ID
33883
Beschreibung
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
Stichworte
Versionen (1)
- 05.01.19 05.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. Januar 2019
DOI
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Lizenz
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
Beschreibung
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Person Initials, First Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Beschreibung
Person Initials, Last Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Beschreibung
Patient date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Racial group
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Eligibility
Alias
- UMLS CUI-1
- C0013893
Beschreibung
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschreibung
Disease, Symptoms
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
Beschreibung
Body System or Organ Function
Datentyp
text
Alias
- UMLS CUI [1]
- C0678852
Beschreibung
Disease, Symptoms, Past
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1444637
Beschreibung
Disease, Symptoms, Current
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0521116
Beschreibung
Disease, Symptoms, Diagnosis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011900
Beschreibung
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0220825
Beschreibung
Vaccination, Before, Body Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
Beschreibung
Vaccination, Before, Body Temperature, Measurement site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
- UMLS CUI [1,4]
- C0449687
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Collection of blood specimen for laboratory procedure
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Collection of blood specimen for laboratory procedure, Antibodies
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0003241
Beschreibung
Urine Specimen Collection, Urine Pregnancy Test
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0430056
Beschreibung
Urine Pregnancy Test, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Beschreibung
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschreibung
Administration of vaccine
Datentyp
text
Alias
- UMLS CUI [1]
- C2368628
Beschreibung
Administration of vaccine, Side
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0441987
Beschreibung
Administration of vaccine, Anatomic Site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
Beschreibung
Drug Administration Routes, Vaccines
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschreibung
Administration of vaccine, Study Protocol
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschreibung
Administration of vaccine, Comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0947611
Beschreibung
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Beschreibung
Vaccination, Adverse Event, Symptoms, Local
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Beschreibung
Vaccination, Symptoms, Local
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschreibung
Vaccination, Symptoms, Local, Observation Start Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C2826301
Beschreibung
Vaccination, Symptoms, Local, Day 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C1442449
Beschreibung
Vaccination, Symptoms, Local, Day 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842676
Beschreibung
Vaccination, Symptoms, Local, Day 3
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842675
Beschreibung
Vaccination, Symptoms, Local, Continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0549178
Beschreibung
Vaccination, Symptoms, Local, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0806020
Beschreibung
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0159028
Beschreibung
Vaccination, Adverse Event, General Symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0159028
Beschreibung
Vaccination, General symptom
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Beschreibung
Vaccination, General symptom, Observation Start Day
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Beschreibung
Vaccination, General symptom, Local, Day 1
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1442449
Beschreibung
Vaccination, General symptom, Day 2
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842676
Beschreibung
Vaccination, General symptom, Day 3
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842675
Beschreibung
Vaccination, General symptom, Continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Beschreibung
Vaccination, General symptom, End Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0806020
Beschreibung
Vaccination, General symptom, Etiology aspects
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0015127
Ähnliche Modelle
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])