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33061

Descrizione

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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versioni (1)
  1. 26/11/18 26/11/18 -
Titolare del copyright

GSK group of companies

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26 novembre 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

    Inglese

    Parotid / Salivary Gland Swelling AE Form

    1 moduli  
    Administrative data
    Descrizione

    Administrative data

    Subject Number
    Descrizione

    Subject Number

    Tipo di dati

    integer

    Parotid/Salivary Gland Swelling Events
    Descrizione

    Parotid/Salivary Gland Swelling Events

    Event Number
    Descrizione

    Please report any parotid / salivary gland swelling events occurring during the study period

    Tipo di dati

    integer

    Description
    Descrizione

    Description

    Tipo di dati

    text

    Further Details (For GSK)
    Descrizione

    Further Details (For GSK)

    Event Number
    Descrizione

    Event Number

    Tipo di dati

    integer

    Date started
    Descrizione

    Date started

    Tipo di dati

    date

    Date stopped
    Descrizione

    Date stopped

    Tipo di dati

    date

    Intensity
    Descrizione

    Intensity

    Tipo di dati

    text

    Saliva Sample
    Descrizione

    Saliva Sample

    Event Number
    Descrizione

    Event Number

    Tipo di dati

    integer

    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
    Descrizione

    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?

    Tipo di dati

    boolean

    If Yes, record date
    Descrizione

    If Yes, record date

    Tipo di dati

    date

    Relationship to Investigational products
    Descrizione

    Relationship to Investigational products

    Event Number
    Descrizione

    Event Number

    Tipo di dati

    integer

    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Descrizione

    Is there a reasonable possibility that the AE may have been caused by the investigational product?

    Tipo di dati

    boolean

    Outcome
    Descrizione

    Outcome

    Event Number
    Descrizione

    Event Number

    Tipo di dati

    integer

    Outcome
    Descrizione

    Outcome

    Tipo di dati

    text

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    Similar models

    Parotid / Salivary Gland Swelling AE Form

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Parotid/Salivary Gland Swelling Events
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    PS. 1 (1)
    CL Item
    PS. 2 (2)
    Description
    Item
    Description
    text
    Item Group
    Further Details (For GSK)
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    PS. 1 (1)
    CL Item
    PS. 2 (2)
    Date started
    Item
    Date started
    date
    Date stopped
    Item
    Date stopped
    date
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    Swelling without difficulties to move the jaw (1)
    CL Item
    Swelling with difficulties to move the jaw (2)
    CL Item
    Swelling and additional general symptoms (3)
    Item Group
    Saliva Sample
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    PS. 1 (1)
    CL Item
    PS. 2 (2)
    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
    Item
    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
    boolean
    If Yes, record date
    Item
    If Yes, record date
    date
    Item Group
    Relationship to Investigational products
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    PS. 1 (1)
    CL Item
    PS. 2 (2)
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    Item Group
    Outcome
    Item
    Event Number
    integer
    Event Number
    Code List
    Event Number
    CL Item
    PS. 1 (1)
    CL Item
    PS. 2 (2)
    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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