ID

26195

Description

Phase III, open, randomized study, in two centres, to demonstrate the equivalence of the 0, 12 month schedule to the 0, 6 month schedule with respect to the immunogenicity and to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ combined hepatitis A/ hepatitis B vaccine TWINRIX™ ADULT (720 EL. U. of hepatitis A antigen/ 20 μg of recombinant hepatitis B surface antigen) in healthy volunteers aged from 12 to 15 years inclusive. NCT00197171

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

Glaxo Smith Kline

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Long Term Follow up Year 5

English

Long Term Follow up Year 5

1 forms  
Long Term Follow up Visit 7
Description

Long Term Follow up Visit 7

Alias
UMLS CUI-1
C1517942
Center
Description

Study site identifier

Data type

text

Alias
UMLS CUI [1]
C2826692
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
I certify that Informed Consent has been obtained prior to any study procedure.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Informed Consent Date
Description

Informed Consent Date

Data type

date

Alias
UMLS CUI [1]
C2985782
Previous Studies
Description

Subject number will be the same as in the previous study.

Data type

integer

Alias
UMLS CUI [1]
C2242969
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

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

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
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

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Sample Collection Date
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C1302413
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Description

Vaccination since last visit

Data type

boolean

Alias
UMLS CUI [1,1]
C3543421
UMLS CUI [1,2]
C0589121
If yes, please specify vaccine
Description

Hepatitis vaccines

Data type

integer

Alias
UMLS CUI [1]
C3543421
Has the subject received a dose of Hepatitis A and/or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Description

Hepatitis A and/or Hepatitis B immunoglobulins past 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0062525
UMLS CUI [1,3]
C3828652
If yes, please specify
Description

Hepatitis A and/or Hepatitis B immunoglobulins

Data type

integer

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C0062525
Follow up Studies
Description

Follow up Studies

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Description

Follow-up studies

Data type

boolean

Alias
UMLS CUI [1]
C0016441
If No, please specify the most appropriate reason
Description

Follow up Studies reason for withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0392360
Please specify Adverse event,Serious adverse event or other reason
Description

Specify Reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C1521902
Investigator Signature
Description

Investigator Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Description

Confirmation

Data type

boolean

Alias
UMLS CUI [1]
C0750484
Investigator Signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Date
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C1549507
Tracking Document Reason for non participation
Description

Tracking Document Reason for non participation

Alias
UMLS CUI-1
C3889409
Previous subject number
Description

Previous subject number

Data type

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Previous Protocol number
Description

Previous Protocol number

Data type

integer

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C0205156
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Reason for non participation
Description

Reason for non participation

Data type

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Please specify criteria that are not fullfilled
Description

Reason for non participation

Data type

text

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Please specify adverse events,serious adverse event or other reason for subject withdrawal
Description

Reason for non participation

Data type

text

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Date of death
Description

Reason for non participation

Data type

date

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Date of Contact
Description

Last seen

Data type

date

Alias
UMLS CUI [1]
C0805839
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Similar models

Long Term Follow up Year 5

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Long Term Follow up Visit 7
C1517942 (UMLS CUI-1)
Study site identifier
Item
Center
text
C2826692 (UMLS CUI [1])
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure.
boolean
C0021430 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item
Previous Studies
integer
C2242969 (UMLS CUI [1])
Previous Study
Code List
Previous Studies
CL Item
208127/082 (HAB-082) (1)
CL Item
208127/103 (HAB-082 Y2) (2)
CL Item
208127/104 (HAB-082 Y3) (3)
Item Group
Demographics
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
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
Other,please specify (9)
Race
Item
Race, if other please specify
text
C0034510 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C0005834 (UMLS CUI [1])
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI [1])
Vaccination since last visit
Item
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C3543421 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
Item
If yes, please specify vaccine
integer
C3543421 (UMLS CUI [1])
Hepatitis vaccines
Code List
If yes, please specify vaccine
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Hepatitis A and/or Hepatitis B immunoglobulins past 6 months
Item
Has the subject received a dose of Hepatitis A and/or Hepatitis B immunoglobulins within 6 months prior to bleeding?
boolean
C3652495 (UMLS CUI [1,1])
C0062525 (UMLS CUI [1,2])
C3828652 (UMLS CUI [1,3])
Item
If yes, please specify
integer
C3652495 (UMLS CUI [1,1])
C0062525 (UMLS CUI [1,2])
Hepatitis A and/or Hepatitis B immunoglobulins
Code List
If yes, please specify
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item Group
Follow up Studies
C0016441 (UMLS CUI-1)
Follow-up studies
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1])
Item
If No, please specify the most appropriate reason
integer
C0016441 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Follow up Studies reason for withdrawal
Code List
If No, please specify the most appropriate reason
CL Item
Adverse Events or Serious Adverse Events (1)
CL Item
Other (2)
Specify Reason for withdrawal
Item
Please specify Adverse event,Serious adverse event or other reason
text
C2349954 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Investigator Signature
C2346576 (UMLS CUI-1)
Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
boolean
C0750484 (UMLS CUI [1])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C1549507 (UMLS CUI [1])
Item Group
Tracking Document Reason for non participation
C3889409 (UMLS CUI-1)
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item
Previous Protocol number
integer
C2348563 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Study
Code List
Previous Protocol number
CL Item
208127/082 (HAB-082) (1)
CL Item
208127/103 (HAB-082 Y2) (2)
CL Item
208127/104 (HAB-082 Y3) (3)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for non participation
Code List
Reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not fulfilled (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to AE,SAE or other reason (3)
CL Item
Subject died on: (4)
Reason for non participation
Item
Please specify criteria that are not fullfilled
text
C1516637 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for non participation
Item
Please specify adverse events,serious adverse event or other reason for subject withdrawal
text
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for non participation
Item
Date of death
date
C1148348 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Last seen
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
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