ID

25913

Description

Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

Versions (2)
  1. 6/26/17 6/26/17 -
  2. 9/26/17 9/26/17 -
Uploaded on

September 26, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)

English

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)

1 forms  
Form information
Description

Form information

Alias
UMLS CUI-1
C1533716
Information
Description

REMINDERS ADVERSE EVENTS Please report adverse events as specified in the Protocol and fill in the Non-Serious Adverse Events section or the Serious Adverse Event (SAE) form, as appropriate. This SAE form must be faxed to GlaxoSmithKline within 24 hours of you becoming aware of these events. MEDICATION Please report medication as specified in the Protocol and fill in the Medication section. Please report concomitant vaccination in the Concomitant Vaccination section. PREGNANCY In case of pregnancy please fill in the Pregnancy Notification form. This form must be faxed to GlaxoSmithKline within 24 hours of you becoming aware of these events. CONTRAINDICATIONS Before any vaccine administration, please review the Contraindications as specified in the Protocol. DIARY CARD Please provide the diary card to the subject.

Data type

text

Alias
UMLS CUI [1]
C1533716
Introductory information read
Description

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION HavrixTM, Engerix B, Twinrix Adult should not be administered to subjects with known hypersensitivity to any component of the vaccine, or to subjects having shown signs of hypersensitivity after previous administration with other vaccines, the administration of HavrixTM, Engerix B, Twinrix Adult should be postponed in subjects suffering from acute severe febrile illness. Note regarding pregnancy and lactation: • Adequate human data on use during pregnancy and adequate animal reproduction studies are not available. However, as with all inactivated viral vaccines one does not expect harm for the foetus. Twinrix Adult should be used during pregnancy only when there is a clear risk of hepatitis A and hepatitis B. Havrix should be used during pregnancy only when clearly needed. Engerix B should be used during pregnancy only when clearly needed, and the possible advantages outweigh the possible risks for the foetus. • Adequate human data on use during lactation and adequate animal reproduction studies are not available. Twinrix Adult should therefore be used with caution in breastfeeding women. Havrix should be used during lactation only when clearly needed. Engerix B: No contra-indication has been established

Data type

boolean

Alias
UMLS CUI [1,1]
C1533716
UMLS CUI [1,2]
C0579004
General medical history / physical examination
Description

General medical history / physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0031809
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
Description

Comorbidity

Data type

text

Alias
UMLS CUI [1]
C0009488
Cutaneous
Description

Cutaneous

Data type

text

Alias
UMLS CUI [1]
C0221912
Cutaneous: diagnosis
Description

Cutaneous: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0037274
UMLS CUI [1,2]
C0011900
Eyes
Description

Eyes

Data type

text

Alias
UMLS CUI [1]
C0015392
Eyes: diagnosis
Description

Eyes: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0011900
Ears-Nose-Throat
Description

Ears-Nose-Throat

Data type

text

Alias
UMLS CUI [1]
C0395797
Ears-Nose-Throat: diagnosis
Description

Ears-Nose-Throat: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0395797
UMLS CUI [1,2]
C0011900
Cardiovascular
Description

Cardiovascular

Data type

text

Alias
UMLS CUI [1]
C0007226
Cardiovascular: diagnosis
Description

Cardiovascular: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0011900
Respiratory
Description

Respiratory

Data type

text

Alias
UMLS CUI [1]
C0035237
Respiratory: diagnosis
Description

Respiratory: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0035204
UMLS CUI [1,2]
C0011900
Gastrointestinal
Description

Gastrointestinal

Data type

text

Alias
UMLS CUI [1]
C0012240
Gastrointestinal: diagnosis
Description

Gastrointestinal: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0011900
Muskuloskeletal
Description

Muskuloskeletal

Data type

text

Alias
UMLS CUI [1]
C0026860
Muskuloskeletal: diagnosis
Description

Muskuloskeletal: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0026857
UMLS CUI [1,2]
C0011900
Neurological
Description

Neurological

Data type

text

Alias
UMLS CUI [1]
C0027763
Neurological: diagnosis
Description

Neurological: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0011900
Genitourinary
Description

Genitourinary

Data type

text

Alias
UMLS CUI [1]
C0042066
Genitourinary: diagnosis
Description

Genitourinary: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0080276
UMLS CUI [1,2]
C0011900
Haematology
Description

Haematology

Data type

text

Alias
UMLS CUI [1]
C0474523
Haematology: diagnosis
Description

Haematology: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0018939
UMLS CUI [1,2]
C0011900
Allergies
Description

Hypersensitivity

Data type

text

Alias
UMLS CUI [1]
C0020517
Allergies: diagnosis
Description

Hypersensitivity: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0011900
Endocrine
Description

Endocrine

Data type

text

Alias
UMLS CUI [1]
C0014130
Endocrine: diagnosis
Description

Endocrine: diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0011900
Other (specify)
Description

Other (specify)

Data type

text

Alias
UMLS CUI [1]
C3845569
Other
Description

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Data type

text

Alias
UMLS CUI [1]
C0005834
Date of blood sample
Description

Collection Date

Data type

date

Alias
UMLS CUI [1]
C1317250
Has a urine sample been taken?
Description

HCG urine pregnancy test

Data type

text

Alias
UMLS CUI [1]
C0430056
Date of pregnancy test
Description

Date of pregnancy test

Data type

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result from pregnancy test
Description

Pregnancy test finding

Data type

text

Alias
UMLS CUI [1]
C0427777
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date of vaccine administration
Description

Date of vaccine administration

Data type

date

Pre-vaccination temperature
Description

Pre-vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Route
Description

Administration Route

Data type

text

Alias
UMLS CUI [1]
C0013153
Vaccacine administration
Description

only one box must be ticked by vaccine

Data type

text

Alias
UMLS CUI [1]
C2368628
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
Description

Twinrix™ Adult: Protocol Administration

Data type

text

Alias
UMLS CUI [1,1]
C0595042
UMLS CUI [1,2]
C0547696
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
Description

Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol

Data type

text

Alias
UMLS CUI [1,1]
C0595042
UMLS CUI [1,2]
C0547696
UMLS CUI [1,3]
C2348235
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
Description

Engerix™ (20 μg) Vaccine: Protocol Administration

Data type

text

Alias
UMLS CUI [1,1]
C0116078
UMLS CUI [1,2]
C0547696
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
Description

Havrix™ (720 EL.U) Vaccine: Protocol Administration

Data type

text

Alias
UMLS CUI [1,1]
C0700881
UMLS CUI [1,2]
C0547696
Why not administered?
Description

Please tick the ONE most appropriate category for non administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348235
Other, please specify (reason for non administration)
Description

Specification of reason for non administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
Please tick who took the decision
Description

IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
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

Unsolicited adverse events

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0042196
Soliticited adverse events - local symptoms
Description

Soliticited adverse events - local symptoms

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
Description

Soliticited adverse events - local symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Local symptoms: Redness
Description

Erythema

Data type

text

Alias
UMLS CUI [1]
C0041834
Local symptoms day 0
Description

Erythema: day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0041834
UMLS CUI [1,2]
C0808070
mm
Local symptoms day 1
Description

Erythema: day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0041834
UMLS CUI [1,2]
C1442449
mm
Local symptoms day 2
Description

Erythema: day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0041834
UMLS CUI [1,2]
C3842676
mm
Local symptoms day 3
Description

Erythema: day 3

Data type

float

Measurement units
  • mm
mm
Ongoing after Day 3
Description

Erythema: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0041834
UMLS CUI [1,2]
C0549178
Date of last day of symptoms (redness)
Description

Erythema: Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0041834
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Local symptoms: swelling
Description

Swelling

Data type

text

Alias
UMLS CUI [1]
C0038999
Local symptoms day 0
Description

Swelling: day 0

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0808070
mm
Local symptoms day 1
Description

Swelling: day 1

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C1442449
mm
Local symptoms day 2
Description

Swelling: day 2

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3842676
mm
Local symptoms day 3
Description

Swelling: Local symptoms day 3

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C3842675
mm
Ongoing after Day 3
Description

Swelling: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0549178
Date of last day of symptoms (swelling)
Description

Swelling: Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Local symptoms: pain
Description

Pain

Data type

text

Alias
UMLS CUI [1]
C0030193
Intensity of pain day 0
Description

Intensity of pain: day 0

Data type

text

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0808070
Intensity of pain day 1
Description

Intensity of pain: day 1

Data type

text

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C1442449
Intensity of pain day 2
Description

Intensity of pain: day 2

Data type

text

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842676
Intensity of pain day 3
Description

Intensity of pain: day 3

Data type

text

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C3842675
Ongoing after Day 3
Description

Pain: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0549178
Date of last day of symptoms (pain)
Description

Pain: Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Solicid adverse events - general symptoms
Description

Solicid adverse events - general symptoms

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

Soliticed adverse events: General Symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0159028
General symptoms: Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Fever: if yes, please specify amount of fever
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Taking temperature
Description

Taking temperature

Data type

text

Alias
UMLS CUI [1]
C0886414
Fever day 0
Description

Fever: day 0

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0808070
°C
Fever not taken day 0
Description

Fever: day 0 Specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C2348235
Fever day 1
Description

Fever: day 1

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C1442449
°C
Fever not taken day 1
Description

Fever: day 1 Specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C1442449
UMLS CUI [1,3]
C2348235
Fever day 2
Description

Fever: day 2

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3842676
°C
Fever not taken day 2
Description

Fever: day 2 Specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3842676
UMLS CUI [1,3]
C2348235
Fever day 3
Description

Fever: day 3

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3842675
°C
Fever not taken day 3
Description

Fever: day 3 Specification

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3842675
UMLS CUI [1,3]
C2348235
Ongoing after Day 3
Description

Fever: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Fever: Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality
Description

Fever: Causality

Data type

boolean

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

Fatigue

Data type

text

Alias
UMLS CUI [1]
C0015672
Intensity fatigue day 0
Description

Fatigue: day 0

Data type

text

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0808070
Intensity fatigue day 1
Description

Fatigue: day 1

Data type

text

Intensity fatigue day 2
Description

Fatigue: day 2

Data type

text

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C3842676
Intensity fatigue day 3
Description

Fatigue: day 3

Data type

text

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

Fatigue: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0549178
Date of last Day of symptoms
Description

Fatigue: Date of last Day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality?
Description

Fatigue: Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0015127
Headache
Description

Headache

Data type

text

Alias
UMLS CUI [1]
C0018681
Intensity headache day 0
Description

Headache: day 0

Data type

text

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0808070
Intensity headache day 1
Description

Headache: day 1

Data type

text

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C1442449
Intensity headache day 2
Description

Headache: day 2

Data type

text

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C3842676
Intensity headache day 3
Description

Headache: day 3

Data type

text

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

Headache: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0549178
Date of last Day of Symptoms
Description

Headache: Date of last Day of Symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality
Description

Headache: Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0018681
UMLS CUI [1,2]
C0015127
Gastrointestinal symptoms
Description

Gastrointestinal symptoms

Data type

text

Alias
UMLS CUI [1]
C0426576
Intensity gastrointestinal symptoms day 0
Description

Gastrointestinal symptoms: day 0

Data type

text

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0808070
Intensity gastrointestinal symptoms day 1
Description

Gastrointestinal symptoms: day 1

Data type

text

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C1442449
Intensity gastrointestinal symptoms day 2
Description

Gastrointestinal symptoms: day 2

Data type

text

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C3842676
Intensity gastrointestinal symptoms day 3
Description

Gastrointestinal symptoms: day 3

Data type

text

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

Gastrointestinal Symptoms: Ongoing after Day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Gastrointestinal Symptoms: Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C1517741
UMLS CUI [1,4]
C1457887
Causality
Description

Gastrointestinal Symptoms: Causality

Data type

boolean

Alias
UMLS CUI [1,1]
C0426576
UMLS CUI [1,2]
C0015127
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Similar models

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 22 Year 15)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Form information
C1533716 (UMLS CUI-1)
Information
Item
Information
text
C1533716 (UMLS CUI [1])
Introductional information
Item
Introductory information read
boolean
C1533716 (UMLS CUI [1,1])
C0579004 (UMLS CUI [1,2])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
text
C0009488 (UMLS CUI [1])
pre-existing conditions
Code List
Are you aware of any pre-existing conditions or or signs and/or symptoms present in the subject prior to the start of the study?
CL Item
No (1)
CL Item
Yes (Please choose appropriate box(es)and give diagnosis (2)
Item
Cutaneous
text
C0221912 (UMLS CUI [1])
Cutaneous
Code List
Cutaneous
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cutaneous: diagnosis
Item
Cutaneous: diagnosis
text
C0037274 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Eyes
text
C0015392 (UMLS CUI [1])
Eyes
Code List
Eyes
CL Item
not appropriate  (1)
CL Item
past (2)
CL Item
current (3)
Eyes: diagnosis
Item
Eyes: diagnosis
text
C0015397 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Ears-Nose-Throat
text
C0395797 (UMLS CUI [1])
Ears-Nose-Throat
Code List
Ears-Nose-Throat
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Ears-Nose-Throat: diagnosis
Item
Ears-Nose-Throat: diagnosis
text
C0395797 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Cardiovascular
text
C0007226 (UMLS CUI [1])
Cardiovascular
Code List
Cardiovascular
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Cardiovascular: diagnosis
Item
Cardiovascular: diagnosis
text
C0007222 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Respiratory
text
C0035237 (UMLS CUI [1])
Respiratory
Code List
Respiratory
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Respiratory: diagnosis
Item
Respiratory: diagnosis
text
C0035204 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Gastrointestinal
text
C0012240 (UMLS CUI [1])
Gastrointestinal
Code List
Gastrointestinal
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Gastrointestinal: diagnosis
Item
Gastrointestinal: diagnosis
text
C0017178 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Muskuloskeletal
text
C0026860 (UMLS CUI [1])
Muskuloskeletal
Code List
Muskuloskeletal
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Muskuloskeletal: diagnosis
Item
Muskuloskeletal: diagnosis
text
C0026857 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Neurological
text
C0027763 (UMLS CUI [1])
Neurological
Code List
Neurological
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Neurological: diagnosis
Item
Neurological: diagnosis
text
C0027765 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Genitourinary
text
C0042066 (UMLS CUI [1])
Genitourinary
Code List
Genitourinary
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Genitourinary: diagnosis
Item
Genitourinary: diagnosis
text
C0080276 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Haematology
text
C0474523 (UMLS CUI [1])
Haematology
Code List
Haematology
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Haematology: diagnosis
Item
Haematology: diagnosis
text
C0018939 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Allergies
text
C0020517 (UMLS CUI [1])
Allergies
Code List
Allergies
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Hypersensitivity: diagnosis
Item
Allergies: diagnosis
text
C0020517 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Item
Endocrine
text
C0014130 (UMLS CUI [1])
Endocrine
Code List
Endocrine
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Endocrine: diagnosis
Item
Endocrine: diagnosis
text
C0014130 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
Other (specify)
Item
Other (specify)
text
C3845569 (UMLS CUI [1])
Item
Other
text
C0205394 (UMLS CUI [1])
Other
Code List
Other
CL Item
not appropriate (1)
CL Item
past (2)
CL Item
current (3)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken?
text
C0005834 (UMLS CUI [1])
Blood sample
Code List
Has a blood sample been taken?
CL Item
yes (please answer the following question if different from visit date) (1)
CL Item
no (2)
Collection Date
Item
Date of blood sample
date
C1317250 (UMLS CUI [1])
Item
Has a urine sample been taken?
text
C0430056 (UMLS CUI [1])
HCG urine pregnancy test
Code List
Has a urine sample been taken?
CL Item
yes (please answer the following question of different from visit date) (1)
CL Item
no (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result from pregnancy test
text
C0427777 (UMLS CUI [1])
Result from pregnancy test
Code List
Result from pregnancy test
CL Item
negative (1)
CL Item
positive (2)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date of vaccine administration
date
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0013153 (UMLS CUI [1])
Route
Code List
Route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Item
Vaccacine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccacine administration
CL Item
Twinrix™ Adult (720/20) Vaccine (1)
CL Item
Twinrix™ Adult (720/20) Vaccine: Not administered -> Please complete following page (2)
CL Item
Engerix™ (20 μg) Vaccine (3)
CL Item
Engerix™ (20 μg) Vaccine: Not administered -> Please complete following page (4)
CL Item
Havrix™ (720 EL.U)Vaccine (5)
CL Item
Havrix™ (720 EL.U)Vaccine: Not administered -> Please complete following page (6)
Item
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
Code List
Twinrix™ Adult (720/20) Vaccine: Has the study vaccine been administered according to the Protocol?
CL Item
Yes (1)
CL Item
No (Please tick all Items that apply) (2)
Item
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
text
C0595042 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
Code List
Twinrix™ Adult (720/20) Vaccine: specification of not administered according to the protocol
CL Item
Side: left (1)
CL Item
Side: right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock  (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
text
C0116078 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
Code List
Engerix™ (20 μg) Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
text
C0700881 (UMLS CUI [1,1])
C0547696 (UMLS CUI [1,2])
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
Code List
Havrix™ (720 EL.U)Vaccine: specification of not administered according to the protocol
CL Item
Side: Left (1)
CL Item
Side: Right (2)
CL Item
Site: Deltoid (3)
CL Item
Site: Thigh (4)
CL Item
Site: Buttock (5)
CL Item
Route: I.M. (6)
CL Item
Route: S.C. (7)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Vaccacine administration (continued)
Code List
Why not administered?
CL Item
Serious adverse event (complete Serious Adverse Event form) (1)
CL Item
Non-serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other (3)
Specification of reason for non administration
Item
Other, please specify (reason for non administration)
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Who took the decision?
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Subject (2)
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
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form. (4)
Item Group
Soliticited adverse events - local symptoms
C0877248 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Item
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Soliticited adverse events - local symptoms
Code List
Has the subject experienced any of the following sings/symptoms at the administration site during the solicited period?
CL Item
Information available (1)
CL Item
No Vaccine administered  (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Item
Local symptoms: Redness
text
C0041834 (UMLS CUI [1])
Local symptoms day 0
Code List
Local symptoms: Redness
CL Item
No (1)
CL Item
Size (please fill in next item) (2)
Erythema: day 0
Item
Local symptoms day 0
float
C0041834 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Erythema: day 1
Item
Local symptoms day 1
float
C0041834 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Erythema: day 2
Item
Local symptoms day 2
float
C0041834 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Erythema: day 3
Item
Local symptoms day 3
float
Erythema: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0041834 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Erythema: Date of last day of symptoms
Item
Date of last day of symptoms (redness)
date
C0041834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Local symptoms: swelling
text
C0038999 (UMLS CUI [1])
Local symptoms: swelling
Code List
Local symptoms: swelling
CL Item
No (1)
CL Item
Yes (please fill in the next item) (2)
Swelling: day 0
Item
Local symptoms day 0
float
C0038999 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Swelling: day 1
Item
Local symptoms day 1
float
C0038999 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Swelling: day 2
Item
Local symptoms day 2
float
C0038999 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Swelling: Local symptoms day 3
Item
Local symptoms day 3
float
C0038999 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Swelling: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0038999 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Swelling: Date of last day of symptoms
Item
Date of last day of symptoms (swelling)
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item
Local symptoms: pain
text
C0030193 (UMLS CUI [1])
Local symptoms: pain
Code List
Local symptoms: pain
CL Item
No (1)
CL Item
Yes, intensity: (please fill in next item) (2)
Item
Intensity of pain day 0
text
C1320357 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Intensity of pain day 0
Code List
Intensity of pain day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 1
text
C1320357 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity of pain day 1
Code List
Intensity of pain day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 2
text
C1320357 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity of pain day 2
Code List
Intensity of pain day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity of pain day 3
text
C1320357 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity of pain day 3
Code List
Intensity of pain day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Pain: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C1320357 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Pain: Date of last day of symptoms
Item
Date of last day of symptoms (pain)
date
C1320357 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Item Group
Solicid adverse events - general symptoms
C0877248 (UMLS CUI-1)
C0159028 (UMLS CUI-2)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
C0877248 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Soliticed adverse events
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (4)
Fever
Item
General symptoms: Fever
boolean
C0015967 (UMLS CUI [1])
Body Temperature
Item
Fever: if yes, please specify amount of fever
float
C0005903 (UMLS CUI [1])
Item
Taking temperature
text
C0886414 (UMLS CUI [1])
Taking temperature
Code List
Taking temperature
CL Item
Axilary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
Fever: day 0
Item
Fever day 0
float
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Fever: day 0 Specification
Item
Fever not taken day 0
boolean
C0015967 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 1
Item
Fever day 1
float
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Fever: day 1 Specification
Item
Fever not taken day 1
boolean
C0015967 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 2
Item
Fever day 2
float
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Fever: day 2 Specification
Item
Fever not taken day 2
boolean
C0015967 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: day 3
Item
Fever day 3
float
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Fever: day 3 Specification
Item
Fever not taken day 3
boolean
C0015967 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Fever: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015967 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Fever: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0015967 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fever: Causality
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Fatigue
text
C0015672 (UMLS CUI [1])
Fatigue
Code List
Fatigue
CL Item
No (1)
CL Item
Yes, please fill in next question (2)
Item
Intensity fatigue day 0
text
C0015672 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Intensity fatigue day 0
Code List
Intensity fatigue day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity fatigue day 1
text
Intensity fatigue day 1
Code List
Intensity fatigue day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity fatigue day 2
text
C0015672 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity fatigue day 2
Code List
Intensity fatigue day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity fatigue day 3
text
C0015672 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity fatigue day 3
Code List
Intensity fatigue day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Fatigue: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0015672 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Fatigue: Date of last Day of symptoms
Item
Date of last Day of symptoms
date
C0015672 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Fatigue: Causality
Item
Causality?
boolean
C0015672 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Headache
text
C0018681 (UMLS CUI [1])
Headache
Code List
Headache
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity headache day 0
text
C0018681 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Intensity headache day 0
Code List
Intensity headache day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 1
text
C0018681 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity headache day 1
Code List
Intensity headache day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 2
text
C0018681 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity headache day 2
Code List
Intensity headache day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity headache day 3
text
C0018681 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity headache day 3
Code List
Intensity headache day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Headache: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0018681 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Headache: Date of last Day of Symptoms
Item
Date of last Day of Symptoms
date
C0018681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Headache: Causality
Item
Causality
boolean
C0018681 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Item
Gastrointestinal symptoms
text
C0426576 (UMLS CUI [1])
Gastrointestinal symptoms
Code List
Gastrointestinal symptoms
CL Item
No (1)
CL Item
Yes, intensity: please fill in the next items (2)
Item
Intensity gastrointestinal symptoms day 0
text
C0426576 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Intensity gastrointestinal symptoms day 0
Code List
Intensity gastrointestinal symptoms day 0
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 1
text
C0426576 (UMLS CUI [1,1])
C1442449 (UMLS CUI [1,2])
Intensity gastrointestinal symptoms day 1
Code List
Intensity gastrointestinal symptoms day 1
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 2
text
C0426576 (UMLS CUI [1,1])
C3842676 (UMLS CUI [1,2])
Intensity gastrointestinal symptoms day 2
Code List
Intensity gastrointestinal symptoms day 2
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Item
Intensity gastrointestinal symptoms day 3
text
C0426576 (UMLS CUI [1,1])
C3842675 (UMLS CUI [1,2])
Intensity gastrointestinal symptoms day 3
Code List
Intensity gastrointestinal symptoms day 3
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
Gastrointestinal Symptoms: Ongoing after Day 3
Item
Ongoing after Day 3
boolean
C0426576 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Gastrointestinal Symptoms: Date of last day of symptoms
Item
Date of last day of symptoms
date
C0426576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,4])
Gastrointestinal Symptoms: Causality
Item
Causality
boolean
C0426576 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
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