0 Beoordelingen
ID

33061

Beschrijving

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

Trefwoorden

Versies (1)
  1. 26-11-18 26-11-18 -
Houder van rechten

GSK group of companies

Geüploaded op

26 november 2018

DOI

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Licentie

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

    Engels

    Parotid / Salivary Gland Swelling AE Form

    1 Formulieren  
    Administrative data
    Beschrijving

    Administrative data

    Subject Number
    Beschrijving

    Subject Number

    Datatype

    integer

    Parotid/Salivary Gland Swelling Events
    Beschrijving

    Parotid/Salivary Gland Swelling Events

    Event Number
    Beschrijving

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

    Datatype

    integer

    Description
    Beschrijving

    Description

    Datatype

    text

    Further Details (For GSK)
    Beschrijving

    Further Details (For GSK)

    Event Number
    Beschrijving

    Event Number

    Datatype

    integer

    Date started
    Beschrijving

    Date started

    Datatype

    date

    Date stopped
    Beschrijving

    Date stopped

    Datatype

    date

    Intensity
    Beschrijving

    Intensity

    Datatype

    text

    Saliva Sample
    Beschrijving

    Saliva Sample

    Event Number
    Beschrijving

    Event Number

    Datatype

    integer

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

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

    Datatype

    boolean

    If Yes, record date
    Beschrijving

    If Yes, record date

    Datatype

    date

    Relationship to Investigational products
    Beschrijving

    Relationship to Investigational products

    Event Number
    Beschrijving

    Event Number

    Datatype

    integer

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

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

    Datatype

    boolean

    Outcome
    Beschrijving

    Outcome

    Event Number
    Beschrijving

    Event Number

    Datatype

    integer

    Outcome
    Beschrijving

    Outcome

    Datatype

    text

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    Similar models

    Parotid / Salivary Gland Swelling AE Form

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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