ID
36109
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 (2)
- 15.04.19 15.04.19 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
15. 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 15) - 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
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 14
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0005834
- UMLS CUI-4
- C2348792
Beschreibung
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2]
- C0475208
Beschreibung
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0948254
- UMLS CUI [2]
- C0475208
Beschreibung
If yes → Please complete the entire CRF If no → Please complete the study conclusion only
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0419731
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1706712
- UMLS CUI [2,1]
- C0419739
- UMLS CUI [2,2]
- C2368628
- UMLS CUI [2,3]
- C1706712
Ähnliche Modelle
Long-Term Follow Up (Year 15) - 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])
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])
C2368628 (UMLS CUI [1,2])
C1706712 (UMLS CUI [1,3])
C0419739 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
C1706712 (UMLS CUI [2,3])