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25375

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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 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. 02.09.17 02.09.17 -
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glaxoSmithKline

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2. September 2017

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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

    Englisch

    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 Formulare  
    Check for study continuation
    Beschreibung

    Check for study continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C0042210
    Did the subject return for visit 5?
    Beschreibung

    study continuation

    Datentyp

    integer

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

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

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348568
    SAE No
    Beschreibung

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

    Datentyp

    integer

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

    number of unsolicited adverse event

    Datentyp

    integer

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

    solicited AE code

    Datentyp

    text

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

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

    Datentyp

    text

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

    decision for study withdrawal

    Datentyp

    text

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

    Laboratory tests

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

    Blood sample

    Datentyp

    integer

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

    Please complete only if different from visit date

    Datentyp

    boolean

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

    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?
    Beschreibung

    Exposure in household to varicella/zoster

    Datentyp

    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
    Beschreibung

    Household exposure number

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

    Household Exposure No

    Datentyp

    integer

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

    Date of onset exposure

    Datentyp

    date

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

    Type of exposure

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0332157
    Varicella or zoster
    Beschreibung

    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 ?
    Beschreibung

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

    Datentyp

    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?
    Beschreibung

    Number of episodes of varicella/zoster signs and symptoms

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C0740380
    UMLS CUI [2,1]
    C0037088
    UMLS CUI [2,2]
    C0008049
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    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 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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])
    Zum Seitenanfang zurückkehren 

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