ID
36047
Description
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
Mots-clés
Versions (4)
- 11/04/2019 11/04/2019 -
- 11/04/2019 11/04/2019 -
- 11/04/2019 11/04/2019 -
- 20/09/2021 20/09/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
11 avril 2019
DOI
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Licence
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 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Centre number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0600091
- UMLS CUI [1,2]
- C0019994
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Race
Type de données
integer
Alias
- UMLS CUI [1]
- C0034510
Description
If other Race, please specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Description
Serious Adverse Events
Alias
- UMLS CUI-1
- C1519255
Description
If Yes, check SAE forms have been submitted to GSK Biologicals.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1519255
Description
undefined item
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0449788
- UMLS CUI [1,2]
- C1519255
Description
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Description
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2,1]
- C0005834
- UMLS CUI [2,2]
- C0948254
Description
Please complete only if different from visit date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
Description
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
Type de données
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
Description
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0170300
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [2,1]
- C2240392
- UMLS CUI [2,2]
- C2348235
Description
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Type de données
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
Description
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify
Type de données
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
Description
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
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0201473
- UMLS CUI [2]
- C0475208
Description
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.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0521144
- UMLS CUI [1,2]
- C0948254
- UMLS CUI [2]
- C0475208
Similar models
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])