ID
38173
Beschreibung
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
Stichworte
Versionen (1)
- 24.09.19 24.09.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. September 2019
DOI
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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
Beschreibung
Visit 1 - Administrative
Alias
- UMLS CUI-1
- C0545082
- UMLS CUI-2
- C1320722
Beschreibung
Date of visit
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Subject Number
Datentyp
text
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
I certify that Informed Consent has been obtained prior to any study procedure.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschreibung
Is the subject eligible for the study, according to the criteria listed hereby?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2]
- C0243161
Beschreibung
If subject is not eligible, please give the corresponding criterion number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0681850
- UMLS CUI [1,2]
- C1548635
- UMLS CUI [2,1]
- C0243161
- UMLS CUI [2,2]
- C0237753
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Subject initials - First name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1443235
Beschreibung
Subject initials - Family name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2986440
- UMLS CUI [1,2]
- C1301584
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Other race, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Height
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Height unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005890
- UMLS CUI [1,2]
- C1519795
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Weight unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005910
- UMLS CUI [1,2]
- C1519795
Beschreibung
General medical history/ Physical examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschreibung
If yes, please check appropriate box(es) and give diagnosis.
Datentyp
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
Beschreibung
Diagnosis
Alias
- UMLS CUI-1
- C0011900
Beschreibung
Examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0031809
- UMLS CUI [1,2]
- C0205394
Beschreibung
Diagnosis status
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0449438
- UMLS CUI [1,2]
- C0011900
Beschreibung
Diagnosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Pre-Vaccination Assessment
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C0220825
- UMLS CUI-3
- C0332152
Beschreibung
Pre- vaccination temperature
Datentyp
float
Maßeinheiten
- °F
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [2]
- C0005903
Beschreibung
Temperature Route
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0449687
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Ähnliche Modelle
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])