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25395

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Phase A - Year 2 Extension - Telephone contact 29 - 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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Versioner (1)
  1. 02/09/2017 02/09/2017 -
Rättsinnehavare

glaxoSmithKline

Uppladdad den

2 de setembro de 2017

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Creative Commons BY-NC 3.0
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    Phase A - Year 2 Extension - Telephone contact 29 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    Engelsk

    Phase A - Year 2 Extension - Telephone contact 29 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 Formulär  
    Subject's contact
    Beskrivning

    Subject's contact

    Alias
    UMLS CUI-1
    C0332158
    UMLS CUI-2
    C0681850
    Was the subject successfully contacted at scheduled Telephone Contact 29?
    Beskrivning

    telephone contact

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0420309
    Has the subject been seen or contacted between the previous contact and this contact?
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0332158
    UMLS CUI [1,2]
    C0681850
    Last date
    Beskrivning

    Date of last contact

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0805839
    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 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 the previous contact and this contact?
    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
    Serious adverse event
    Beskrivning

    Serious adverse event

    Alias
    UMLS CUI-1
    C1519255
    Did the subject experience any serious adverse event between the previous contact and this contact?
    Beskrivning

    If 'yes, please complete the Serious Adverse Event form.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1519255
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    Similar models

    Phase A - Year 2 Extension - Telephone contact 29 - 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
    Subject's contact
    C0332158 (UMLS CUI-1)
    C0681850 (UMLS CUI-2)
    Item
    Was the subject successfully contacted at scheduled Telephone Contact 29?
    integer
    C0420309 (UMLS CUI [1])
    telephone contact
    Code List
    Was the subject successfully contacted at scheduled Telephone Contact 29?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA: Not applicable, please complete if there is no need to perform this telephone contact due to the end of Phase A. (3)
    contact with subject
    Item
    Has the subject been seen or contacted between the previous contact and this contact?
    boolean
    C0332158 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Date of last contact
    Item
    Last date
    date
    C0805839 (UMLS CUI [1])
    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 between the previous contact and this 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 the previous contact and this contact?
    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])
    Item Group
    Serious adverse event
    C1519255 (UMLS CUI-1)
    serious adverse event
    Item
    Did the subject experience any serious adverse event between the previous contact and this contact?
    boolean
    C1519255 (UMLS CUI [1])
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