ID

25110

Beskrivning

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Study conclusion - Phase A Active 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. 2017-08-26 2017-08-26 -
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glaxoSmithKline

Uppladdad den

26 augusti 2017

DOI

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

Engelsk

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Study conclusion - Phase A Active

1 Formulär  
Occurrence of serious adverse event
Beskrivning

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event during the study "Phase A Active"?
Beskrivning

Serious adverse event

Datatyp

boolean

Alias
UMLS CUI [1]
C1519255
Specify total number of SAE's
Beskrivning

Only answer if you chose 'yes'a s previous answer.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Status of treatment blind
Beskrivning

Status of treatment blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken during the study "Phase A Active"?
Beskrivning

treatment blind broken

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2347038
UMLS CUI [1,2]
C0449438
Complete date treatment blind was broken.
Beskrivning

Date treatment blind broken

Datatyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Reason for breaking treatment blind
Beskrivning

Reason treatment blind broken

Datatyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Please specify other reason for breaking treatment blind.
Beskrivning

Specify other reason for unblinding

Datatyp

text

Alias
UMLS CUI [1,1]
C2826259
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Elimination criteria
Beskrivning

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable during the study "Phase A Active"?
Beskrivning

Elimination criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
Specify elimination criteria
Beskrivning

Only answer if you chose 'yes' as previous answer.

Datatyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Was the subject withdrawn from the study "Phase A Active"?
Beskrivning

study subject participation status withdrawn

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0422727
Please tick the ONE most appropriate category for withdrawal.
Beskrivning

Reason for withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
Please specify SAE No
Beskrivning

Number of serious adverse events

Datatyp

integer

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

Number of unsolicited adverse events

Datatyp

integer

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

solicited adverse event code

Datatyp

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1521902
Please specify protocol violation
Beskrivning

specify protocol violation

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C1521902
Please specify other reason for study withdrawal
Beskrivning

other reason for withdrawal

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision
Beskrivning

Decision

Datatyp

text

Alias
UMLS CUI [1]
C0679006
Date of last contact
Beskrivning

Date of last contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact?
Beskrivning

Condition last contact

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
Please specify your concerns about study subject's condition.
Beskrivning

Only fill in, if you answered previous question with 'no'.

Datatyp

text

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0681850
UMLS CUI [1,3]
C1521902
Subject's contact
Beskrivning

Subject's contact

Alias
UMLS CUI-1
C0332158
UMLS CUI-2
C0681850
Was the subject contacted between the previous scheduled contact/visit and this study conclusion ?
Beskrivning

Contact with study subject between visits

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
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 between the previous contact and this study conclusion ?
Beskrivning

Household exposure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
Household Exposure
Beskrivning

Household Exposure

Alias
UMLS CUI-1
C0332157
UMLS CUI-2
C0020052
Household exposure No.
Beskrivning

Household exposure number

Datatyp

integer

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

date of exposure

Datatyp

date

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0020052
UMLS CUI [1,3]
C0011008
Type of exposure
Beskrivning

Type of exposure

Datatyp

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0332307
Varicella or Zoster
Beskrivning

Varicella or Zoster

Alias
UMLS CUI-1
C0008049
UMLS CUI-2
C0740380
Did the subject present any signs of varicella or zoster symptoms between the previous contact and this study conclusion ?
Beskrivning

Signs and symptoms varicella or zoster

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0008049
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0740380
How many episodes of symptoms of varicella or zoster?
Beskrivning

episodes of varicella or zoster

Datatyp

integer

Alias
UMLS CUI [1,1]
C4086638
UMLS CUI [1,2]
C0008049
UMLS CUI [2,1]
C4086638
UMLS CUI [2,2]
C0740380
Investigator's signature
Beskrivning

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Beskrivning

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.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Investigator's signature date
Beskrivning

Date of investigator's signature

Datatyp

date

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

Investigator name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
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Similar models

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Study conclusion - Phase A Active

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study "Phase A Active"?
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])
Item Group
Status of treatment blind
C2347038 (UMLS CUI-1)
C0449438 (UMLS CUI-2)
treatment blind broken
Item
Was the treatment blind broken during the study "Phase A Active"?
boolean
C2347038 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Date treatment blind broken
Item
Complete date treatment blind was broken.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Reason for breaking treatment blind
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason treatment blind broken
Code List
Reason for breaking treatment blind
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other, specify (2)
Specify other reason for unblinding
Item
Please specify other reason for breaking treatment blind.
text
C2826259 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable during the study "Phase A Active"?
boolean
C0680251 (UMLS CUI [1])
Specify elimination criteria
Item
Specify elimination criteria
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
study subject participation status withdrawn
Item
Was the subject withdrawn from the study "Phase A Active"?
boolean
C2348568 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate category for withdrawal.
text
C0422727 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for withdrawal
Code List
Please tick the ONE most appropriate category for withdrawal.
CL Item
Serious adverse event (check Serious Adverse Event form) (SAE)
CL Item
Non-serious adverse event (check the Non-serious Adverse Event section) (AEX)
CL Item
Protocol violation (PTV)
CL Item
Consent withdrawal, not due to an adverse event. (CWS)
CL Item
Migrated / moved from the study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Other, please specify (e.g. non-serious AE for non-subset) (OTH)
Number of serious adverse events
Item
Please specify SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Number of unsolicited adverse events
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
solicited adverse event code
Item
Please specify solicited AE code
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
specify protocol violation
Item
Please specify protocol violation
text
C1709750 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
other reason for withdrawal
Item
Please specify other reason for study withdrawal
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1])
Decision
Code List
Please tick who took the decision
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Condition last contact
Item
Was the subject in good condition at date of last contact?
boolean
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Specify study subjects condition
Item
Please specify your concerns about study subject's condition.
text
C1142435 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item Group
Subject's contact
C0332158 (UMLS CUI-1)
C0681850 (UMLS CUI-2)
Contact with study subject between visits
Item
Was the subject contacted between the previous scheduled contact/visit and this study conclusion ?
boolean
C0332158 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Item Group
Household exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Household exposure
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 between the previous contact and this study conclusion ?
boolean
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
Item Group
Household Exposure
C0332157 (UMLS CUI-1)
C0020052 (UMLS CUI-2)
Household exposure number
Item
Household exposure No.
integer
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
date of exposure
Item
Date of the exposure
date
C0332157 (UMLS CUI [1,1])
C0020052 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Type of exposure
integer
C0332157 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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-2)
Signs and symptoms varicella or zoster
Item
Did the subject present any signs of varicella or zoster symptoms between the previous contact and this study conclusion ?
boolean
C0037088 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C0037088 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
episodes of varicella or zoster
Item
How many episodes of symptoms of varicella or zoster?
integer
C4086638 (UMLS CUI [1,1])
C0008049 (UMLS CUI [1,2])
C4086638 (UMLS CUI [2,1])
C0740380 (UMLS CUI [2,2])
Item Group
Investigator's signature
C2346576 (UMLS CUI-1)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of investigator's signature
Item
Investigator's 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])
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