ID

25375

Beskrivning

Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Nyckelord

Versioner (1)
  1. 2017-09-02 2017-09-02 -
Rättsinnehavare

glaxoSmithKline

Uppladdad den

2 september 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

Engelsk

Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

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 return for visit 5?
Beskrivning

study continuation

Datatyp

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Why didn't the subject return to visit 5?
Beskrivning

Please tick the ONE most appropriate reason and skip the following pages of this visit

Datatyp

text

Alias
UMLS CUI [1]
C2348568
SAE No
Beskrivning

Please specify number of SAE if that is the reason, why subject didn't return to visit 2.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Beskrivning

number of unsolicited adverse event

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
solicited AE code
Beskrivning

solicited AE code

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for not returning to visit 5.
Beskrivning

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Datatyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Please tick who took the decision
Beskrivning

decision for study withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Laboratory tests
Beskrivning

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Beskrivning

Blood sample

Datatyp

integer

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Beskrivning

Please complete only if different from visit date

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Household exposure
Beskrivning

Household exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household since last contact?
Beskrivning

Exposure in household to varicella/zoster

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0020052
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0020052
Household exposure number
Beskrivning

Household exposure number

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
UMLS CUI-3
C0449788
Household Exposure No
Beskrivning

Household Exposure No

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
UMLS CUI [1,3]
C0449788
Date of onset exposure
Beskrivning

Date of onset exposure

Datatyp

date

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C0332157
Type of exposure
Beskrivning

Type of exposure

Datatyp

integer

Alias
UMLS CUI [1]
C0332157
Varicella or zoster
Beskrivning

Varicella or zoster

Alias
UMLS CUI-1
C0008049
UMLS CUI-3
C0740380
Did the subject present any signs of varicella or zoster symptoms between last contact and Visit 5 ?
Beskrivning

if 'yes', please complete the Varicella or Zoster Case section.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
How many episodes?
Beskrivning

Number of episodes of varicella/zoster signs and symptoms

Datatyp

integer

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0740380
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0008049
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Similar models

Phase A - Year 2 - Visit 5 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

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 return for visit 5?
integer
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
study continuation
Code List
Did the subject return for visit 5?
CL Item
Yes, please complete the next pages. (1)
CL Item
No (2)
Item
Why didn't the subject return to visit 5?
text
C2348568 (UMLS CUI [1])
Why didn't the subject return to visit 2?
Code List
Why didn't the subject return to visit 5?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
solicited AE code
Item
solicited AE code
text
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for not returning to visit 5.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
decision for study withdrawal
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents / Guardians (P)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken?
integer
C0005834 (UMLS CUI [1])
Blood sample
Code List
Has a blood sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Household exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Exposure in household to varicella/zoster
Item
Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household since last contact?
boolean
C0008049 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0020052 (UMLS CUI [1,3])
C0740380 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0020052 (UMLS CUI [2,3])
Item Group
Household exposure number
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
C0449788 (UMLS CUI-3)
Household Exposure No
Item
Household Exposure No
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
Date of onset exposure
Item
Date of onset exposure
date
C0574845 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1])
Type of exposure
Code List
Type of exposure
CL Item
Varicella (1)
CL Item
Zoster (2)
Item Group
Varicella or zoster
C0008049 (UMLS CUI-1)
C0740380 (UMLS CUI-3)
signs or symptoms of varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between last contact and Visit 5 ?
boolean
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
Number of episodes of varicella/zoster signs and symptoms
Item
How many episodes?
integer
C0037088 (UMLS CUI [1,1])
C0740380 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0008049 (UMLS CUI [2,2])
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