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ID

35525

Description

Study ID: 111652 Clinical Study ID: 111652 Study Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00756067 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK2189241A Trade Name: Pneumo 23™ Study Indication: Infections, Streptococcal

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Versions (1)
  1. 3/7/19 3/7/19 -
Copyright Holder

GSK group of companies

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March 7, 2019

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Creative Commons BY-NC 3.0
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    Candidate Formulations of Pneumococcal Vaccines in Elderly Subjects - 111652

    English

    Visit 7 - Day 67 (7-8 day after visit 5)

    1 forms  
    Administrative data
    Description

    Administrative data

    Subject Number
    Description

    Subject Number

    Data type

    integer

    Visit Number
    Description

    Visit Number

    Data type

    text

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    CHECK FOR STUDY CONTINUATION
    Description

    CHECK FOR STUDY CONTINUATION

    Did the subject return for visit 1?
    Description

    Check for Study Continuation

    Data type

    boolean

    If No, please record ONE most appropriate reason and skip the following forms of this visit.
    Description

    If No, please record ONE most appropriate reason and skip the following forms of this visit.

    Data type

    text

    HEMATOLOGY / BIOCHEMISTRY
    Description

    HEMATOLOGY / BIOCHEMISTRY

    Has a blood sample been taken for haematology/ biochemistry testing?
    Description

    Hematology / Biochemistry Question

    Data type

    text

    Date
    Description

    Date

    Data type

    date

    Laboratory Name
    Description

    Laboratory Name

    Data type

    text

    Laboratory Code
    Description

    Laboratory Code

    Data type

    integer

    HEMATOLOGY
    Description

    HEMATOLOGY

    [HB] Hemoglobin
    Description

    Result

    Data type

    float

    Measurement units
    • g/dL
    g/dL
    [RBC] Red Blood Cells
    Description

    Result below

    Data type

    integer

    [PLA] Platelets
    Description

    Result below

    Data type

    text

    [WBC] White Blood Cells
    Description

    White Blood Cells

    Data type

    text

    [NEU] Neutrophils
    Description

    Result below

    Data type

    text

    Measurement units
    • abs
    abs
    [LYM] Lymphocytes
    Description

    Result below

    Data type

    integer

    Measurement units
    • /l
    /l
    [MON] Monocytes
    Description

    Result below

    Data type

    text

    [EOS] Eosinophils
    Description

    Result below

    Data type

    text

    [BAS] Basophils
    Description

    Result below

    Data type

    text

    [RET] Reticulocytes
    Description

    Result below

    Data type

    text

    BIOCHEMISTRY
    Description

    BIOCHEMISTRY

    [BUN] BUN
    Description

    BUN

    Data type

    float

    Measurement units
    • mg/dL
    mg/dL
    [CREA] Creatinine
    Description

    Result below

    Data type

    float

    Measurement units
    • mg/dL
    mg/dL
    [AST] AST/SGOT
    Description

    Result below

    Data type

    float

    Measurement units
    • U/L
    U/L
    [ALT] ALT/SGPT
    Description

    Result below

    Data type

    float

    Measurement units
    • U/L
    U/L
    [CHOL] Cholesterol
    Description

    Cholesterol

    Data type

    float

    [CPK] Creatine phosphokinase
    Description

    Creatine phosphokinase

    Data type

    float

    [HAP] Serum Haptoglobin
    Description

    Serum Haptoglobin

    Data type

    float

    Measurement units
    • mg/dL
    mg/dL
    [LDH] Lactate Dehydrogenase
    Description

    Please complete the following informationwith LDH isoenzymes if the grade 2 or greater LDH is observed (> 1.5 ULN)

    Data type

    text

    LDH
    Description

    LDH

    LD1
    Description

    Result

    Data type

    text

    LD2
    Description

    Result

    Data type

    text

    LD3
    Description

    Result

    Data type

    text

    LD4
    Description

    Result

    Data type

    text

    LD5
    Description

    Result

    Data type

    text

    Has a blood sample been taken for immunogenicity assays?
    Description

    Blood Sample for Immunogenicity Assays

    Data type

    boolean

    Date
    Description

    Date

    Data type

    date

    URINALYSIS
    Description

    URINALYSIS

    Has a urine sample been taken for dipstick?
    Description

    Urine Sample Question

    Data type

    boolean

    Date
    Description

    Date

    Data type

    date

    Urinalysis (Dipstick) Test
    Description

    Urinalysis (Dipstick) Test

    pH (via dipstick)
    Description

    Result

    Data type

    integer

    Proteins (via dipstick)
    Description

    Proteins (via dipstick)

    Data type

    text

    Glucose (via dipstick)
    Description

    Glucose (via dipstick)

    Data type

    text

    Ketones (via dipstick)
    Description

    Ketones (via dipstick)

    Data type

    text

    Blood and myoglobin (via dipstick)
    Description

    Blood and myoglobin (via dipstick)

    Data type

    text

    Bilirubin (via dipstick)
    Description

    Bilirubin (via dipstick)

    Data type

    text

    Urobilinogen (via dipstick)
    Description

    Urobilinogen (via dipstick)

    Data type

    text

    Nitrites (via dipstick)
    Description

    Nitrites (via dipstick)

    Data type

    text

    Leukocyte esterase (via dipstick)
    Description

    Leukocyte esterase (via dipstick)

    Data type

    text

    Has a urine sample been taken for development of diagnostic assay?
    Description

    Urina Sample for Diagnostic Sssay?

    Data type

    boolean

    Date
    Description

    Date

    Data type

    date

    Back to the top of the page

    Similar models

    Visit 7 - Day 67 (7-8 day after visit 5)

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Visit Number
    Item
    Visit Number
    text
    Date of Visit
    Item
    Date of Visit
    date
    Item Group
    CHECK FOR STUDY CONTINUATION
    Check for Study Continuation
    Item
    Did the subject return for visit 1?
    boolean
    If No, please record ONE most appropriate reason and skip the following forms of this visit.
    Item
    If No, please record ONE most appropriate reason and skip the following forms of this visit.
    text
    Item Group
    HEMATOLOGY / BIOCHEMISTRY
    Item
    Has a blood sample been taken for haematology/ biochemistry testing?
    text
    Hematology / Biochemistry Question
    Code List
    Has a blood sample been taken for haematology/ biochemistry testing?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    N/A (Only if Visit 1 occurred within 48 hours from blood sample taken at screening visit) (3)
    Date
    Item
    Date
    date
    Laboratory Name
    Item
    Laboratory Name
    text
    Laboratory Code
    Item
    Laboratory Code
    integer
    Item Group
    HEMATOLOGY
    [HB] Hemoglobin
    Item
    [HB] Hemoglobin
    float
    Red Blood Cells
    Item
    [RBC] Red Blood Cells
    integer
    Platelets
    Item
    [PLA] Platelets
    text
    White Blood Cells
    Item
    [WBC] White Blood Cells
    text
    Neutrophils
    Item
    [NEU] Neutrophils
    text
    Lymphocytes
    Item
    [LYM] Lymphocytes
    integer
    Monocytes
    Item
    [MON] Monocytes
    text
    Eosinophils
    Item
    [EOS] Eosinophils
    text
    Basophils
    Item
    [BAS] Basophils
    text
    Reticulocytes
    Item
    [RET] Reticulocytes
    text
    Item Group
    BIOCHEMISTRY
    BUN
    Item
    [BUN] BUN
    float
    Creatinine
    Item
    [CREA] Creatinine
    float
    AST/SGOT
    Item
    [AST] AST/SGOT
    float
    ALT/SGPT
    Item
    [ALT] ALT/SGPT
    float
    Cholesterol
    Item
    [CHOL] Cholesterol
    float
    Creatine phosphokinase
    Item
    [CPK] Creatine phosphokinase
    float
    Serum Haptoglobin
    Item
    [HAP] Serum Haptoglobin
    float
    Lactate Dehydrogenase
    Item
    [LDH] Lactate Dehydrogenase
    text
    Item Group
    LDH
    LD1
    Item
    LD1
    text
    LD2
    Item
    LD2
    text
    LD3
    Item
    LD3
    text
    LD4
    Item
    LD4
    text
    LD5
    Item
    LD5
    text
    Blood Sample for Immunogenicity Assays
    Item
    Has a blood sample been taken for immunogenicity assays?
    boolean
    Date
    Item
    Date
    date
    Item Group
    URINALYSIS
    Urine Sample Question
    Item
    Has a urine sample been taken for dipstick?
    boolean
    Date
    Item
    Date
    date
    Item Group
    Urinalysis (Dipstick) Test
    pH (via dipstick)
    Item
    pH (via dipstick)
    integer
    Item
    Proteins (via dipstick)
    text
    Proteins (via dipstick)
    Code List
    Proteins (via dipstick)
    CL Item
    negative  (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    Item
    Glucose (via dipstick)
    text
    Glucose (via dipstick)
    Code List
    Glucose (via dipstick)
    CL Item
    normal (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    CL Item
    4+ (5)
    Item
    Ketones (via dipstick)
    text
    Ketones (via dipstick)
    Code List
    Ketones (via dipstick)
    CL Item
    negative (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    Item
    Blood and myoglobin (via dipstick)
    text
    Blood and myoglobin (via dipstick)
    Code List
    Blood and myoglobin (via dipstick)
    CL Item
    negative (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    CL Item
    4+ (5)
    Item
    Bilirubin (via dipstick)
    text
    Bilirubin (via dipstick)
    Code List
    Bilirubin (via dipstick)
    CL Item
    negative (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    Item
    Urobilinogen (via dipstick)
    text
    Urobilinogen (via dipstick)
    Code List
    Urobilinogen (via dipstick)
    CL Item
    normal (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    CL Item
    4+ (5)
    Item
    Nitrites (via dipstick)
    text
    Nitrites (via dipstick)
    Code List
    Nitrites (via dipstick)
    CL Item
    negative (1)
    CL Item
    positive (2)
    Item
    Leukocyte esterase (via dipstick)
    text
    Leukocyte esterase (via dipstick)
    Code List
    Leukocyte esterase (via dipstick)
    CL Item
    negative (1)
    CL Item
    1+ (2)
    CL Item
    2+ (3)
    CL Item
    3+ (4)
    Urina Sample for Diagnostic Sssay?
    Item
    Has a urine sample been taken for development of diagnostic assay?
    boolean
    Date
    Item
    Date
    date
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