ID

44196

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

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  1. 11.04.19 11.04.19 -
  2. 20.09.21 20.09.21 -
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GlaxoSmithKline

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20. September 2021

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Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718

Englisch

Long-Term Follow Up (Year 14) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

1 Formulare  
Administration
Beschreibung

Administration

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent date:
Beschreibung

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

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Centre number
Beschreibung

Centre number

Datentyp

integer

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

integer

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

If other Race, please specify

Datentyp

text

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

Serious Adverse Events

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

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

Datentyp

boolean

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

undefined item

Datentyp

integer

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

Laboratory Tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
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]
C0201478
Date of Blood sample been taken
Beschreibung

Please complete only if different from visit date

Datentyp

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?
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
If subject has recieved a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine, please specify
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
Has the subject received since the last visit - A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
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
If subject has received a dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding, please specify.
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
Serology Conclusion of the Blood Sampling Timepoint Year 13
Beschreibung

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
Has the patient become seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml)?
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
Has the patient lost seroprotective titres for anti-HBs antibodies (i.e. titres < 10 mIU/ml)?
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]
C0201478
UMLS CUI [2]
C0475208
If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
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
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Ähnliche Modelle

Long-Term Follow Up (Year 14) - Informed Consent; Demographics; Laboratory Tests; Serology Conclusion of Blood Sampling

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administration
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (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 13
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])
If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
Item
If the subject fulfills criteria for booster administration, does he agree to receive an additional vaccination?
boolean
C0419731 (UMLS CUI [1,1])
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])
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