ID
38173
Description
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
Keywords
Versions (1)
- 9/24/19 9/24/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 24, 2019
DOI
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License
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
Description
Visit 1 - Administrative
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C1320722
Description
Date of visit
Data type
date
Alias
- UMLS CUI [1]
- C1320303
Description
Subject Number
Data type
text
Alias
- UMLS CUI [1]
- C2348585
Description
I certify that Informed Consent has been obtained prior to any study procedure.
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
Is the subject eligible for the study, according to the criteria listed hereby?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2]
- C0243161
Description
If subject is not eligible, please give the corresponding criterion number
Data type
text
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2,1]
- C0243161
- UMLS CUI [2,2]
- C0237753
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Subject initials - First name
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Description
Subject initials - Family name
Data type
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Other race, please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Height
Data type
integer
Alias
- UMLS CUI [1]
- C0005890
Description
Height unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Description
Weight
Data type
float
Alias
- UMLS CUI [1]
- C0005910
Description
Weight unit
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Description
General medical history/ Physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
If yes, please check appropriate box(es) and give diagnosis.
Data type
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
Description
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Description
Examination
Data type
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Please specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Description
Diagnosis status
Data type
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0011900
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0332152
Description
Pre- vaccination temperature
Data type
float
Measurement units
- °F
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [2]
- C0005903
Description
Temperature Route
Data type
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Description
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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C1548635 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2])
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C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
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