0 Avaliações
ID

14998

Descrição

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553. The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™. The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine. NCT00370396 Part: Diary Card: General Symptoms

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Versões (3)
  1. 10/05/2016 10/05/2016 -
  2. 11/05/2016 11/05/2016 -
  3. 20/09/2021 20/09/2021 -
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11 de maio de 2016

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Creative Commons BY-NC 3.0
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    Diary Card: General Symptoms Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals 10-valent Pneumococcal Conjugate Vaccine NCT00370396

    Inglês

    Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

    1 Formulários  
    Identification
    Descrição

    Identification

    Alias
    UMLS CUI-1
    C1300638 (Identification number)
    SNOMED
    396278008
    Center number
    Descrição

    Center number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0805701 (Code)
    Subject ID
    Descrição

    Subject ID

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Treatment Number
    Descrição

    Treatment Number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1522541 (Protocol Treatment Arm)
    Date of birth
    Descrição

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451 (Patient date of birth)
    SNOMED
    184099003
    LOINC
    LP57552-9
    Gender
    Descrição

    Gender

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0079399 (Gender)
    SNOMED
    263495000
    LOINC
    LP61312-2
    Date of vaccination
    Descrição

    Vaccination Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1115436 (Date and time of vaccination)
    LOINC
    MTHU014523
    General Symptoms
    Descrição

    General Symptoms

    Alias
    UMLS CUI-1
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    Symptom
    Descrição

    Please fill in below and assess the occurrence of any of the followinq siqns or symptoms accordinq to the criteria listed hereafter: Temperature: Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day. Intensity: Irritability / fussiness: 0: Behavior as usual Drowsiness: Loss of appetite: 0: Behavior as usual 0: Appetite as usual 1: Crying more than usual I no effect on normal activity 2: Crying more than usual I interferes with normal activity 3: Crying that cannot be comforted I prevents normal 1: Drowsiness easily tolerated 2: Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity 1: Eating less than usual I no effect on normal activity activity 2: Eating less than usual I interferes with normal activity 3: Not eating at all Other general svmptoms: 1:Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2:Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3:Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kinderqarten/a day-care center and would cause the parents/guardians to seek medical advice).

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    Temperature / Intensity
    Descrição

    Temperature / Intensity Day 0

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0518690 (Symptom intensity)
    UMLS CUI [2]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    Temperature Measurement site
    Descrição

    Temperature Measurement site

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1515974 (Anatomic Site)
    Temperature / Intensity Day 1
    Descrição

    Temperature / Intensity Day 1

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0518690 (Symptom intensity)
    UMLS CUI [2]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    Temperature / Intensity Day 2
    Descrição

    Temperature / Intensity Day 2

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0518690 (Symptom intensity)
    UMLS CUI [2]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    Temperature / Intensity Day 3
    Descrição

    Temperature / Intensity Day 3

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0518690 (Symptom intensity)
    UMLS CUI [2]
    C0039476 (Temperature)
    SNOMED
    703421000
    LOINC
    MTHU009008
    Ongoing after Day 3
    Descrição

    Ongoing after Day 3

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    Date of last Symptoms
    Descrição

    Date of last Symptoms

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Medically attended visit
    Descrição

    Medically attended visit

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Other General Symptoms
    Descrição

    Other General Symptoms

    Alias
    UMLS CUI-1
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    Description
    Descrição

    Description

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0678257 (Description)
    LOINC
    LP6800-9
    Intensity
    Descrição

    Intensity

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0522510 (With intensity)
    SNOMED
    103370009
    Start date:
    Descrição

    Start Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    End date
    Descrição

    End date

    Tipo de dados

    date

    Unidades de medida
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    dd/mm/yy
    Medically attended visit
    Descrição

    Medically attended visit

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Medication
    Descrição

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Trade/Generic name
    Descrição

    Name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0027365 (Name)
    SNOMED
    703503000
    LOINC
    LP72974-6
    Reason
    Descrição

    Reason

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    total daily dose
    Descrição

    total daily dose

    Tipo de dados

    text

    Unidades de medida
    • mg
    Alias
    UMLS CUI [1]
    C2348070 (Daily Dose)
    mg
    Start date
    Descrição

    Start date

    Tipo de dados

    date

    Unidades de medida
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    dd/mm/yy
    End date
    Descrição

    End date

    Tipo de dados

    date

    Unidades de medida
    • dd/mm/yy
    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    dd/mm/yy
    Continuing
    Descrição

    Continuing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0750536 (undefined)
    Administration
    Descrição

    Administration

    Please Do Not Forget To Bring Back The Diary Card On
    Descrição

    Return Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0489552 (undefined)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    In Case Of Hospitalisation, Please Inform
    Descrição

    Telephone number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1515258 (Telephone Number)
    SNOMED
    734005006
    LOINC
    LP6871-0
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    Similar models

    Diary Card: General Symptoms "Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine" NCT00370396

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Identification
    C1300638 (UMLS CUI-1)
    Center number
    Item
    Center number
    text
    C1301943 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Subject ID
    Item
    Subject ID
    text
    C2348585 (UMLS CUI [1])
    Treatment Number
    Item
    Treatment Number
    text
    C1522541 (UMLS CUI [1])
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (m)
    CL Item
    Female (f)
    Vaccination Date
    Item
    Date of vaccination
    date
    C1115436 (UMLS CUI [1])
    Item Group
    General Symptoms
    C1457887 (UMLS CUI-1)
    Item
    Symptom
    integer
    C1457887 (UMLS CUI [1])
    Symptom
    Code List
    Symptom
    CL Item
    Temperature (1)
    CL Item
    Irritability/Fussiness (2)
    CL Item
    Drowsiness (3)
    CL Item
    Loss of Appetite (4)
    Temperature / Intensity Day 0
    Item
    Temperature / Intensity
    text
    C0518690 (UMLS CUI [1])
    C0039476 (UMLS CUI [2])
    Item
    Temperature Measurement site
    integer
    C1515974 (UMLS CUI [1])
    Temperature Measurement site
    Code List
    Temperature Measurement site
    CL Item
    Axillary (1)
    CL Item
    Oral (2)
    CL Item
    Tymp (oral setting) (3)
    CL Item
    Tymp (rectal setting) (4)
    CL Item
    Rectal (preferably) (5)
    Item
    Temperature / Intensity Day 1
    text
    C0518690 (UMLS CUI [1])
    C0039476 (UMLS CUI [2])
    Temperature / Intensity Day 1
    Code List
    Temperature / Intensity Day 1
    Temperature / Intensity Day 2
    Item
    Temperature / Intensity Day 2
    text
    C0518690 (UMLS CUI [1])
    C0039476 (UMLS CUI [2])
    Temperature / Intensity Day 3
    Item
    Temperature / Intensity Day 3
    text
    C0518690 (UMLS CUI [1])
    C0039476 (UMLS CUI [2])
    Ongoing after Day 3
    Item
    Ongoing after Day 3
    boolean
    C0449238 (UMLS CUI [1])
    Date of last Symptoms
    Item
    Date of last Symptoms
    date
    C1457887 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1])
    Item Group
    Other General Symptoms
    C1457887 (UMLS CUI-1)
    Description
    Item
    Description
    text
    C0678257 (UMLS CUI [1])
    Intensity
    Item
    Intensity
    integer
    C0522510 (UMLS CUI [1])
    Start Date
    Item
    Start date:
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Medically attended visit
    Item
    Medically attended visit
    boolean
    C0545082 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Name
    Item
    Trade/Generic name
    text
    C0027365 (UMLS CUI [1])
    Reason
    Item
    Reason
    text
    C0392360 (UMLS CUI [1])
    total daily dose
    Item
    total daily dose
    text
    C2348070 (UMLS CUI [1])
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1])
    Continuing
    Item
    Continuing
    boolean
    C0750536 (UMLS CUI [1])
    Item Group
    Administration
    Return Date
    Item
    Please Do Not Forget To Bring Back The Diary Card On
    date
    C0489552 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Telephone number
    Item
    In Case Of Hospitalisation, Please Inform
    integer
    C1515258 (UMLS CUI [1])
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