ID
36047
Beschreibung
Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B
Stichworte
Versionen (4)
- 11.04.19 11.04.19 -
- 11.04.19 11.04.19 -
- 11.04.19 11.04.19 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
11. April 2019
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Centre number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0019994
Beschreibung
Date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Race
Datentyp
integer
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
If other Race, please specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Beschreibung
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Beschreibung
If Yes, check SAE forms have been submitted to GSK Biologicals.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
undefined item
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Beschreibung
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0948254
Beschreibung
Please complete only if different from visit date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Beschreibung
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C0545082
- UMLS CUI [2,3]
- C1517741
- UMLS CUI [2,4]
- C1711239
Beschreibung
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Beschreibung
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0019080
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C0019080
- UMLS CUI [2,3]
- C0332152
Beschreibung
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3652495
- UMLS CUI [1,2]
- C0019080
- UMLS CUI [1,3]
- C0332152
- UMLS CUI [1,4]
- C2348235
- UMLS CUI [2,1]
- C0062525
- UMLS CUI [2,2]
- C0019080
- UMLS CUI [2,3]
- C0332152
- UMLS CUI [2,4]
- C2348235
Beschreibung
Serology Conclusion of the Blood Sampling Timepoint Year 12
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0005834
- UMLS CUI-4
- C2348792
Beschreibung
If YES to any of above question, please vaccine the subject (either Engerix, Havrix or Twinrix Adult) as appropriate 12 months after the blood sample done at year 12 and complete the entire CRF. If NO to both questions, please complete the Study Conclusion section only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2]
- C0475208
Beschreibung
If YES to any of above question, please vaccine the subject (either Engerix, Havrix or Twinrix Adult) as appropriate 12 months after the blood sample done at year 12 and complete the entire CRF. If NO to both questions, please complete the Study Conclusion section only.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0948254
- UMLS CUI [2]
- C0475208
Ähnliche Modelle
Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling
C0019994 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0948254 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C2240392 (UMLS CUI [2,1])
C0545082 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
C1711239 (UMLS CUI [2,4])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0019080 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0062525 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C2348235 (UMLS CUI [2,4])
C1707478 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C2348792 (UMLS CUI-4)
C0201473 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])
C0948254 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])