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ID

33097

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

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Versions (1)
  1. 11/27/18 11/27/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 27, 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

    Diary Card: Local Symptoms - Dose 2

    1 forms  
    Administrative data
    Description

    Administrative data

    Dose Number
    Description

    Dose Number

    Data type

    text

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Local Symptoms (at injection site)
    Description

    Local Symptoms (at injection site)

    please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
    Description

    please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter

    Data type

    text

    Local Symptoms
    Description

    Local Symptoms

    Day
    Description

    Day

    Data type

    integer

    Redness
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Swelling
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Pain
    Description

    intensity; please measure the greatest diameter

    Data type

    text

    Ongoing after Day 3?
    Description

    Ongoing after Day 3?

    Data type

    boolean

    If Yes, record the date of last day of symptoms
    Description

    If Yes, record the date of last day of symptoms

    Data type

    date

    Local Symptoms (Group Priorix)
    Description

    Local Symptoms (Group Priorix)

    Day
    Description

    Day

    Data type

    integer

    Redness
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Swelling
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Pain
    Description

    intensity

    Data type

    integer

    Ongoing after Day 3
    Description

    Ongoing after Day 3

    Data type

    boolean

    If Yes, date of last day of symptoms
    Description

    If Yes, date of last day of symptoms

    Data type

    date

    for investigator only (Priorix vaccine)
    Description

    for investigator only (Priorix vaccine)

    Side
    Description

    Side

    Data type

    text

    Site
    Description

    Site

    Data type

    text

    Local Symptoms (Group Varilrix)
    Description

    Local Symptoms (Group Varilrix)

    Day
    Description

    Day

    Data type

    integer

    Redness
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Swelling
    Description

    size

    Data type

    float

    Measurement units
    • mm
    mm
    Pain
    Description

    intensity

    Data type

    integer

    Ongoing after day 3?
    Description

    Ongoing after day 3?

    Data type

    boolean

    If Yes, record the date of last day of symptoms
    Description

    If Yes, record the date of last day of symptoms

    Data type

    date

    for investigator only (Varilrix vaccine)
    Description

    for investigator only (Varilrix vaccine)

    Side
    Description

    Side

    Data type

    integer

    Site
    Description

    Site

    Data type

    integer

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    Diary Card: Local Symptoms - Dose 2

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
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    Dose Number
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    Item Group
    Local Symptoms (at injection site)
    please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
    Item
    please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed hereafter
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    Item Group
    Local Symptoms
    Item
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    Ongoing after Day 3?
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    Item
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    date
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    Item
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    Minor reaction to touch (2)
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    Cries/protests on touch (3)
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    Cries when limb is moved/spontaneously painful (4)
    Ongoing after Day 3
    Item
    Ongoing after Day 3
    boolean
    If Yes, date of last day of symptoms
    Item
    If Yes, date of last day of symptoms
    date
    Item Group
    for investigator only (Priorix vaccine)
    Item
    Side
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    Side
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    CL Item
    Lower left (2)
    CL Item
    Upper right (3)
    CL Item
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    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
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    Local Symptoms (Group Varilrix)
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (Evening) (2)
    CL Item
    Day 2 (Evening) (3)
    CL Item
    Day 3 (Evening) (4)
    Redness
    Item
    Redness
    float
    Swelling
    Item
    Swelling
    float
    Item
    Pain
    integer
    Pain
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    Pain
    CL Item
    Absent (1)
    CL Item
    Minor reaction to touch (2)
    CL Item
    Cries/protests on touch (3)
    CL Item
    Cries when limb is moved/spontaneously painful (4)
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    Ongoing after day 3?
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    Upper right (3)
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    Lower right (4)
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    Thigh (2)
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