ID
38173
Beskrivning
Study ID: 103860/277 Clinical Study ID: 103860/277 Study Title: Phase III study of immunogenicity and safety of 3 doses of GSK Biologicals' thimerosal-free hepatitis B vaccine compared to the US-licensed GSK Biologicals' preservative-free hepatitis B vaccine when administered intramuscularly on a 0, 1, 6-month schedule to healthy infants in their first two weeks of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: BIO HBV; Engerix-B Study Indication: Hepatitis B
Nyckelord
Versioner (1)
- 2019-09-24 2019-09-24 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
24 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Immunogenicity and safety of hepatitis B vaccine when administered intramuscularly to healthy infants in their first two weeks of life (103860/277)
Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests
Beskrivning
Visit 1 - Administrative
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C1320722
Beskrivning
Date of visit
Datatyp
date
Alias
- UMLS CUI [1]
- C1320303
Beskrivning
Subject Number
Datatyp
text
Alias
- UMLS CUI [1]
- C2348585
Beskrivning
I certify that Informed Consent has been obtained prior to any study procedure.
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beskrivning
Is the subject eligible for the study, according to the criteria listed hereby?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2]
- C0243161
Beskrivning
If subject is not eligible, please give the corresponding criterion number
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2,1]
- C0243161
- UMLS CUI [2,2]
- C0237753
Beskrivning
Demographics
Alias
- UMLS CUI-1
- C1704791
Beskrivning
Subject initials - First name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Beskrivning
Subject initials - Family name
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Beskrivning
Gender
Datatyp
text
Alias
- UMLS CUI [1]
- C0079399
Beskrivning
Race
Datatyp
text
Alias
- UMLS CUI [1]
- C0034510
Beskrivning
Other race, please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beskrivning
Height
Datatyp
integer
Alias
- UMLS CUI [1]
- C0005890
Beskrivning
Height unit
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beskrivning
Weight
Datatyp
float
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Weight unit
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beskrivning
General medical history/ Physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beskrivning
If yes, please check appropriate box(es) and give diagnosis.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0521987
- UMLS CUI [1,2]
- C2603343
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [2,1]
- C0037088
- UMLS CUI [2,2]
- C2603343
- UMLS CUI [2,3]
- C0332152
Beskrivning
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Beskrivning
Examination
Datatyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Please specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beskrivning
Diagnosis status
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0011900
Beskrivning
Diagnosis
Datatyp
text
Alias
- UMLS CUI [1]
- C0011900
Beskrivning
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0332152
Beskrivning
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Similar models
Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C1320722 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2])
C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0031809 (UMLS CUI-2)
C2603343 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C2603343 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0449687 (UMLS CUI [1,2])