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ID

33470

Description

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

Versions (1)
  1. 12/10/18 12/10/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 10, 2018

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Creative Commons BY-NC 3.0
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    Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

    English

    Diary Card: Local Symptoms (Plain PRP followed by BTPw-HBV Kft)

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Visit
    Description

    Visit

    Data type

    text

    Protocol Number
    Description

    Protocol Number

    Data type

    integer

    Local Symptoms - Redness (at injection site)
    Description

    Local Symptoms - Redness (at injection site)

    Day
    Description

    Day

    Data type

    integer

    Size
    Description

    please measure the greatest diameter

    Data type

    integer

    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

    Medical attended visit?
    Description

    Medical attended visit?

    Data type

    boolean

    Local Symptoms - Swelling (at injection site)
    Description

    Local Symptoms - Swelling (at injection site)

    Day
    Description

    Day

    Data type

    integer

    Size
    Description

    please measure the greatest diameter

    Data type

    integer

    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

    Medical attended visit?
    Description

    Medical attended visit?

    Data type

    boolean

    Local Symptoms - Pain (at injection site)
    Description

    Local Symptoms - Pain (at injection site)

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    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

    Medically attended visit?
    Description

    Medically attended visit?

    Data type

    boolean

    Other Local Symptoms
    Description

    Other Local Symptoms

    Description
    Description

    please specify side(s) and site(s)

    Data type

    text

    Intensity
    Description

    Intensity

    Data type

    text

    Start date
    Description

    Start date

    Data type

    date

    End date
    Description

    End date

    Data type

    date

    Ongoing?
    Description

    Ongoing?

    Data type

    boolean

    Medically attended visit?
    Description

    Medically attended visit?

    Data type

    boolean

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    Similar models

    Diary Card: Local Symptoms (Plain PRP followed by BTPw-HBV Kft)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Item
    Visit
    text
    Visit
    Code List
    Visit
    CL Item
    Vaccination 1 (1)
    Protocol Number
    Item
    Protocol Number
    integer
    Item Group
    Local Symptoms - Redness (at injection site)
    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)
    Size
    Item
    Size
    integer
    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
    Medical attended visit?
    Item
    Medical attended visit?
    boolean
    Item Group
    Local Symptoms - Swelling (at injection site)
    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)
    Size
    Item
    Size
    integer
    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
    Medical attended visit?
    Item
    Medical attended visit?
    boolean
    Item Group
    Local Symptoms - Pain (at injection site)
    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)
    Item
    Intensity
    integer
    Intensity
    Code List
    Intensity
    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 date of last day of symptoms
    Item
    If Yes, record date of last day of symptoms
    date
    Medically attended visit?
    Item
    Medically attended visit?
    boolean
    Item Group
    Other Local Symptoms
    Description
    Item
    Description
    text
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    Mild (1)
    CL Item
    Moderate (2)
    CL Item
    Severe (3)
    Start date
    Item
    Start date
    date
    End date
    Item
    End date
    date
    Ongoing?
    Item
    Ongoing?
    boolean
    Medically attended visit?
    Item
    Medically attended visit?
    boolean
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