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33097

Beschreibung

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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  1. 27.11.18 27.11.18 -
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GSK group of companies

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27. November 2018

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    Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

    Englisch

    Diary Card: Local Symptoms - Dose 2

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Dose Number
    Beschreibung

    Dose Number

    Datentyp

    text

    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Local Symptoms (at injection site)
    Beschreibung

    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
    Beschreibung

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

    Datentyp

    text

    Local Symptoms
    Beschreibung

    Local Symptoms

    Day
    Beschreibung

    Day

    Datentyp

    integer

    Redness
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Swelling
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Pain
    Beschreibung

    intensity; please measure the greatest diameter

    Datentyp

    text

    Ongoing after Day 3?
    Beschreibung

    Ongoing after Day 3?

    Datentyp

    boolean

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

    If Yes, record the date of last day of symptoms

    Datentyp

    date

    Local Symptoms (Group Priorix)
    Beschreibung

    Local Symptoms (Group Priorix)

    Day
    Beschreibung

    Day

    Datentyp

    integer

    Redness
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Swelling
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Pain
    Beschreibung

    intensity

    Datentyp

    integer

    Ongoing after Day 3
    Beschreibung

    Ongoing after Day 3

    Datentyp

    boolean

    If Yes, date of last day of symptoms
    Beschreibung

    If Yes, date of last day of symptoms

    Datentyp

    date

    for investigator only (Priorix vaccine)
    Beschreibung

    for investigator only (Priorix vaccine)

    Side
    Beschreibung

    Side

    Datentyp

    text

    Site
    Beschreibung

    Site

    Datentyp

    text

    Local Symptoms (Group Varilrix)
    Beschreibung

    Local Symptoms (Group Varilrix)

    Day
    Beschreibung

    Day

    Datentyp

    integer

    Redness
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Swelling
    Beschreibung

    size

    Datentyp

    float

    Maßeinheiten
    • mm
    mm
    Pain
    Beschreibung

    intensity

    Datentyp

    integer

    Ongoing after day 3?
    Beschreibung

    Ongoing after day 3?

    Datentyp

    boolean

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

    If Yes, record the date of last day of symptoms

    Datentyp

    date

    for investigator only (Varilrix vaccine)
    Beschreibung

    for investigator only (Varilrix vaccine)

    Side
    Beschreibung

    Side

    Datentyp

    integer

    Site
    Beschreibung

    Site

    Datentyp

    integer

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    Diary Card: Local Symptoms - Dose 2

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    Item
    Dose Number
    text
    Dose Number
    Code List
    Dose Number
    CL Item
    Dose 2 (1)
    Subject Number
    Item
    Subject Number
    integer
    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
    text
    Item Group
    Local Symptoms
    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
    text
    Pain
    Code List
    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)
    Ongoing after Day 3?
    Item
    Ongoing after Day 3?
    boolean
    If Yes, record the date of last day of symptoms
    Item
    If Yes, record the date of last day of symptoms
    date
    Item Group
    Local Symptoms (Group Priorix)
    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
    Code List
    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)
    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
    text
    Side
    Code List
    Side
    CL Item
    Upper left (1)
    CL Item
    Lower left (2)
    CL Item
    Upper right (3)
    CL Item
    Lower right (4)
    Item
    Site
    text
    Site
    Code List
    Site
    CL Item
    Arm (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item Group
    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
    Code List
    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)
    Ongoing after day 3?
    Item
    Ongoing after day 3?
    boolean
    If Yes, record the date of last day of symptoms
    Item
    If Yes, record the date of last day of symptoms
    date
    Item Group
    for investigator only (Varilrix vaccine)
    Item
    Side
    integer
    Side
    Code List
    Side
    CL Item
    Upper left (1)
    CL Item
    Lower left (2)
    CL Item
    Upper right (3)
    CL Item
    Lower right (4)
    Item
    Site
    integer
    Site
    Code List
    Site
    CL Item
    Arm (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
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