ID

42730

Beschreibung

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up VISIT 15 - YEAR 10 - 120 MONTHS + 2 MONTHS Study ID: 100566 Clinical Study ID: 100566 Study Title: Evaluate Persistence of Immune Response of GSK Biologicals’ TWINRIX™ Vaccine Administered According to 0,6 Month Schedule Versus TWINRIX™ JUNIOR Administered According to 0,1,6 Month Schedule, in Subjects Aged 12-15 years at Time of First Vaccine Dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197119 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: BIO HAB; Twinrix Study Indication: Hepatitis A; Hepatitis B

Stichworte

Versionen (2)
  1. 19.08.17 19.08.17 -
  2. 17.09.21 17.09.21 -
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glaxoSmithKline

Hochgeladen am

17. September 2021

DOI

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GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 15

Englisch

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 15

1 Formulare  
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
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
Center number
Beschreibung

LONG-TERM FOLLOW-UP PREVIOUS STUDY 208127/106 (EXT HAB-084) – Month 60 Subject number will be the same as in the previous study.

Datentyp

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
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

Blood sample taken for testing anti-HAV or anti-HBs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0201473
UMLS CUI [2,1]
C1277698
UMLS CUI [2,2]
C0201478
Date blood sample was taken
Beschreibung

Only answer if blood sample for testing anti-HAV or anti-HBs was taken and if the date the blood sample was taken is different from visit date.

Datentyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005834
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
Beschreibung

A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C0170300
UMLS CUI [2]
C2240392
UMLS CUI [3]
C5397396
Follow-up studies
Beschreibung

Follow-up studies

Alias
UMLS CUI-1
C0016441
UMLS CUI-2
C0042210
Would the subject be willing to participate in a follow-up study?
Beschreibung

Would the subject be willing to participate in a follow-up study?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0600109
Please specify the most appropriate reason
Beschreibung

I you answered previous question with 'no' please specify the most appropriate reason.

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392360
Please specify Adverse Event or Serious adverse event.
Beschreibung

Please specify Adverse Event or Serious adverse event

Datentyp

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1521902
Please specify other reason for not willing to participate in follow-up studies
Beschreibung

other reason for non-participation

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Occurrence of serious adverse event
Beschreibung

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study period ?
Beschreibung

Serious Adverse Event during the study period

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2349977
Specify total number of SAE's
Beschreibung

Only answer if you answered last question with 'yes'.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Investigator's signature
Beschreibung

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beschreibung

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.

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Investigator signature date
Beschreibung

Investigator signature date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Tracking Document - Reason for non participation
Beschreibung

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0392360
Previous subject number
Beschreibung

Previous subject number

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Please document reason for non participation
Beschreibung

reason for non participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0392360
Subject not eligible? - please specify criteria that are not full-filled.
Beschreibung

If you chose 'Subject not eligible' as reason for non participation, please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C3828770
UMLS CUI [1,2]
C1521902
Subject eligible but not willing to participate due to:
Beschreibung

Only, answer this question, if you chose 'Subject eligible but not willing to participate' as reason for non participation.

Datentyp

integer

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Please specify 'adverse events or serious adverse event'.
Beschreibung

If you chose 'adverse events or serious adverse event', please specify.

Datentyp

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1521902
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C1521902
Please specify 'other'.
Beschreibung

Please specify 'other' reason for eligible but not-willing to participate in study.

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
Subject died on:
Beschreibung

Please fill in Date of death, if you chose 'subject died on' as reason for non participation

Datentyp

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Beschreibung

Date of contact

Datentyp

date

Alias
UMLS CUI [1]
C0805839
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Ähnliche Modelle

GSK TWINRIX™ Hepatitis A and B Vaccine: Persistence of Immune Response in 0,6 Month vs. 0,1,6 Month Schedule NCT00197119 - Longterm Follow-up Visit 15

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed consent date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (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 Group
Laboratory Tests
C0022885 (UMLS CUI-1)
Blood sample taken for testing anti-HAV or anti-HBs
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
boolean
C1277698 (UMLS CUI [1,1])
C0201473 (UMLS CUI [1,2])
C1277698 (UMLS CUI [2,1])
C0201478 (UMLS CUI [2,2])
Blood sample date
Item
Date blood sample was taken
date
C0011008 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine
Item
Has the subject received since the last visit: A dose of monovalent or combined Hepatitis A or Hepatitis B vaccine?
boolean
C0170300 (UMLS CUI [1])
C2240392 (UMLS CUI [2])
C5397396 (UMLS CUI [3])
Item Group
Follow-up studies
C0016441 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Item
Would the subject be willing to participate in a follow-up study?
integer
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Would the subject be willing to participate in a follow-up study?
Code List
Would the subject be willing to participate in a follow-up study?
CL Item
Yes (1)
CL Item
No (2)
Item
Please specify the most appropriate reason
text
C2348568 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
undefined item
Code List
Please specify the most appropriate reason
CL Item
Adverse Events or Serious adverse event (1)
CL Item
Other (2)
Please specify Adverse Event or Serious adverse event
Item
Please specify Adverse Event or Serious adverse event.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
other reason for non-participation
Item
Please specify other reason for not willing to participate in follow-up studies
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious Adverse Event during the study period
Item
Did the subject experience any Serious Adverse Event during the study period ?
boolean
C1519255 (UMLS CUI [1,1])
C2349977 (UMLS CUI [1,2])
number of Serious adverse event
Item
Specify total number of SAE's
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Item Group
Tracking Document - Reason for non participation
C2348568 (UMLS CUI-1)
C0392360 (UMLS CUI-2)
Previous subject number
Item
Previous subject number
text
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please document reason for non participation
integer
C2348568 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
reason for non participation
Code List
Please document reason for non participation
CL Item
Subject not eligible? - please specify criteria that are not full-filled: (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject died on: (4)
subject not meeting criteria please specify
Item
Subject not eligible? - please specify criteria that are not full-filled.
text
C3828770 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item
Subject eligible but not willing to participate due to:
integer
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Eligible but Refused due to
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events, or serious adverse event (1)
CL Item
other (2)
specify adverse events or serious adverse event
Item
Please specify 'adverse events or serious adverse event'.
text
C0559546 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1521902 (UMLS CUI [2,2])
specify other reason
Item
Please specify 'other'.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Date of death
Item
Subject died on:
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
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