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)
- 1/5/19 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
Visit 1
- StudyEvent: ODM
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Person Initials, First Name
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Description
Person Initials, Last Name
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Racial group
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Eligibility
Alias
- UMLS CUI-1
- C0013893
Description
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
Disease, Symptoms
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
Description
Body System or Organ Function
Data type
text
Alias
- UMLS CUI [1]
- C0678852
Description
Disease, Symptoms, Past
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1444637
Description
Disease, Symptoms, Current
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0521116
Description
Disease, Symptoms, Diagnosis
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011900
Description
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0220825
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
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
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Collection of blood specimen for laboratory procedure
Data type
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Collection of blood specimen for laboratory procedure, Antibodies
Data type
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0003241
Description
Urine Specimen Collection, Urine Pregnancy Test
Data type
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0430056
Description
Urine Pregnancy Test, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Description
Administration of vaccine
Data type
text
Alias
- UMLS CUI [1]
- C2368628
Description
Administration of vaccine, Side
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0441987
Description
Administration of vaccine, Anatomic Site
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
Description
Drug Administration Routes, Vaccines
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Administration of vaccine, Study Protocol
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Administration of vaccine, Comment
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0947611
Description
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
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
Description
Vaccination, Symptoms, Local
Data type
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
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
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
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
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
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
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
Description
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0159028
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
Description
Vaccination, General symptom
Data type
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
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
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
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
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
Description
Vaccination, General symptom, Continuous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
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
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
Similar models
Visit 1
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C1457887 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
C0332152 (UMLS CUI-2)
C0220825 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [1,3])
C0449687 (UMLS CUI [1,4])
C0003241 (UMLS CUI [1,2])
C0430056 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C1457887 (UMLS CUI-3)
C0205276 (UMLS CUI-4)
C0877248 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C2826301 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1442449 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842676 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C3842675 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0806020 (UMLS CUI [1,4])
C0877248 (UMLS CUI-2)
C0159028 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C0159028 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C2826301 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C1442449 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C3842676 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C3842675 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0159028 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])