ID

25398

Description

Phase A - Year 2 - Concomitant Vaccination, Medication and Study Conclusion - 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

Keywords

Versions (1)
  1. 9/3/17 9/3/17 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 3, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Phase A - Year 2 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

English

Phase A - Year 2 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 forms  
Concomitant Vaccination
Description

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) been administered between Visit 4 and end of Phase A?
Description

If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date.

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant vaccination
Description

Concomitant vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade / (Generic) Name
Description

Trade name of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0042196
Route
Description

Administration route of vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Description

Vaccine administration date

Data type

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered between Visit 3 and Visit 4 according to protocol?
Description

Medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Trade / Generic name
Description

Trade name of medication

Data type

text

Alias
UMLS CUI [1,1]
C0592503
UMLS CUI [1,2]
C0013227
Medical indication
Description

Medical indication for medication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Prophylactic
Description

Prophylactic medication

Data type

boolean

Alias
UMLS CUI [1]
C0420172
Total daily dose
Description

Total daily dose

Data type

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Description

Route of administration

Data type

text

Alias
UMLS CUI [1]
C0013153
Start Date
Description

Start Date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

End Date of Medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Continuous medication
Description

Medication continuing

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Occurrence of serious adverse event
Description

Occurrence of serious adverse event

Alias
UMLS CUI-1
C1519255
Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
Description

Serious adverse event

Data type

boolean

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

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

Data type

integer

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

Status of treatment blind

Alias
UMLS CUI-1
C2347038
UMLS CUI-2
C0449438
Was the treatment blind broken between Visit 3 and Visit 4?
Description

treatment blind broken

Data type

boolean

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

Date treatment blind broken

Data type

date

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

Reason treatment blind broken

Data type

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Elimination criteria
Description

Elimination criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable between Visit 3 and Visit 4?
Description

Elimination criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Specify elimination criteria
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Was the subject withdrawn from the study "Phase A Year 2" and Extension Phase A?
Description

study subject participation status withdrawn

Data type

boolean

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

Reason for withdrawal

Data type

text

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

Number of serious adverse events

Data type

integer

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

Number of unsolicited adverse events

Data type

integer

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

solicited adverse event code

Data type

text

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

specify protocol violation

Data type

text

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

other reason for withdrawal

Data type

text

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

Decision

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2348568
Date of last contact
Description

Date of last contact

Data type

date

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

Condition last contact

Data type

boolean

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

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

Data type

text

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

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 ?
Description

Contact with study subject between visits

Data type

boolean

Alias
UMLS CUI [1,1]
C0332158
UMLS CUI [1,2]
C0681850
Household exposure
Description

Household exposure

Alias
UMLS CUI-1
C0020052
UMLS CUI-2
C0332157
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 ?
Description

Household exposure

Data type

boolean

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

Household Exposure

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

Household exposure number

Data type

integer

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

date of exposure

Data type

date

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

Type of exposure

Data type

integer

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

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 ?
Description

Signs and symptoms varicella or zoster

Data type

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?
Description

episodes of varicella or zoster

Data type

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
Description

Investigator's signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

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.

Data type

text

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

Date of investigator's signature

Data type

date

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

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Reason for non participation
Description

Reason for non participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Reason for non participation
Description

Reason for non participation

Data type

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
Please specify criteria for non-eligibility.
Description

Subject not eligible? - please specify criteria that are not fullfilled:

Data type

text

Alias
UMLS CUI [1,1]
C1555471
UMLS CUI [1,2]
C1521902
Subject eligible but not willing to participate due to: Please specify:
Description

Only fill in, if you chose "Subject eligible but not willing to participate due to: Please specify:" before.

Data type

text

Alias
UMLS CUI [1,1]
C3846156
UMLS CUI [1,2]
C0392360
Please specify serious adverse event which is the reason for the subject being not willing to participate
Description

Only fill in, if you chose "adverse events, or serious adverse event: please specify" before.

Data type

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C1521902
Please specify other reason for subject not willing to participate
Description

Only fill in if you chose "other" before.

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2348568
Date of death
Description

Only fill in, if you chose "Subject died on:" before.

Data type

date

Alias
UMLS CUI [1]
C1148348
Date of contact
Description

Date of contact

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
UMLS CUI [1,3]
C2348568
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Phase A - Year 2 - Concomitant Vaccination, Medication and Study Conclusion - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant vaccination
Item
Has any vaccine other than the study vaccine(s) been administered between Visit 4 and end of Phase A?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade name of vaccine
Item
Trade / (Generic) Name
text
C0592503 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Administration route of vaccine
Code List
Route
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)
Vaccine administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
Medication
Item
Have any medications/treatments been administered between Visit 3 and Visit 4 according to protocol?
boolean
C0013227 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade name of medication
Item
Trade / Generic name
text
C0592503 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medical indication for medication
Item
Medical indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Prophylactic medication
Item
Prophylactic
boolean
C0420172 (UMLS CUI [1])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1])
Route of administration
Code List
Route
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)
Start Date of medication
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of Medication
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication continuing
Item
Continuous medication
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item Group
Occurrence of serious adverse event
C1519255 (UMLS CUI-1)
Serious adverse event
Item
Did the subject experience any Serious Adverse Event between Visit 3 and Visit 4?
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 between Visit 3 and Visit 4?
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)
Item Group
Elimination criteria
C0680251 (UMLS CUI-1)
Elimination criteria
Item
Did any elimination criteria become applicable between Visit 3 and Visit 4?
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 Year 2" and Extension Phase A?
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 [1,1])
C2348568 (UMLS CUI [1,2])
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
C0020052 (UMLS CUI-1)
C0332157 (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
C0020052 (UMLS CUI-1)
C0332157 (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])
Item Group
Reason for non participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
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])
Reason for non participation
Code List
Reason for non participation
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: (3)
CL Item
Subject died on: (4)
specify criteria non eligible
Item
Please specify criteria for non-eligibility.
text
C1555471 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
not willing to participate
Item
Subject eligible but not willing to participate due to: Please specify:
text
C3846156 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
specify serious adverse event
Item
Please specify serious adverse event which is the reason for the subject being not willing to participate
text
C2348568 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
specify other reason
Item
Please specify other reason for subject not willing to participate
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
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