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ID

37887

Description

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form is to be used in case of a meningitis, and e.g. includes information on symptoms and lumbar puncture. This form shall be filled in in addition to a regular SAE form.

Keywords

Versions (1)
  1. 8/28/19 8/28/19 -
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GlaxoSmithKline

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August 28, 2019

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Creative Commons BY-NC 3.0
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    10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

    English

    Meningitis Report

    1 forms  
    1. StudyEvent: ODM
      1. Meningitis Report
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Country
    Description

    Country

    Data type

    text

    Alias
    UMLS CUI [1]
    C0454664
    Center Number
    Description

    Center Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Treatment Number
    Description

    Treatment Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1522541
    UMLS CUI [1,2]
    C0600091
    Attached to SAE Report No
    Description

    Attached to SAE Report No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0684224
    UMLS CUI [1,3]
    C0237753
    Meningitis Report No
    Description

    Meningitis Report No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0684224
    UMLS CUI [1,2]
    C0237753
    UMLS CUI [1,3]
    C0025289
    Sponsor receipt date
    Description

    (for GSK use)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2985846
    UMLS CUI [1,2]
    C2347796
    Type of report
    Description

    Type of report

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0585733
    Date of first symptoms
    Description

    Date of first symptoms

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0011008
    Section 1: Clinical Symptoms
    Description

    Section 1: Clinical Symptoms

    Alias
    UMLS CUI-1
    C1457887
    Signs and Symptoms
    Description

    Please complete itemgroup repeatedly for each symptom/sign

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0037088
    Was the symptom observed/present?
    Description

    Signs and Symptoms, Assesment

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1441672
    UMLS CUI [1,2]
    C0037088
    Section 2: Blood Test
    Description

    Section 2: Blood Test

    Alias
    UMLS CUI-1
    C0005834
    Date of blood test
    Description

    Date of blood test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Was antibiotic treatment initiated prior to the blood culture?
    Description

    Antibiotic treatment initiated prior to blood culture

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0338237
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0200949
    Species in blood culture
    Description

    Species in blood culture

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0200949
    UMLS CUI [1,2]
    C1705920
    Serology results
    Description

    Serology results

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0036743
    UMLS CUI [1,2]
    C1274040
    Other blood tests
    Description

    Other blood tests

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0022885
    Section 3: Lumbar Puncture
    Description

    Section 3: Lumbar Puncture

    Alias
    UMLS CUI-1
    C0553794
    Date of lumbar puncture
    Description

    Date of lumbar puncture

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0553794
    UMLS CUI [1,2]
    C0011008
    Was antibiotic treatment initiated prior to the lumbar puncture?
    Description

    Antibiotic treatment prior lumbar puncture

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0338237
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0553794
    CSF appearance: Clear
    Description

    Select all appearance items that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C2963144
    CSF appearance: Turbid
    Description

    Select all appearance items that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0311420
    CSF appearance: purulent
    Description

    Select all appearance items that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0439665
    CSF appearance: Hematic
    Description

    Select all appearance items that apply

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0333275
    CSF: Total WBC count
    Description

    CSF: Total WBC count

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C0023508
    UMLS CUI [1,2]
    C0007806
    x 10^6/L
    CSF: Polymorphonuclears (PMNs) percentage
    Description

    give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)

    Data type

    float

    Measurement units
    • % of total WBC
    Alias
    UMLS CUI [1,1]
    C1168338
    UMLS CUI [1,2]
    C1549488
    UMLS CUI [1,3]
    C0007806
    % of total WBC
    CSF: Polymorphonuclears (PMNs) absolute
    Description

    give one of the two Polymorphonuclears (PMNs) units (percentage/absolute)

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C1168338
    UMLS CUI [1,2]
    C0007806
    x 10^6/L
    CSF: Mononuclear lymphocytes percentage
    Description

    record one of the two Mononuclear lymphocyte units (percentage/absolute)

    Data type

    float

    Measurement units
    • % of total WBC
    Alias
    UMLS CUI [1,1]
    C1513475
    UMLS CUI [1,2]
    C0200635
    UMLS CUI [1,3]
    C1549488
    UMLS CUI [1,4]
    C0007806
    % of total WBC
    CSF: Mononuclear lymphocytes absolute
    Description

    record one of the two Mononuclear lymphocyte units (percentage/absolute)

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C1513475
    UMLS CUI [1,2]
    C0200635
    UMLS CUI [1,3]
    C0007806
    x 10^6/L
    CSF: Total RBC count
    Description

    CSF: Total RBC count

    Data type

    float

    Measurement units
    • x 10^6/L
    Alias
    UMLS CUI [1,1]
    C0014772
    UMLS CUI [1,2]
    C0007806
    x 10^6/L
    CSF: Protein content
    Description

    CSF: Protein content

    Data type

    float

    Measurement units
    • g/L
    Alias
    UMLS CUI [1,1]
    C0555903
    UMLS CUI [1,2]
    C0007806
    g/L
    CSF Glucose content
    Description

    Record in mmol/L, g/L or percentage

    Data type

    float

    Measurement units
    • mmol/L
    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0007806
    mmol/L
    CSF Glucose content
    Description

    Record in mmol/L, g/L or percentage

    Data type

    float

    Measurement units
    • g/L
    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0007806
    g/L
    CSF Glucose content
    Description

    Record in mmol/L, g/L or percentage

    Data type

    float

    Measurement units
    • % plasma glucose concentration
    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0007806
    % plasma glucose concentration
    Plasma glucose concentration
    Description

    Record in g/L or mmol/L

    Data type

    float

    Measurement units
    • g/L
    Alias
    UMLS CUI [1]
    C0202042
    g/L
    Plasma glucose concentration
    Description

    Record in g/L or mmol/L

    Data type

    float

    Measurement units
    • mmol/L
    Alias
    UMLS CUI [1]
    C0202042
    mmol/L
    Gram stain result
    Description

    Gram stain result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0061856
    UMLS CUI [1,2]
    C1274040
    CSF Culture: Species 1
    Description

    CSF Culture: Species 1

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C1705920
    CSF Culture: Serotype/group 1
    Description

    CSF Culture: Serotype/group 1

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C0449943
    CSF Culture: Species 2
    Description

    CSF Culture: Species 2

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C1705920
    CSF Culture: Serotype/group 2
    Description

    CSF Culture: Serotype/group 2

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0007806
    UMLS CUI [1,2]
    C0430400
    UMLS CUI [1,3]
    C0449943
    CSF Latex agglutination test (LAT)
    Description

    CSF Latex agglutination test (LAT)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2026623
    Other CSF antigen detection test
    Description

    (e.g. Binax Now)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0729856
    UMLS CUI [1,3]
    C0007806
    Other CSF antigen detection test result
    Description

    Other CSF antigen detection test result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0729856
    UMLS CUI [1,3]
    C0007806
    UMLS CUI [1,4]
    C1274040
    CSF PCR Result
    Description

    CSF PCR Result

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2026647
    UMLS CUI [1,2]
    C1274040
    Investigator's signature
    Description

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Type of report
    Description

    Type of report

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0585733
    Investigator's signature
    Description

    Please do not forget to complete a Serious Adverse Event Form

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Printed Investigator's name
    Description

    Printed Investigator's name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Date of investigator's signature
    Description

    Date of investigator's signature

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Meningitis Report

    1 forms
    1. StudyEvent: ODM
      1. Meningitis Report
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Country
    Item
    Country
    text
    C0454664 (UMLS CUI [1])
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Treatment Number
    Item
    Treatment Number
    integer
    C1522541 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Attached to SAE Report No
    Item
    Attached to SAE Report No
    integer
    C1519255 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Meningitis Report No
    Item
    Meningitis Report No
    integer
    C0684224 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C0025289 (UMLS CUI [1,3])
    Sponsor receipt date
    Item
    Sponsor receipt date
    date
    C2985846 (UMLS CUI [1,1])
    C2347796 (UMLS CUI [1,2])
    Item
    Type of report
    integer
    C0585733 (UMLS CUI [1])
    Type of report
    Code List
    Type of report
    CL Item
    Initial report (1)
    CL Item
    First follow-up (2)
    CL Item
    Second follow-up (3)
    CL Item
    Third follow-up (4)
    Date of first symptoms
    Item
    Date of first symptoms
    date
    C1457887 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Section 1: Clinical Symptoms
    C1457887 (UMLS CUI-1)
    Item
    Signs and Symptoms
    integer
    C0037088 (UMLS CUI [1])
    Signs and Symptoms
    Code List
    Signs and Symptoms
    CL Item
    Fever (1)
    CL Item
    Headache (2)
    CL Item
    Stiff neck or positive Kernig's or Brudzinski's signs  (3)
    CL Item
    Nausea (4)
    CL Item
    Vomiting (5)
    CL Item
    Photophobia (discomfort from bright light)  (6)
    CL Item
    Confusion (7)
    CL Item
    Sleepiness  (8)
    CL Item
    Seizure  (9)
    CL Item
    Tensing or bulging of fontanel (10)
    CL Item
    Rash  (11)
    CL Item
    Petechia or purpuric rash  (12)
    CL Item
    Refusing to feed  (13)
    CL Item
    Irritable when picked up, with high pitched or moaning cry (14)
    CL Item
    A stiff body with jerky movements (15)
    CL Item
    Floppy body and lifeless  (16)
    Item
    Was the symptom observed/present?
    integer
    C1441672 (UMLS CUI [1,1])
    C0037088 (UMLS CUI [1,2])
    Signs and Symptoms
    Code List
    Was the symptom observed/present?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    Unknown (3)
    Item Group
    Section 2: Blood Test
    C0005834 (UMLS CUI-1)
    Date of blood test
    Item
    Date of blood test
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was antibiotic treatment initiated prior to the blood culture?
    integer
    C0338237 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0200949 (UMLS CUI [1,3])
    Antibiotic treatment initiated prior to blood culture
    Code List
    Was antibiotic treatment initiated prior to the blood culture?
    CL Item
    No (1)
    CL Item
    Yes  (2)
    CL Item
    Unknown (3)
    Species in blood culture
    Item
    Species in blood culture
    text
    C0200949 (UMLS CUI [1,1])
    C1705920 (UMLS CUI [1,2])
    Serology results
    Item
    Serology results
    text
    C0036743 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Other blood tests
    Item
    Other blood tests
    text
    C0205394 (UMLS CUI [1,1])
    C0022885 (UMLS CUI [1,2])
    Item Group
    Section 3: Lumbar Puncture
    C0553794 (UMLS CUI-1)
    Date of lumbar puncture
    Item
    Date of lumbar puncture
    date
    C0553794 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Was antibiotic treatment initiated prior to the lumbar puncture?
    integer
    C0338237 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0553794 (UMLS CUI [1,3])
    Antibiotic treatment prior lumbar puncture
    Code List
    Was antibiotic treatment initiated prior to the lumbar puncture?
    CL Item
    No (1)
    CL Item
    Yes (2)
    CL Item
    Unknown (3)
    CSF appearance: Clear
    Item
    CSF appearance: Clear
    boolean
    C0007806 (UMLS CUI [1,1])
    C2963144 (UMLS CUI [1,2])
    CSF appearance: Turbid
    Item
    CSF appearance: Turbid
    boolean
    C0007806 (UMLS CUI [1,1])
    C0311420 (UMLS CUI [1,2])
    CSF appearance: purulent
    Item
    CSF appearance: purulent
    boolean
    C0007806 (UMLS CUI [1,1])
    C0439665 (UMLS CUI [1,2])
    CSF appearance: Hematic
    Item
    CSF appearance: Hematic
    boolean
    C0007806 (UMLS CUI [1,1])
    C0333275 (UMLS CUI [1,2])
    CSF: Total WBC count
    Item
    CSF: Total WBC count
    float
    C0023508 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF: Polymorphonuclears (PMNs) percentage
    Item
    CSF: Polymorphonuclears (PMNs) percentage
    float
    C1168338 (UMLS CUI [1,1])
    C1549488 (UMLS CUI [1,2])
    C0007806 (UMLS CUI [1,3])
    CSF: Polymorphonuclears (PMNs) absolute
    Item
    CSF: Polymorphonuclears (PMNs) absolute
    float
    C1168338 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF: Mononuclear lymphocytes percentage
    Item
    CSF: Mononuclear lymphocytes percentage
    float
    C1513475 (UMLS CUI [1,1])
    C0200635 (UMLS CUI [1,2])
    C1549488 (UMLS CUI [1,3])
    C0007806 (UMLS CUI [1,4])
    CSF: Mononuclear lymphocytes absolute
    Item
    CSF: Mononuclear lymphocytes absolute
    float
    C1513475 (UMLS CUI [1,1])
    C0200635 (UMLS CUI [1,2])
    C0007806 (UMLS CUI [1,3])
    CSF: Total RBC count
    Item
    CSF: Total RBC count
    float
    C0014772 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF: Protein content
    Item
    CSF: Protein content
    float
    C0555903 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF Glucose content
    Item
    CSF Glucose content
    float
    C0337438 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF Glucose content
    Item
    CSF Glucose content
    float
    C0337438 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    CSF Glucose content
    Item
    CSF Glucose content
    float
    C0337438 (UMLS CUI [1,1])
    C0007806 (UMLS CUI [1,2])
    Plasma glucose concentration
    Item
    Plasma glucose concentration
    float
    C0202042 (UMLS CUI [1])
    Plasma glucose concentration
    Item
    Plasma glucose concentration
    float
    C0202042 (UMLS CUI [1])
    Gram stain result
    Item
    Gram stain result
    text
    C0061856 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    CSF Culture: Species 1
    Item
    CSF Culture: Species 1
    text
    C0007806 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C1705920 (UMLS CUI [1,3])
    CSF Culture: Serotype/group 1
    Item
    CSF Culture: Serotype/group 1
    text
    C0007806 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C0449943 (UMLS CUI [1,3])
    CSF Culture: Species 2
    Item
    CSF Culture: Species 2
    text
    C0007806 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C1705920 (UMLS CUI [1,3])
    CSF Culture: Serotype/group 2
    Item
    CSF Culture: Serotype/group 2
    text
    C0007806 (UMLS CUI [1,1])
    C0430400 (UMLS CUI [1,2])
    C0449943 (UMLS CUI [1,3])
    CSF Latex agglutination test (LAT)
    Item
    CSF Latex agglutination test (LAT)
    text
    C2026623 (UMLS CUI [1])
    Other CSF antigen detection test
    Item
    Other CSF antigen detection test
    text
    C0205394 (UMLS CUI [1,1])
    C0729856 (UMLS CUI [1,2])
    C0007806 (UMLS CUI [1,3])
    Other CSF antigen detection test result
    Item
    Other CSF antigen detection test result
    text
    C0205394 (UMLS CUI [1,1])
    C0729856 (UMLS CUI [1,2])
    C0007806 (UMLS CUI [1,3])
    C1274040 (UMLS CUI [1,4])
    CSF PCR Result
    Item
    CSF PCR Result
    text
    C2026647 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Item
    Type of report
    integer
    C0585733 (UMLS CUI [1])
    Type of report
    Code List
    Type of report
    CL Item
    Initial report (1)
    CL Item
    First follow-up (2)
    CL Item
    Second follow-up (3)
    CL Item
    Third follow-up (4)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Printed Investigator's name
    Item
    Printed Investigator's name
    text
    C2826892 (UMLS CUI [1])
    Date of investigator's signature
    Item
    Date of investigator's signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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