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ID
26642
Beschreibung
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
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Versionen (1)
- 23.10.17 23.10.17 -
Rechteinhaber
Glaxo Smith Kline
Hochgeladen am
23. Oktober 2017
DOI
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Creative Commons BY-NC 3.0
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GSK Study ID 100386 & 100387 Persistence of immune response to TWINRIX™ ADULT Additional Vaccination Year 6- Long Term Follow up and Study conclusion
Additional Vaccination Year 6- Long Term Follow up and Study conclusion
Ähnliche Modelle
Additional Vaccination Year 6- Long Term Follow up and Study conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Long Term Follow up Visit 10
C0042196 (UMLS CUI-1)
C0940824 (UMLS CUI-2)
C0940824 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Did the subject come at visit 9?
Item
Did the subject come at visit 9?
boolean
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Same reason and decision as previous visit.
Item
Same reason and decision as previous visit.
boolean
C2348568 (UMLS CUI [1,1])
C2127115 (UMLS CUI [1,2])
C2127115 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (2)
CL Item
Other please specify (3)
Item
Please specify SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
unsolicited AE number
Item
Please specify unsolicited AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
solicited AE code
Item
Please specify solicited AE code
integer
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other specify
Item
If other please specify
text
C3845569 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Subject (S)
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Sample Collection Date
Item
Sample Collection Date
date
C1302413 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Concomitant Vaccination
Item
Has any vaccine other than the study vaccine(s) been administered since Visit 8?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI-2)
Trade name of vaccine
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration Date
Item
Administration Date
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Concomitant medications
Item
Have any medications/treatments been administered since Visit 8?
boolean
C2347852 (UMLS CUI [1])
Trade name of medication
Item
Trade / Generic name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Medical indication for medication
Item
Medical indication
text
C2826696 (UMLS CUI [1])
Medical Indication
Item
Medical Indication: Prophylactic
boolean
C0199176 (UMLS CUI [1,1])
C2826696 (UMLS CUI [1,2])
C2826696 (UMLS CUI [1,2])
Total Daily Dose
Item
Total Daily Dose
text
C2348070 (UMLS CUI [1])
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Concomitant Medication Start Date
Item
Start date
date
C2826734 (UMLS CUI [1])
concomitant medication end date
Item
End Date
date
C2826744 (UMLS CUI [1])
Continuing at end of study
Item
Continuing at end of Study?
boolean
C2826666 (UMLS CUI [1,1])
C0444496 (UMLS CUI [1,2])
C0444496 (UMLS CUI [1,2])
non-serious adverse events post-vaccination
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C0042196 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0700325 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
Adverse Event Number
Item
Adverse Event Number
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
Adverse Event Description
Item
Adverse Event Description
text
C0877248 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,2])
CL Item
Administration site (L)
CL Item
Non-administration site (G)
AE start date
Item
Date Started
date
C2697888 (UMLS CUI [1])
Immediate AE start
Item
AE start during immediate post-vaccination period (30 minutes)
text
C0877248 (UMLS CUI [1,1])
C0205253 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,2])
AE End date
Item
Date Stopped
date
C2697886 (UMLS CUI [1])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event during the study period?
boolean
C1519255 (UMLS CUI [1])
number of serious adverse events
Item
Specify total number of SAE´s
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,2])
CL Item
No (1)
CL Item
Yes (Complete the Pregnancy Notification form) (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Study Withdrawal
Item
Was the subject withdrawn from the study?
boolean
C0422727 (UMLS CUI [1])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
CL Item
Non-serious adverse event (check the Non-serious Adverse Event section) (AEX)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Lost to follow-up (LFU)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Other, please specify (OTH)
CL Item
Protocol violation (PTV)
CL Item
Serious adverse event (check Serious Adverse Event form) (SAE)
serious adverse events
Item
Please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Please specify unsolicited AE No
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Please specify solicited AE code
Item
Please specify solicited AE code
integer
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Item
Please tick who took decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Investigator (I)
CL Item
Subject (S)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject in good condition at date of last contact?
integer
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
CL Item
No, please give details within the Adverse Events section (1)
CL Item
Yes (2)
Investigators signature
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
C2346576 (UMLS CUI [1])
Investigators signature
Item
Investigators signature
text
C2346576 (UMLS CUI [1])
Investigator name
Item
Printed Investigators name
text
C2826892 (UMLS CUI [1])
Date of completion
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0850287 (UMLS CUI [1,2])
C0850287 (UMLS CUI [1,2])