ID
38314
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 (2)
- 08-10-19 08-10-19 -
- 09-10-19 09-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 oktober 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 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration
Beschrijving
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschrijving
Month 5 - Phone Contact
Alias
- UMLS CUI-1
- C0337611
- UMLS CUI-2
- C0039457
- UMLS CUI-3
- C0439231
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
Vaccine Administration (Engerix-B- Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0116078
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccination Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Has the study vaccine been administered according to the Protocol?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Please check all items
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vaccine Administration (Infanrix Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1964896
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccination Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Has the study vaccine been administered according to the Protocol?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Please check all items
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vaccine Administration (Prevnar Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0876134
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccination Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Has the study vaccine been administered according to the Protocol?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Please check all items
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vaccine Administration (HibTITER Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C1524027
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccination Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vaccine Administration (Comvax Vaccine)
Alias
- UMLS CUI-1
- C2368628
- UMLS CUI-2
- C0535643
Beschrijving
(only one box must be checked)
Datatype
integer
Alias
- UMLS CUI [1]
- C2368628
Beschrijving
Vaccination Side/ Site Route
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C1515974
- UMLS CUI [1,3]
- C0013153
- UMLS CUI [1,4]
- C0441987
Beschrijving
Has the study vaccine been administered according to the Protocol?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Beschrijving
Please check all items
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C234856
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Visit 3 - Laboratory Tests; Phone Contact Month 5; Visit 4 - Pre-Vacciantion Assessment; Vaccine Administration
C0039457 (UMLS CUI-2)
C0439231 (UMLS CUI-3)
C0220825 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0449687 (UMLS CUI [1,2])
C0116078 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])
C1964896 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])
C0876134 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])
C1524027 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C0535643 (UMLS CUI-2)
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C0441987 (UMLS CUI [1,4])
C2348563 (UMLS CUI [1,2])
C234856 (UMLS CUI [1,2])