ID
33883
Descripción
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
Palabras clave
Versiones (1)
- 5/1/19 5/1/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
5 de enero de 2019
DOI
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Licencia
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
Descripción
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
Person Initials, First Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Descripción
Person Initials, Last Name
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Descripción
Patient date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Racial group
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0034510
Descripción
Body Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Eligibility
Alias
- UMLS CUI-1
- C0013893
Descripción
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Descripción
Disease, Symptoms
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
Descripción
Body System or Organ Function
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0678852
Descripción
Disease, Symptoms, Past
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C1444637
Descripción
Disease, Symptoms, Current
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0521116
Descripción
Disease, Symptoms, Diagnosis
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0011900
Descripción
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C0220825
Descripción
Vaccination, Before, Body Temperature
Tipo de datos
float
Unidades de medida
- °C
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
Descripción
Vaccination, Before, Body Temperature, Measurement site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0005903
- UMLS CUI [1,4]
- C0449687
Descripción
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Descripción
Collection of blood specimen for laboratory procedure
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0005834
Descripción
Collection of blood specimen for laboratory procedure, Antibodies
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0003241
Descripción
Urine Specimen Collection, Urine Pregnancy Test
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0430056
Descripción
Urine Pregnancy Test, Result
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Descripción
Vaccine Administration
Alias
- UMLS CUI-1
- C2368628
Descripción
Administration of vaccine
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2368628
Descripción
Administration of vaccine, Side
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0441987
Descripción
Administration of vaccine, Anatomic Site
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
Descripción
Drug Administration Routes, Vaccines
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Descripción
Administration of vaccine, Study Protocol
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Descripción
Administration of vaccine, Comment
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0947611
Descripción
Solicited Adverse Events - Local Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C1457887
- UMLS CUI-4
- C0205276
Descripción
Vaccination, Adverse Event, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1457887
- UMLS CUI [1,4]
- C0205276
Descripción
Vaccination, Symptoms, Local
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
Descripción
Vaccination, Symptoms, Local, Observation Start Day
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C2826301
Descripción
Vaccination, Symptoms, Local, Day 1
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C1442449
Descripción
Vaccination, Symptoms, Local, Day 2
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842676
Descripción
Vaccination, Symptoms, Local, Day 3
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C3842675
Descripción
Vaccination, Symptoms, Local, Continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0549178
Descripción
Vaccination, Symptoms, Local, End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205276
- UMLS CUI [1,4]
- C0806020
Descripción
Solicited Adverse Events - General Symptoms
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0159028
Descripción
Vaccination, Adverse Event, General Symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0159028
Descripción
Vaccination, General symptom
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Descripción
Vaccination, General symptom, Observation Start Day
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C2826301
Descripción
Vaccination, General symptom, Local, Day 1
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C1442449
Descripción
Vaccination, General symptom, Day 2
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842676
Descripción
Vaccination, General symptom, Day 3
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C3842675
Descripción
Vaccination, General symptom, Continuous
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0549178
Descripción
Vaccination, General symptom, End Date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0159028
- UMLS CUI [1,3]
- C0806020
Descripción
Vaccination, General symptom, Etiology aspects
Tipo de datos
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])