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33068

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Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella CRF Seiten: 268-336; 870-938

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  1. 11/26/18 11/26/18 -
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GSK group of companies

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November 26, 2018

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Creative Commons BY-NC 3.0
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    Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

    Engelsk

    Febrile Convulsions AE Form

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    integer

    Febrile Convulsions - Suspected Signs of Meningitis
    Beskrivning

    Febrile Convulsions - Suspected Signs of Meningitis

    Event Number
    Beskrivning

    Please report any febrile convulsion and any suspected signs of meningitis occurring during the study period

    Datatyp

    integer

    Description
    Beskrivning

    Description

    Datatyp

    text

    Further Details (For GSK)
    Beskrivning

    Further Details (For GSK)

    Event Number
    Beskrivning

    Event Number

    Datatyp

    text

    Date started
    Beskrivning

    Date started

    Datatyp

    date

    Date stopped
    Beskrivning

    Date stopped

    Datatyp

    date

    Intensity
    Beskrivning

    Intensity

    Datatyp

    text

    Was a neurological examination performed?
    Beskrivning

    Was a neurological examination performed?

    Datatyp

    boolean

    If Yes, was a lumbar puncture performed?
    Beskrivning

    If Yes, was a lumbar puncture performed?

    Datatyp

    boolean

    If Yes, date of exam
    Beskrivning

    If Yes, date of exam

    Datatyp

    date

    Relationship to investigational products
    Beskrivning

    Relationship to investigational products

    Datatyp

    boolean

    Outcome
    Beskrivning

    Outcome

    Datatyp

    text

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    Febrile Convulsions AE Form

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Febrile Convulsions - Suspected Signs of Meningitis
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    FC. 1 (1)
    CL Item
    FC. 2 (2)
    Description
    Item
    Description
    text
    Item Group
    Further Details (For GSK)
    Item
    Event Number
    text
    Event Number
    Code List
    Event Number
    CL Item
    FC. 1 (1)
    CL Item
    FC. 2 (2)
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Was a neurological examination performed?
    Item
    Was a neurological examination performed?
    boolean
    If Yes, was a lumbar puncture performed?
    Item
    If Yes, was a lumbar puncture performed?
    boolean
    If Yes, date of exam
    Item
    If Yes, date of exam
    date
    Relationship to investigational products
    Item
    Relationship to investigational products
    boolean
    Item
    Outcome
    text
    Outcome
    Code List
    Outcome
    CL Item
    Recovered/resolved (1)
    CL Item
    Recovering/resolving (2)
    CL Item
    Not recovered/not resolved (3)
    CL Item
    Recovered with sequelae/resolved with sequelae (4)
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