ID
44196
Descripción
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
Palabras clave
Versiones (2)
- 11/4/19 11/4/19 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de septiembre de 2021
DOI
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Licencia
Creative Commons BY-NC 3.0
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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718
Long-Term Follow Up (Year 14) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling
Descripción
Demographics
Alias
- UMLS CUI-1
- C1704791
Descripción
Centre number
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0019994
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Gender
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
Race
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
If other Race, please specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Descripción
If Yes, check SAE forms have been submitted to GSK Biologicals.
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
undefined item
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Descripción
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Descripción
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0201478
Descripción
Please complete only if different from visit date
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Descripción
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
Tipo de datos
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
Descripción
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Descripción
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Tipo de datos
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
Descripción
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify
Tipo de datos
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
Descripción
Serology Conclusion of the Blood Sampling Timepoint Year 13
Alias
- UMLS CUI-1
- C0036743
- UMLS CUI-2
- C1707478
- UMLS CUI-3
- C0005834
- UMLS CUI-4
- C2348792
Descripción
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2]
- C0475208
Descripción
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0201478
- UMLS CUI [2]
- C0475208
Descripción
If yes → Please complete the entire CRF If no → Please complete the study conclusion only
Tipo de datos
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
Similar models
Long-Term Follow Up (Year 14) - 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])
C0201478 (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])
C0201478 (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])