Information:
Fel:
ID
26195
Beskrivning
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
Nyckelord
Versioner (1)
- 2017-10-11 2017-10-11 -
Rättsinnehavare
Glaxo Smith Kline
Uppladdad den
11 oktober 2017
DOI
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Licens
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
Long Term Follow up Year 5
- StudyEvent: ODM
Similar models
Long Term Follow up Year 5
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
CL Item
Male (1)
CL Item
Female (2)
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])
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])
C0589121 (UMLS CUI [1,2])
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])
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])
C0062525 (UMLS CUI [1,2])
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
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])
C2349954 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
C0392360 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
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])
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
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])
C0600091 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
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])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
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])
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])
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])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Last seen
Item
Date of Contact
date
C0805839 (UMLS CUI [1])