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25110

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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 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

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  1. 26-08-17 26-08-17 -
Titular dos direitos

glaxoSmithKline

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26 augustus 2017

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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

    Inglês

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

    1 Formulários  
    Occurrence of serious adverse event
    Descrição

    Occurrence of serious adverse event

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

    Serious adverse event

    Tipo de dados

    boolean

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

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

    Tipo de dados

    integer

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

    Status of treatment blind

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

    treatment blind broken

    Tipo de dados

    boolean

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

    Date treatment blind broken

    Tipo de dados

    date

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

    Reason treatment blind broken

    Tipo de dados

    integer

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

    Specify other reason for unblinding

    Tipo de dados

    text

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

    Elimination criteria

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

    Elimination criteria

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0680251
    Specify elimination criteria
    Descrição

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

    Tipo de dados

    text

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

    study subject participation status withdrawn

    Tipo de dados

    boolean

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

    Reason for withdrawal

    Tipo de dados

    text

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

    Number of serious adverse events

    Tipo de dados

    integer

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

    Number of unsolicited adverse events

    Tipo de dados

    integer

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

    solicited adverse event code

    Tipo de dados

    text

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

    specify protocol violation

    Tipo de dados

    text

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

    other reason for withdrawal

    Tipo de dados

    text

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

    Decision

    Tipo de dados

    text

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

    Date of last contact

    Tipo de dados

    date

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

    Condition last contact

    Tipo de dados

    boolean

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

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

    Tipo de dados

    text

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

    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 ?
    Descrição

    Contact with study subject between visits

    Tipo de dados

    boolean

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

    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 ?
    Descrição

    Household exposure

    Tipo de dados

    boolean

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

    Household Exposure

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

    Household exposure number

    Tipo de dados

    integer

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

    date of exposure

    Tipo de dados

    date

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

    Type of exposure

    Tipo de dados

    integer

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

    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 ?
    Descrição

    Signs and symptoms varicella or zoster

    Tipo de dados

    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?
    Descrição

    episodes of varicella or zoster

    Tipo de dados

    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
    Descrição

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Descrição

    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.

    Tipo de dados

    text

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

    Date of investigator's signature

    Tipo de dados

    date

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

    Investigator name

    Tipo de dados

    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 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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