ID
33887
Beschrijving
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
Trefwoorden
Versies (1)
- 05-01-19 05-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 januari 2019
DOI
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Licentie
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 4
- StudyEvent: ODM
Beschrijving
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0220825
Beschrijving
Vaccination, Before, Body Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
Beschrijving
Vaccination, Before, Body Temperature, Measurement site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
- UMLS CUI [1,4]
- C0449687
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Collection of blood specimen for laboratory procedure
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Urine Specimen Collection, Urine Pregnancy Test
Datatype
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0430056
Beschrijving
Urine Pregnancy Test, Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Beschrijving
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Beschrijving
Administration of vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Administration of vaccine, Side
Datatype
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0441987
Beschrijving
Administration of vaccine, Anatomic Site
Datatype
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
Beschrijving
Drug Administration Routes, Vaccines
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
Administration of vaccine, Study Protocol
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Administration of vaccine, Comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0947611
Beschrijving
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Beschrijving
Vaccination, Adverse Event, Symptoms, Local
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Beschrijving
Vaccination, Symptoms, Local
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Beschrijving
Vaccination, Symptoms, Local, Observation Start Day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C2826301
Beschrijving
Vaccination, Symptoms, Local, Day 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C1442449
Beschrijving
Vaccination, Symptoms, Local, Day 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842676
Beschrijving
Vaccination, Symptoms, Local, Day 3
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842675
Beschrijving
Vaccination, Symptoms, Local, Continuous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0549178
Beschrijving
Vaccination, Symptoms, Local, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0806020
Beschrijving
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0159028
Beschrijving
Vaccination, Adverse Event, General Symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0159028
Beschrijving
Vaccination, General symptom
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Beschrijving
Vaccination, General symptom, Observation Start Day
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Beschrijving
Vaccination, General symptom, Local, Day 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1442449
Beschrijving
Vaccination, General symptom, Day 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842676
Beschrijving
Vaccination, General symptom, Day 3
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842675
Beschrijving
Vaccination, General symptom, Continuous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Beschrijving
Vaccination, General symptom, End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0806020
Beschrijving
Vaccination, General symptom, Etiology aspects
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0015127
Similar models
Visit 4
- StudyEvent: ODM
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])
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])