperature pre-vaccination

Data type

integer

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
Route
Description

Temperature Measurement site

Data type

text

Alias
UMLS CUI [1]
C0489453
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Wrong vial number
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
Has the study vaccine been administered according to the Protocol?
Description

Has the study vaccine been administered according to the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Site
Description

Please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
Route
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Wrong vial number
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
Has the study vaccine been administered according to the Protocol?
Description

Has the study vaccine been administered according to the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Site
Description

Please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
Route
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Vaccine Administration
Description

Vaccine Administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Wrong vial number
Description

Wrong vial number

Data type

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
Has the study vaccine been administered according to the Protocol?
Description

Has the study vaccine been administered according to the Protocol?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Side
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
Site
Description

Please tick all items that apply

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C2368628
Route
Description

Please tick all items that apply

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Comments
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Why not administered? Please tick the ONE most appropriate category for non administration
Description

Vaccine Administration reason not done

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1272696
Please specify SAE Number
Description

SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Please specify unsolicited AE number
Description

unsolicited AE number

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Please specify solicited AE code
Description

solicited AE code

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1521902
If other please specify
Description

(e.g.: consent withdrawal, Protocol violation, ...)

Data type

text

Alias
UMLS CUI [1]
C3845569
Please tick who took the decision
Description

Decision of discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
Unsolicited Adverse Events
Description

Unsolicited Adverse Events

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
Description

If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Solicited Adverse Events- Local
Description

Solicited Adverse Events- Local

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0853813
UMLS CUI-3
C0042210
Solicited Adverse Events - local symptoms
Description

ONLY FOR SUBJECTS RECEIVING AN ADDITIONAL VACCINATION

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0853813
UMLS CUI [1,3]
C0042210
Local Symptoms - Redness
Description

Local Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
Local Symptoms - Redness Day 0
Description

Local Symptoms

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
mm
Local Symptoms - Redness Day 1
Description

Local Symptoms

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
mm
Local Symptoms - Redness Day 2
Description

Local Symptoms

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
mm
Local Symptoms - Redness Day 3
Description

Local Symptoms

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
mm
Local Symptoms - Redness ongoing after Day 3?
Description

Local Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Local Symptoms - Swelling
Description

Local Symptoms - Swelling

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
Local Symptoms - Swelling Day 0
Description

Local Symptoms - Swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
mm
Local Symptoms - Swelling Day 1
Description

Local Symptoms - Swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
mm
Local Symptoms - Swelling Day 2
Description

Local Symptoms - Swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
mm
Local Symptoms - Swelling Day 3
Description

Local Symptoms - Swelling

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
mm
Local Symptoms - Swelling ongoing after Day 3?
Description

Local Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0853619
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Local Symptoms - Pain
Description

Local Symptoms - Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms - Pain Intensity Day 0
Description

Local Symptoms - Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms - Pain Intensity Day 1
Description

Local Symptoms - Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms - Pain Intensity Day 2
Description

Local Symptoms - Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms - Pain Intensity Day 3
Description

Local Symptoms - Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local Symptoms - Pain ongoing after Day 3?
Description

Local Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0205276
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Solicited Adverse Events- General Symptoms
Description

Solicited Adverse Events- General Symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
Description

ONLY FOR SUBJECTS RECEIVING AN ADDITIONAL VACCINATION ; If any of these adverse events are serious according to Protocol definition, please report event to GSK monitor by telephone or fax within 24 hours (see Protocol) and complete the Serious Adverse Event form.

Data type

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0877248
General Symptoms - Fever
Description

General Symptoms - Fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C1556354
If Fever is yes, measurement route
Description

Body temperature measurement site

Data type

text

Alias
UMLS CUI [1]
C0489453
Body temperature Day 0
Description

Body temperature Day 0

Data type

float

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C2826301
Body temperature Day 0 not taken
Description

Body temperature Day 0 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C2826301
UMLS CUI [1,2]
C0437722
Body temperature Day 1
Description

Body temperature Day 1

Data type

float

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1442449
Body temperature Day 1 not taken
Description

Body temperature Day 1 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C1442449
UMLS CUI [1,2]
C0437722
Body temperature Day 2
Description

Body temperature Day 2

Data type

float

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842676
Body temperature Day 2 not taken
Description

Body temperature Day 2 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842676
UMLS CUI [1,2]
C0437722
Body temperature Day 3
Description

Body temperature Day 3

Data type

float

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C3842675
Body temperature Day 3 not taken
Description

Body temperature Day 3 not taken

Data type

boolean

Alias
UMLS CUI [1,1]
C3842675
UMLS CUI [1,2]
C0437722
Fever ongoing after Day 3
Description

Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C2826663
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

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

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
General Symptoms - Fatigue
Description

General Symptoms - Fatigue

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C1556354
Symptom intensity - Fatigue Day 0
Description

Symptom intensity - Fatigue Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Symptom intensity - Fatigue Day 1
Description

Symptom intensity - Fatigue Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Symptom intensity - Fatigue Day 2
Description

Symptom intensity - Fatigue Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Symptom intensity - Fatigue Day 3
Description

Symptom intensity - Fatigue Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842675
Fatigue Ongoing after Day 3
Description

Fatigue: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C2826663
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

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

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
General Symptoms - Headache
Description

General Symptoms - Headache

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C1556354
Symptom intensity - Headache Day 0
Description

Symptom intensity - Headache Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Symptom intensity - Headache Day 1
Description

Symptom intensity - Headache Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Symptom intensity - Headache Day 2
Description

Symptom intensity - Headache Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Symptom intensity - Headache Day 3
Description

Symptom intensity - Headache Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842675
Headache Ongoing after Day 3
Description

Headache: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C2826663
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

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

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
Gastrointestinal Symptoms
Description

General Symptoms - Gastrointestinal

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C1556354
Symptom intensity - Gastrointestinal symptoms Day 0
Description

Symptom intensity - Gastrointestinal symptoms Day 0

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C2826301
Symptom intensity - Gastrointestinal symptoms Day 1
Description

Symptom intensity - Gastrointestinal symptoms Day 1

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C1442449
Symptom intensity - Gastrointestinal symptoms Day 2
Description

Symptom intensity - Gastrointestinal symptoms Day 2

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842676
Symptom intensity - Gastrointestinal symptoms Day 3
Description

Symptom intensity - Gastrointestinal symptoms Day 3

Data type

integer

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0518690
UMLS CUI [1,3]
C3842675
Gastrointestinal symptoms Ongoing after Day 3
Description

Gastrointestinal symptoms: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C2826663
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

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

Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0015967
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Similar models

Additional Vaccination Year 6

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Long Term Follow up Visit 9
C0042196 (UMLS CUI-1)
C0940824 (UMLS CUI-2)
Study site identifier
Item
Center
text
C2826692 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
text
C1522541 (UMLS CUI [1])
Item Group
Study Continuation
C0805733 (UMLS CUI-1)
Did the subject come at visit 9?
Item
Did the subject come at visit 9?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Gender
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Other please specify (2)
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Race
Code List
Please specify SAE Number
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Decision of study subject discontinuation
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Subject (S)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1])
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI [1])
Item
Has a urine sample been taken?
integer
C0430056 (UMLS CUI [1])
HCG urine pregnancy test
Code List
Has a urine sample been taken?
CL Item
yes  (1)
CL Item
no (2)
CL Item
NA (not of childbearing potential or male) (3)
Sample collection Date
Item
Sample collection Date
date
C1302413 (UMLS CUI [1])
Item
Pregnancy test result
integer
C0427777 (UMLS CUI [1])
Pregnancy test result
Code List
Pregnancy test result
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Vaccination Date
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Pre-Vaccination temperature
integer
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Hepatitis vaccines
Code List
Pre-Vaccination temperature
Item
Route
text
C0489453 (UMLS CUI [1])
Temperature Measurement site
Code List
Route
CL Item
Axillary (A)
CL Item
Oral (O)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Hepatitis A and/or Hepatitis B immunoglobulins
Code List
Vaccine Administration
CL Item
Twinrix Adult (720/20) Vaccine (S)
CL Item
Replacement vial  (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Vaccine administration side
Code List
Side
CL Item
Left (L)
CL Item
Right (R)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Vaccine administration site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
Route
CL Item
I.M (im)
CL Item
S.C (sc)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Hepatitis A and/or Hepatitis B immunoglobulins
Code List
Vaccine Administration
CL Item
Engerix (20) Vaccine (S)
CL Item
Replacement vial  (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Vaccine administration side
Code List
Side
CL Item
Left (L)
CL Item
Right (R)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Vaccine administration site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
Route
CL Item
I.M (im)
CL Item
S.C (sc)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Hepatitis A and/or Hepatitis B immunoglobulins
Code List
Vaccine Administration
CL Item
Havrix (720 EL.U) Vaccine (S)
CL Item
Replacement vial  (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (Please complete following page) (N)
Wrong vial number
Item
Wrong vial number
integer
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Vaccine administration side
Code List
Side
CL Item
Left (L)
CL Item
Right (R)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Vaccine administration site
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Vaccine administration route
Code List
Route
CL Item
I.M (im)
CL Item
S.C (sc)
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Why not administered? Please tick the ONE most appropriate category for non administration
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Vaccine Administration reason not done
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) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (OTH)
SAE number
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
unsolicited AE number
Item
Please specify unsolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
solicited AE code
Item
Please specify solicited AE code
integer
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Decision of study subject discontinuation
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Subject (S)
Item Group
Unsolicited Adverse Events
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
text
C0877248 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Unsolicited Adverse Events
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
CL Item
No (N)
CL Item
No vaccine administered  (NA)
CL Item
Information not available (U)
CL Item
Yes, Fill in the Non-Serious Adverse Event section or Serious Adverse Event report as necessary. (Y)
Item Group
Solicited Adverse Events- Local
C0877248 (UMLS CUI-1)
C0853813 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Solicited Adverse Events - local symptoms
text
C0877248 (UMLS CUI [1,1])
C0853813 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Solicited Adverse Events - local symptoms
Code List
Solicited Adverse Events - local symptoms
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
Local Symptoms
Item
Local Symptoms - Redness
boolean
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 0
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 1
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 2
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness Day 3
integer
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Local Symptoms
Item
Local Symptoms - Redness ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling
boolean
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 0
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 1
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 2
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms - Swelling
Item
Local Symptoms - Swelling Day 3
integer
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
Local Symptoms
Item
Local Symptoms - Swelling ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0853619 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local Symptoms - Pain
Item
Local Symptoms - Pain
boolean
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Item
Local Symptoms - Pain Intensity Day 0
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Symptom intensity
Code List
Local Symptoms - Pain Intensity Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 1
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Symptom intensity
Code List
Local Symptoms - Pain Intensity Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 2
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Symptom intensity
Code List
Local Symptoms - Pain Intensity Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Local Symptoms - Pain Intensity Day 3
integer
C0030193 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Symptom intensity
Code List
Local Symptoms - Pain Intensity Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Local Symptoms
Item
Local Symptoms - Pain ongoing after Day 3?
boolean
C1457887 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited Adverse Events- General Symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C1457887 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Solicited Adverse Events - local symptoms
Code List
Solicited Adverse Events- Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
General Symptoms - Fever
Item
General Symptoms - Fever
boolean
C0015967 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
If Fever is yes, measurement route
text
C0489453 (UMLS CUI [1])
Temperature Measurement site
Code List
If Fever is yes, measurement route
CL Item
Axillary (A)
CL Item
Oral (O)
Body temperature Day 0
Item
Body temperature Day 0
float
C0005903 (UMLS CUI [1,1])
C2826301 (UMLS CUI [1,2])
Body temperature Day 0 not taken
Item
Body temperature Day 0 not taken
boolean
C2826301 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 1
Item
Body temperature Day 1
float
C0005903 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Body temperature Day 1 not taken
Item
Body temperature Day 1 not taken
boolean
C1442449 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 2
Item
Body temperature Day 2
float
C0005903 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Body temperature Day 2 not taken
Item
Body temperature Day 2 not taken
boolean
C3842676 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Body temperature Day 3
Item
Body temperature Day 3
float
C0005903 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Body temperature Day 3 not taken
Item
Body temperature Day 3 not taken
boolean
C3842675 (UMLS CUI [1,1])
C0437722 (UMLS CUI [1,2])
Ongoing after Day 3
Item
Fever ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Fatigue
Item
General Symptoms - Fatigue
boolean
C0015672 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Fatigue Day 0
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Fatigue Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 1
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Fatigue Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 2
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Fatigue Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Fatigue Day 3
integer
C0015672 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Fatigue Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Fatigue: Ongoing after Day 3
Item
Fatigue Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Headache
Item
General Symptoms - Headache
boolean
C0018681 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Headache Day 0
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Headache Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 1
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Headache Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 2
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Headache Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Headache Day 3
integer
C0018681 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Headache Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Headache: Ongoing after Day 3
Item
Headache Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
General Symptoms - Gastrointestinal
Item
Gastrointestinal Symptoms
boolean
C0426576 (UMLS CUI [1,1])
C1556354 (UMLS CUI [1,2])
Item
Symptom intensity - Gastrointestinal symptoms Day 0
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Gastrointestinal symptoms Day 0
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 1
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Gastrointestinal symptoms Day 1
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 2
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Gastrointestinal symptoms Day 2
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
Symptom intensity - Gastrointestinal symptoms Day 3
integer
C0426576 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Symptom intensity
Code List
Symptom intensity - Gastrointestinal symptoms Day 3
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Gastrointestinal symptoms: Ongoing after Day 3
Item
Gastrointestinal symptoms Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C2826663 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
Causality
Item
Causality?
boolean
C0015127 (UMLS CUI [1,1])
C0015967 (UMLS CUI [1,2])
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