ID

33883

Description

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

Keywords

Versions (1)
  1. 1/5/19 1/5/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 5, 2019

DOI

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License

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

English

Visit 1

1 forms  
  1. StudyEvent: ODM
    1. Visit 1
Administration data
Description

Administration data

Alias
UMLS CUI-1
C1320722
Center
Description

Institution Name, Identifier

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Subject initials - First Name
Description

Person Initials, First Name

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1443235
Subject initials - Family Name
Description

Person Initials, Last Name

Data type

text

Alias
UMLS CUI [1,1]
C2986440
UMLS CUI [1,2]
C1301584
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility
Description

Eligibility

Alias
UMLS CUI-1
C0013893
Is the subject eligible for the study, according to the criteria listed hereby?
Description

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
General Medical History / Physical Examination
Description

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
Description

Disease, Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
Organ
Description

Body System or Organ Function

Data type

text

Alias
UMLS CUI [1]
C0678852
Past
Description

Disease, Symptoms, Past

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C1444637
Current
Description

Disease, Symptoms, Current

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0521116
Diagnosis
Description

Disease, Symptoms, Diagnosis

Data type

text

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0011900
Pre-Vaccination Assessment
Description

Pre-Vaccination Assessment

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

Vaccination, Before, Body Temperature

Data type

float

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

Vaccination, Before, Body Temperature, Measurement site

Data type

text

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

Laboratory Tests

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

Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
Description

Collection of blood specimen for laboratory procedure, Antibodies

Data type

text

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0003241
Has a urine sample (Pregnancy test - HCG) been taken?
Description

Urine Specimen Collection, Urine Pregnancy Test

Data type

text

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

Urine Pregnancy Test, Result

Data type

text

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

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Vaccine Administration
Description

Administration of vaccine

Data type

text

Alias
UMLS CUI [1]
C2368628
Side
Description

Administration of vaccine, Side

Data type

text

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

Administration of vaccine, Anatomic Site

Data type

text

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

Drug Administration Routes, Vaccines

Data type

text

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

Administration of vaccine, Study Protocol

Data type

boolean

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

Administration of vaccine, Comment

Data type

text

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

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?
Description

Vaccination, Adverse Event, Symptoms, Local

Data type

text

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

Vaccination, Symptoms, Local

Data type

text

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

Vaccination, Symptoms, Local, Observation Start Day

Data type

text

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

Vaccination, Symptoms, Local, Day 1

Data type

text

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

Vaccination, Symptoms, Local, Day 2

Data type

text

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

Vaccination, Symptoms, Local, Day 3

Data type

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?
Description

Vaccination, Symptoms, Local, Continuous

Data type

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
Description

Vaccination, Symptoms, Local, End Date

Data type

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
Description

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?
Description

Vaccination, Adverse Event, General Symptom

Data type

text

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

Vaccination, General symptom

Data type

text

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

Vaccination, General symptom, Observation Start Day

Data type

text

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

Vaccination, General symptom, Local, Day 1

Data type

text

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

Vaccination, General symptom, Day 2

Data type

text

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

Vaccination, General symptom, Day 3

Data type

text

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

Vaccination, General symptom, Continuous

Data type

boolean

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

Vaccination, General symptom, End Date

Data type

date

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

Vaccination, General symptom, Etiology aspects

Data type

boolean

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

Visit 1

1 forms
  1. StudyEvent: ODM
    1. Visit 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration data
C1320722 (UMLS CUI-1)
Institution Name, Identifier
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent Date in time
Item
Informed Consent date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Person Initials, First Name
Item
Subject initials - First Name
text
C2986440 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
Person Initials, Last Name
Item
Subject initials - Family Name
text
C2986440 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
CL Item
White (1)
CL Item
Black (2)
CL Item
Oriental (3)
CL Item
Other, please specify (4)
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Eligibility
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Is the subject eligible for the study, according to the criteria listed hereby?
boolean
C0013893 (UMLS CUI [1])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Disease, Symptoms
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Item
Organ
text
C0678852 (UMLS CUI [1])
Body System or Organ Function
Code List
Organ
CL Item
Cutaneous (1)
CL Item
Eyes (2)
CL Item
Ears-nose-throat (3)
CL Item
Cardiovascular (4)
CL Item
Respiratory (5)
CL Item
Gastrointestinal (6)
CL Item
Musculoskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (9)
CL Item
Haematology (10)
CL Item
Allergies (11)
CL Item
Endocrine (12)
CL Item
Other (specify) (13)
Disease, Symptoms, Past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
Disease, Symptoms, Current
Item
Current
boolean
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
Disease, Symptoms, Diagnosis
Item
Diagnosis
text
C0012634 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
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 blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
text
C0005834 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Collection of blood specimen for laboratory procedure, Antibodies
Code List
Has a blood sample been taken for RF1-like antibodies testing (only for 50 subjects per group)?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
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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