ID

24019

Beskrivning

Study ID: 101377 Clinical Study ID: 101377 Study Title: A phase III, open, randomized, multicentre study to demonstrate the non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine according to a 0-1-6 month schedule, to the monovalent hepatitis A vaccine Havrix and hepatitis B vaccine Engerix separately administered, in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: 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 Documentation part: Visit 4, Month 7 (30 - 40 Days after Visit 3)

Nyckelord

Versioner (1)
  1. 23.07.17 23.07.17 -
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23. Juli 2017

DOI

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Creative Commons BY-NC 3.0
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Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults Visit 4 101377

Engelsk

Visit 4 Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulär  
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject come at visit 4?
Beskrivning

subject return for visit

Datatyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

If No, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Beskrivning

If Serious adverse event, please specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Beskrivning

If Other, please specify

Datatyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Beskrivning

reason for study discontinuation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Laboratory Tests
Beskrivning

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0430056
UMLS CUI-4
C0042210
Has a blood sample been taken?
Beskrivning

blood sample

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beskrivning

Please complete only if different from visit date:

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 4 Non-inferiority of GSK Biologicals' combined hepatitis A and hepatitis B vaccine to Havrix and Engerix in healthy adults 101377

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject come at visit 4?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject come at visit 4?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (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])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Non serious adverse Event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0430056 (UMLS CUI-3)
C0042210 (UMLS CUI-4)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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