ID

33887

Beskrivning

Study ID:103860/269 Clinical Study ID:103860/269 (HBV-269) Study Title: Phase II study to evaluate the immunogenicity of GSK Biologicals' preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™-B and evaluate safety and reactogenicity of each vaccine when administered intramuscularly according to a 0, 1, 6 month schedule in healthy volunteers Patient Level Data:Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B

Nyckelord

Versioner (1)
  1. 2019-01-05 2019-01-05 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 januari 2019

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of preservative-free Engerix-B and thiomersal-free Engerix-B vaccines compared to Engerix™️-B

Engelsk

Visit 4

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 4
Administration data
Beskrivning

Administration data

Alias
UMLS CUI-1
C1320722
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Pre-Vaccination Assessment
Beskrivning

Pre-Vaccination Assessment

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0332152
UMLS CUI-3
C0220825
Pre-Vaccination Temperature
Beskrivning

Vaccination, Before, Body Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005903
°C
Pre-Vaccination Temperature - Route
Beskrivning

Vaccination, Before, Body Temperature, Measurement site

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0005903
UMLS CUI [1,4]
C0449687
Laboratory Tests
Beskrivning

Laboratory Tests

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

Collection of blood specimen for laboratory procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Has a urine sample (Pregnancy test - HCG) been taken?
Beskrivning

Urine Specimen Collection, Urine Pregnancy Test

Datatyp

text

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0430056
Results
Beskrivning

Urine Pregnancy Test, Result

Datatyp

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1274040
Vaccine Administration
Beskrivning

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Beskrivning

Administration of vaccine

Datatyp

text

Alias
UMLS CUI [1]
C2368628
Side
Beskrivning

Administration of vaccine, Side

Datatyp

text

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

Administration of vaccine, Anatomic Site

Datatyp

text

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

Drug Administration Routes, Vaccines

Datatyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Has the study vaccine been administered according to the protocol?
Beskrivning

Administration of vaccine, Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Comments
Beskrivning

Administration of vaccine, Comment

Datatyp

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Solicited Adverse Events - Local Symptoms
Beskrivning

Solicited Adverse Events - Local Symptoms

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0877248
UMLS CUI-3
C1457887
UMLS CUI-4
C0205276
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period?
Beskrivning

Vaccination, Adverse Event, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Local Symptoms
Beskrivning

Vaccination, Symptoms, Local

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
Day 0
Beskrivning

Vaccination, Symptoms, Local, Observation Start Day

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C2826301
Day 1
Beskrivning

Vaccination, Symptoms, Local, Day 1

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C1442449
Day 2
Beskrivning

Vaccination, Symptoms, Local, Day 2

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3842676
Day 3
Beskrivning

Vaccination, Symptoms, Local, Day 3

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C3842675
Ongoing after day 3?
Beskrivning

Vaccination, Symptoms, Local, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0549178
Date of last day of symptoms
Beskrivning

Vaccination, Symptoms, Local, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [1,4]
C0806020
Solicited Adverse Events - General Symptoms
Beskrivning

Solicited Adverse Events - General Symptoms

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

Vaccination, Adverse Event, General Symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0159028
General Symptoms
Beskrivning

Vaccination, General symptom

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C2826301
Day 0
Beskrivning

Vaccination, General symptom, Observation Start Day

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C2826301
Day 1
Beskrivning

Vaccination, General symptom, Local, Day 1

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C1442449
Day 2
Beskrivning

Vaccination, General symptom, Day 2

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C3842676
Day 3
Beskrivning

Vaccination, General symptom, Day 3

Datatyp

text

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C3842675
Ongoing after day 3?
Beskrivning

Vaccination, General symptom, Continuous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Date of last day of symptoms
Beskrivning

Vaccination, General symptom, End Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0806020
Causality?
Beskrivning

Vaccination, General symptom, Etiology aspects

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0015127
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Similar models

Visit 4

1 Formulär
  1. StudyEvent: ODM
    1. Visit 4
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administration data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Pre-Vaccination Assessment
C0042196 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
Vaccination, Before, Body Temperature
Item
Pre-Vaccination Temperature
float
C0042196 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
Item
Pre-Vaccination Temperature - Route
text
C0042196 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
Vaccination, Before, Body Temperature, Route
Code List
Pre-Vaccination Temperature - Route
CL Item
Axillary ™  (1)
CL Item
Oral (2)
CL Item
Rectal (™3)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Collection of blood specimen for laboratory procedure
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Item
Has a urine sample (Pregnancy test - HCG) been taken?
text
C0200354 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Urine Specimen Collection, Urine Pregnancy Test
Code List
Has a urine sample (Pregnancy test - HCG) been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
Results
text
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urine Specimen Collection, Urine Pregnancy Test
Code List
Results
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Administration of vaccine
Code List
Vaccine Administration
CL Item
Study vaccine (1)
CL Item
Replacement vial (™2)
CL Item
Wrong vial number (3)
CL Item
™ Not injected (4)
Item
Side
text
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
Side
CL Item
Left (Left)
CL Item
Right (Right)
Item
Site
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
Site
CL Item
Deltoid (Deltoid)
CL Item
Thigh (Thigh)
CL Item
Buttock (Buttock)
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration of vaccine, Side
Code List
Route
CL Item
I.M. (I.M.)
CL Item
S.C. (S.C.)
Administration of vaccine, Study Protocol
Item
Has the study vaccine been administered according to the protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Administration of vaccine, Comment
Item
Comments
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Solicited Adverse Events - Local Symptoms
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
Item
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period?
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Vaccination, Adverse Event, Symptoms, Local
Code List
Has the subject experienced any of the following local (at injection site) solicited signs/symptoms during the solicited period?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (Yes)
Item
Local Symptoms
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Vaccination, Symptoms, Local
Code List
Local Symptoms
CL Item
Redness (Redness)
CL Item
Redness Size (mm) (Redness Size (mm))
CL Item
Swelling (Swelling)
CL Item
Swelling Size (mm) (Swelling Size (mm))
CL Item
Pain (Pain)
CL Item
Pain Intensity (0-4) (Pain Intensity (0-4))
Vaccination, Symptoms, Local, Observation Start Day
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C2826301 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 1
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1442449 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 2
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842676 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Day 3
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842675 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Vaccination, Symptoms, Local, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
Item Group
Solicited Adverse Events - General Symptoms
C0042196 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
Item
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period?
text
C0042196 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
Vaccination, Adverse Event, Symptoms, Local
Code List
Has the subject experienced any of the following general solicited signs or symptoms during the solicited period?
CL Item
Unknown (Unknown)
CL Item
No (No)
CL Item
Yes (Yes)
Item
General Symptoms
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Vaccination, Symptoms, Local
Code List
General Symptoms
CL Item
Fever? (Fever?)
CL Item
Temperature (°C) (Temperature (°C))
CL Item
Measurement Site (Axillary, Oral, Rectal) (Measurement Site (Axillary, Oral, Rectal))
CL Item
Fatigue? (Fatigue?)
CL Item
Intensity of fatigue (0-3) (Intensity of fatigue (0-3))
CL Item
Headache? (Headache?)
CL Item
Intensity of headache (0-3) (Intensity of headache (0-3))
CL Item
Gastrointestinal symptoms? (Gastrointestinal symptoms?)
CL Item
Intensity of gastrointestinal symptoms (0-3) (Intensity of gastrointestinal symptoms (0-3))
Vaccination, General symptom, Observation Start Day
Item
Day 0
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
Vaccination, General symptom, Local, Day 1
Item
Day 1
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
Vaccination, General symptom, Day 2
Item
Day 2
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
Vaccination, General symptom, Day 3
Item
Day 3
text
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
Vaccination, General symptom, Continuous
Item
Ongoing after day 3?
boolean
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Vaccination, General symptom, End Date
Item
Date of last day of symptoms
date
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Vaccination, General symptom, Etiology aspects
Item
Causality?
boolean
C0042196 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
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