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ID

33066

Description

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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Versions (2)
  1. 11/23/18 11/23/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

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

    English

    Visit 2: Solicited Adverse Events (All Groups)

    1 forms  
    Administrative data
    Description

    Administrative data

    Visit Number
    Description

    Visit Number

    Data type

    text

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Local Symptoms
    Description

    Local Symptoms

    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Description

    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

    Data type

    text

    Local Symptoms
    Description

    Local Symptoms

    Redness
    Description

    If YES is ticked, please complete all items

    Data type

    boolean

    Size - Day 0
    Description

    Size - Day 0

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 1
    Description

    Size - Day 1

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 2
    Description

    Size - Day 2

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 3
    Description

    Size - Day 3

    Data type

    float

    Measurement units
    • mm
    mm
    Ongoing after Day 3?
    Description

    Ongoing after Day 3?

    Data type

    boolean

    If YES, record date of last day of symptoms
    Description

    If YES, record date of last day of symptoms

    Data type

    date

    Local Symptoms
    Description

    Local Symptoms

    Swelling
    Description

    If YES is ticked, please complete all items

    Data type

    boolean

    Size - Day 0
    Description

    Size - Day 0

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 1
    Description

    Size - Day 1

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 2
    Description

    Size - Day 2

    Data type

    float

    Measurement units
    • mm
    mm
    Size - Day 3
    Description

    Size - Day 3

    Data type

    float

    Measurement units
    • mm
    mm
    Ongoing after Day 3?
    Description

    Ongoing after Day 3?

    Data type

    boolean

    If YES, record date of last day of symptoms
    Description

    If YES, record date of last day of symptoms

    Data type

    date

    Local Symptoms
    Description

    Local Symptoms

    Pain
    Description

    If YES is ticked, please complete all items

    Data type

    boolean

    Intensity - Day 0
    Description

    Intensity - Day 0

    Data type

    integer

    Intensity - Day 1
    Description

    Intensity - Day 1

    Data type

    integer

    Intensity - Day 2
    Description

    Intensity - Day 2

    Data type

    integer

    Intensity - Day 3
    Description

    Intensity - Day 3

    Data type

    integer

    Ongoing after Day 3?
    Description

    Ongoing after Day 3?

    Data type

    boolean

    If YES, record date of last day of symptoms
    Description

    If YES, record date of last day of symptoms

    Data type

    date

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    Similar models

    Visit 2: Solicited Adverse Events (All Groups)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Item
    Visit Number
    text
    Visit Number
    Code List
    Visit Number
    CL Item
    Visit 2 (1)
    Date of Visit
    Item
    Date of Visit
    date
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    Local Symptoms
    Item
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    text
    Has the subject experienced any serious or non-serious unsolicited adverse events within minimum 43 days post-vaccination?
    Code List
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    CL Item
    Information not available (1)
    CL Item
    No vaccine administered (2)
    CL Item
    No (3)
    CL Item
    Yes, please tick NO/YES for each symptom.  (4)
    Item Group
    Local Symptoms
    Redness
    Item
    Redness
    boolean
    Size - Day 0
    Item
    Size - Day 0
    float
    Size - Day 1
    Item
    Size - Day 1
    float
    Size - Day 2
    Item
    Size - Day 2
    float
    Size - Day 3
    Item
    Size - Day 3
    float
    Ongoing after Day 3?
    Item
    Ongoing after Day 3?
    boolean
    If YES, record date of last day of symptoms
    Item
    If YES, record date of last day of symptoms
    date
    Item Group
    Local Symptoms
    Swelling
    Item
    Swelling
    boolean
    Size - Day 0
    Item
    Size - Day 0
    float
    Size - Day 1
    Item
    Size - Day 1
    float
    Size - Day 2
    Item
    Size - Day 2
    float
    Size - Day 3
    Item
    Size - Day 3
    float
    Ongoing after Day 3?
    Item
    Ongoing after Day 3?
    boolean
    If YES, record date of last day of symptoms
    Item
    If YES, record date of last day of symptoms
    date
    Item Group
    Local Symptoms
    Pain
    Item
    Pain
    boolean
    Item
    Intensity - Day 0
    integer
    Intensity - Day 0
    Code List
    Intensity - Day 0
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Item
    Intensity - Day 1
    integer
    Intensity - Day 1
    Code List
    Intensity - Day 1
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Item
    Intensity - Day 2
    integer
    Intensity - Day 2
    Code List
    Intensity - Day 2
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Item
    Intensity - Day 3
    integer
    Intensity - Day 3
    Code List
    Intensity - Day 3
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Ongoing after Day 3?
    Item
    Ongoing after Day 3?
    boolean
    If YES, record date of last day of symptoms
    Item
    If YES, record date of last day of symptoms
    date
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