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ID

33096

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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

Nyckelord

Versioner (1)
  1. 2018-11-27 2018-11-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

27 november 2018

DOI

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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

    Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Dose Number
    Beskrivning

    Dose Number

    Datatyp

    text

    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    integer

    Please do not forget to bring back the diary card on
    Beskrivning

    fill the date below

    Datatyp

    date

    In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
    Beskrivning

    If rash occurs, please also record the event below

    Datatyp

    text

    Rash Episode
    Beskrivning

    Rash Episode

    Rash Episode Number
    Beskrivning

    Rash Episode Number

    Datatyp

    integer

    Description
    Beskrivning

    Description

    Datatyp

    text

    Vaccination site
    Beskrivning

    Vaccination site

    Datatyp

    text

    Date Started
    Beskrivning

    Date Started

    Datatyp

    date

    Date Stopped
    Beskrivning

    Date Stopped

    Datatyp

    date

    Intensity
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    Intensity

    Datatyp

    text

    Temperature
    Beskrivning

    Temperature

    Datatyp

    text

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    Diary Card: Rash/Exanthem + Parotid/Salivary gland swelling + Febrile Convulsions

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    Item
    Dose Number
    text
    Dose Number
    Code List
    Dose Number
    CL Item
    Dose 1 (1)
    Subject Number
    Item
    Subject Number
    integer
    Please do not forget to bring back the diary card on
    Item
    Please do not forget to bring back the diary card on
    date
    In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
    Item
    In case rash/exanthem or Parotid/Salivary gland swelling or Febrile convulsions (suspected signs of meningism) is observed, bring the child to visit the investigators for clinical examination.
    text
    Item Group
    Rash Episode
    Item
    Rash Episode Number
    integer
    Rash Episode Number
    Code List
    Rash Episode Number
    CL Item
    RA 1 (1)
    CL Item
    RA 2 (2)
    CL Item
    RA 3 (3)
    Description
    Item
    Description
    text
    Item
    Vaccination site
    text
    Vaccination site
    Code List
    Vaccination site
    CL Item
    Left arm (1)
    CL Item
    Right arm (2)
    CL Item
    Non-administration site (3)
    Date Started
    Item
    Date Started
    date
    Date Stopped
    Item
    Date Stopped
    date
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    1-50 lesions (1)
    CL Item
    51-150 lesions (2)
    CL Item
    >150 lesions (3)
    Item
    Temperature
    text
    Temperature
    Code List
    Temperature
    CL Item
    Please complete the Temperature diary card (1)
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