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ID

33494

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. 12/11/18 12/11/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 11, 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: General Symptoms (DTPw-HBV Kft+HiberixTM)

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Protocol Number
    Description

    Protocol Number

    Data type

    integer

    General Symptoms
    Description

    General Symptoms

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

    assess the occurrence of general signs or symptoms

    Data type

    text

    Temperature
    Description

    Temperature

    Day
    Description

    Day

    Data type

    text

    Route
    Description

    Route

    Data type

    integer

    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    °C
    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

    Was the visit medically attended?
    Description

    Medically attended Visit?

    Data type

    boolean

    Irritability/Fussiness
    Description

    Irritability/Fussiness

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    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

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Was the crying continuous?
    Description

    In case of crying that connot be comforted and prevents normal activity; i.e. not episodic, not interrupted within the time period of 3 hours by e.g. naps?

    Data type

    boolean

    Was the crying unaltered >=3 hours?
    Description

    unaltered crying >= 3 hrs

    Data type

    boolean

    Drowsiness
    Description

    Drowsiness

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    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

    medically attended visit?
    Description

    medically attended visit?

    Data type

    boolean

    Loss of Appetite
    Description

    Loss of Appetite

    Day
    Description

    Day

    Data type

    integer

    Intensity
    Description

    Intensity

    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

    medically attended visit?
    Description

    medically attended visit?

    Data type

    boolean

    Other General Symptoms
    Description

    Other General Symptoms

    Description
    Description

    please give details below

    Data type

    integer

    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

    Was the visit medically attended?
    Description

    medically attended visit?

    Data type

    boolean

    Medications
    Description

    Medications

    Trade name/Generic name
    Description

    Trade name/Generic name

    Data type

    text

    Reason
    Description

    Reason

    Data type

    text

    Total daily dose
    Description

    Total daily dose

    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

    Reminder
    Description

    Reminder

    Please do not forget to bring back the diary card on
    Description

    Record the date below

    Data type

    date

    Back to the top of the page

    Similar models

    Diary card: General Symptoms (DTPw-HBV Kft+HiberixTM)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Protocol Number
    Item
    Protocol Number
    integer
    Item Group
    General Symptoms
    assess the occurrence of general signs or symptoms
    Item
    Please fill in below and assess the occurrence of any of the following signs or symptoms according to the criteria listed below.
    text
    Item Group
    Temperature
    Item
    Day
    text
    Day
    Code List
    Day
    CL Item
    Day 0 (1)
    CL Item
    Day 1 (2)
    CL Item
    Day 2 (3)
    CL Item
    Day 3 (4)
    Item
    Route
    integer
    Route
    Code List
    Route
    CL Item
    Axillary (1)
    CL Item
    Oral (2)
    CL Item
    Tympanic oral (3)
    CL Item
    Tympanic rectal (4)
    CL Item
    Rectal (5)
    Temperature
    Item
    Temperature
    float
    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
    Medically attended Visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Irritability/Fussiness
    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
    text
    Intensity
    Code List
    Intensity
    CL Item
    Behaviour as usual (1)
    CL Item
    Crying more than usual/ no effect on normal activity (2)
    CL Item
    Crying more than usual/ interferes with normal activity (3)
    CL Item
    Crying that cannot be comforted/ prevents normal activity (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
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Continuous crying?
    Item
    Was the crying continuous?
    boolean
    unaltered crying >= 3 hrs
    Item
    Was the crying unaltered >=3 hours?
    boolean
    Item Group
    Drowsiness
    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
    text
    Intensity
    Code List
    Intensity
    CL Item
    Behavior as usual (1)
    CL Item
    Drowsiness easily tolerated (2)
    CL Item
    Drowsiness that interferes with normal activity (3)
    CL Item
    Drowsiness that prevents normal activity (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
    medically attended visit?
    Item
    medically attended visit?
    boolean
    Item Group
    Loss of Appetite
    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
    text
    Intensity
    Code List
    Intensity
    CL Item
    Appetite as usual (1)
    CL Item
    Eating less than usual / no effect on normal activity (2)
    CL Item
    Eating less than usual / interferes with normal activity (3)
    CL Item
    Not eating at all (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
    medically attended visit?
    Item
    medically attended visit?
    boolean
    Item Group
    Other General Symptoms
    Description
    Item
    Description
    integer
    Item
    Intensity
    text
    Intensity
    Code List
    Intensity
    CL Item
    Mild (an AE which is easily tolerated by the subject, causing minimal discomfort and non interfering with everyday activities) (1)
    CL Item
    Moderate (an AE which is sufficiently discomforting to interfere with normal everyday activities) (2)
    CL Item
    Severe (an AE which prevents normal, everyday activities: attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice) (3)
    Start date
    Item
    Start date
    date
    End date
    Item
    End date
    date
    Ongoing?
    Item
    Ongoing?
    boolean
    medically attended visit?
    Item
    Was the visit medically attended?
    boolean
    Item Group
    Medications
    Trade name/Generic name
    Item
    Trade name/Generic name
    text
    Reason
    Item
    Reason
    text
    Total daily dose
    Item
    Total daily dose
    text
    Start date
    Item
    Start date
    date
    End date
    Item
    End date
    date
    Ongoing?
    Item
    Ongoing?
    boolean
    Item Group
    Reminder
    Please do not forget to bring back the diary card on
    Item
    Please do not forget to bring back the diary card on
    date
    Back to the top of the page 

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