ID
38173
Beschrijving
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
Trefwoorden
Versies (1)
- 24-09-19 24-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
24 september 2019
DOI
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Licentie
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
Beschrijving
Visit 1 - Administrative
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C1320722
Beschrijving
Date of visit
Datatype
date
Alias
- UMLS CUI [1]
- C1320303
Beschrijving
Subject Number
Datatype
text
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
I certify that Informed Consent has been obtained prior to any study procedure.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschrijving
Is the subject eligible for the study, according to the criteria listed hereby?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2]
- C0243161
Beschrijving
If subject is not eligible, please give the corresponding criterion number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2,1]
- C0243161
- UMLS CUI [2,2]
- C0237753
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Subject initials - First name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Beschrijving
Subject initials - Family name
Datatype
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Race
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Other race, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschrijving
Height
Datatype
integer
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Height unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschrijving
Weight
Datatype
float
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Weight unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschrijving
General medical history/ Physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
If yes, please check appropriate box(es) and give diagnosis.
Datatype
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
Beschrijving
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Beschrijving
Examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beschrijving
Diagnosis status
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0011900
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0332152
Beschrijving
Pre- vaccination temperature
Datatype
float
Maateenheden
- °F
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [2]
- C0005903
Beschrijving
Temperature Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
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Visit 1 - Demographics; General medical history/ Physical examination; Pre-Vaccination Assessment; Laboratory Tests
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C0243161 (UMLS CUI [2])
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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])
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