ID

44191

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

Keywords

Versions (4)
  1. 4/11/19 4/11/19 -
  2. 4/11/19 4/11/19 -
  3. 4/11/19 4/11/19 -
  4. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

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License

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

English

Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

1 forms  
Administration
Description

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Informed Consent date:
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Centre number
Description

Centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
If other Race, please specify
Description

If other Race, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
Serious Adverse Events
Description

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Has the subject had any serious adverse event since the last visit?
Description

If Yes, check SAE forms have been submitted to GSK Biologicals.

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify number of SAEs
Description

undefined item

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Description

Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?

Data type

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0201478
Date of Blood sample been taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
Description

Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?

Data type

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
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Description

If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify

Data type

integer

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?

Data type

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
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
Description

If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify

Data type

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
Serology Conclusion of the Blood Sampling Timepoint Year 12
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
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0201473
UMLS CUI [2]
C0475208
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
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.

Data type

boolean

Alias
UMLS CUI [1,1]
C0521144
UMLS CUI [1,2]
C0201478
UMLS CUI [2]
C0475208
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Similar models

Long-Term Follow Up (Year 13) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Informed Consent date
Item
Informed Consent date:
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Centre number
Item
Centre number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Other, please specify (9)
If other Race, please specify
Item
If other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Item Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Has the subject had any serious adverse event since the last visit?
Item
Has the subject had any serious adverse event since the last visit?
boolean
C1519255 (UMLS CUI [1])
undefined item
Item
Specify number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
Date of Blood sample been taken
Item
Date of Blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
Item
Has the subject received since the last visit - A dose of monovalent or combined Hepatitis A and Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1,1])
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])
Item
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
integer
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
Code List
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
CL Item
Hepatitis A vaccine  (1)
CL Item
Hepatitis B vaccine  (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Item
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
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])
Item
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
integer
C3652495 (UMLS CUI [1,1])
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])
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify
Code List
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
CL Item
Hepatitis A immunoglobulins  (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Serology Conclusion of the Blood Sampling Timepoint Year 12
C0036743 (UMLS CUI-1)
C1707478 (UMLS CUI-2)
C0005834 (UMLS CUI-3)
C2348792 (UMLS CUI-4)
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
Item
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
boolean
C0521144 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
Item
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
boolean
C0521144 (UMLS CUI [1,1])
C0201478 (UMLS CUI [1,2])
C0475208 (UMLS CUI [2])
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