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ID

33342

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

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Versions (1)
  1. 12/6/18 12/6/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 6, 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

    Visit 3: Solicited Adverse Events

    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

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Solicited Adverse Events
    Description

    Solicited Adverse Events

    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 - Redness
    Description

    Local Symptoms - Redness

    Day
    Description

    Day

    Data type

    integer

    Redness
    Description

    Redness

    Data type

    boolean

    If Yes, record the size
    Description

    If Yes, record the size

    Data type

    integer

    Measurement units
    • mm
    mm
    Ongoing after day 7?
    Description

    Ongoing after day 7?

    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

    If Yes, record the visit type
    Description

    If Yes, record the visit type

    Data type

    text

    Local Symptoms - Swelling
    Description

    Local Symptoms - Swelling

    Day
    Description

    Day

    Data type

    integer

    Swelling
    Description

    Swelling

    Data type

    boolean

    If Yes, record the size
    Description

    If Yes, record the size

    Data type

    integer

    Measurement units
    • mm
    mm
    Ongoing after day 7?
    Description

    Ongoing after day 7?

    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

    If Yes, record the visit type
    Description

    If Yes, record the visit type

    Data type

    text

    Local Symptoms - Pain
    Description

    Local Symptoms - Pain

    Day
    Description

    Day

    Data type

    integer

    Pain
    Description

    Pain

    Data type

    boolean

    If Yes, record the intensity
    Description

    If Yes, record the intensity

    Data type

    text

    Ongoing after day 7?
    Description

    Ongoing after day 7?

    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

    If Yes, record the visit type
    Description

    If Yes, record the visit type

    Data type

    text

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    Similar models

    Visit 3: Solicited Adverse Events

    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 2 (1)
    Protocol Number
    Item
    Protocol Number
    integer
    Date of Visit
    Item
    Date of Visit
    date
    Item Group
    Solicited Adverse Events
    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 of the following signs/symptoms at the administration site during the solicited period?
    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
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    CL Item
    Day 4 (5)
    CL Item
    Day 5 (6)
    CL Item
    Day 6 (7)
    CL Item
    Day 7 (8)
    Redness
    Item
    Redness
    boolean
    If Yes, record the size
    Item
    If Yes, record the size
    integer
    Ongoing after day 7?
    Item
    Ongoing after day 7?
    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
    If Yes, record the visit type
    text
    If Yes, record the visit type
    Code List
    If Yes, record the visit type
    CL Item
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    CL Item
    Emergency room (2)
    CL Item
    Medical personnel (3)
    Item Group
    Local Symptoms - Swelling
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    CL Item
    Day 4 (5)
    CL Item
    Day 5 (6)
    CL Item
    Day 6 (7)
    CL Item
    Day 7 (8)
    Swelling
    Item
    Swelling
    boolean
    If Yes, record the size
    Item
    If Yes, record the size
    integer
    Ongoing after day 7?
    Item
    Ongoing after day 7?
    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
    If Yes, record the visit type
    text
    If Yes, record the visit type
    Code List
    If Yes, record the visit type
    CL Item
    Hospitalisation (1)
    CL Item
    Emergency room (2)
    CL Item
    Medical personnel (3)
    Item Group
    Local Symptoms - Pain
    Item
    Day
    integer
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    CL Item
    Day 4 (5)
    CL Item
    Day 5 (6)
    CL Item
    Day 6 (7)
    CL Item
    Day 7 (8)
    Pain
    Item
    Pain
    boolean
    Item
    If Yes, record the intensity
    text
    If Yes, record the intensity
    Code List
    If Yes, record the intensity
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Ongoing after day 7?
    Item
    Ongoing after day 7?
    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
    If Yes, record the visit type
    text
    If Yes, record the visit type
    Code List
    If Yes, record the visit type
    CL Item
    Hospitalisation (1)
    CL Item
    Emergency room (2)
    CL Item
    Medical personnel (3)
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