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ID

37969

Descrição

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. In addition to the use of samples for the tests described in the protocol, the sponsor might use samples for additional research; therefore, this form records what is also covered by the subject Informed Consent form of each center.

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Versões (1)
  1. 03/09/2019 03/09/2019 -
Titular dos direitos

GlaxoSmithKline

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3 de setembro de 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

    Inglês

    Use of Human Samples

    1 Formulários  
    1. StudyEvent: ODM
      1. Use of Human Samples
    Administrative data
    Descrição

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Center Number
    Descrição

    Center Number

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1301943 (Institution name)
    SNOMED
    398321007
    UMLS CUI [1,2]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    Use of human samples by GSK
    Descrição

    Use of human samples by GSK

    Alias
    UMLS CUI-1
    C2347026 (Biospecimen)
    UMLS CUI-2
    C0086418 (Homo sapiens)
    SNOMED
    337915000
    UMLS CUI-3
    C0457083 (Usage)
    SNOMED
    277889008
    UMLS CUI-4
    C2347796 (Clinical Study Sponsor)
    Quality Assurance of tests described in the protocol
    Descrição

    This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably.

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0178932 (quality assurance)
    UMLS CUI [1,2]
    C0039593 (Testing)
    UMLS CUI [1,3]
    C1507394 (Clinical trial protocol document)
    LOINC
    LP33258-2
    Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetics testing.
    Descrição

    Vaccine research and research in diseases under study, excludig genetic testing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C0035168 (research)
    UMLS CUI [1,3]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [1,4]
    C0243064 (Genetic Research)
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C0035168 (research)
    UMLS CUI [2,3]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [2,4]
    C0243064 (Genetic Research)
    Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetic testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.
    Descrição

    {adapt to local naming}

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C0035168 (research)
    UMLS CUI [1,3]
    C2346499 (Institutional Review Board Approval)
    UMLS CUI [1,4]
    C0086911 (Ethics Committees, Research)
    UMLS CUI [1,5]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [1,6]
    C0243064 (Genetic Research)
    UMLS CUI [2,1]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    UMLS CUI [2,2]
    C0035168 (research)
    UMLS CUI [2,3]
    C2346499 (Institutional Review Board Approval)
    UMLS CUI [2,4]
    C0086911 (Ethics Committees, Research)
    UMLS CUI [2,5]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [2,6]
    C0243064 (Genetic Research)
    Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic testing and does not affect subject participation in the study.
    Descrição

    Anonymous research unrelated to this study, excluding genetic testing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0035168 (research)
    UMLS CUI [1,2]
    C2346787 (Anonymous)
    UMLS CUI [1,3]
    C0445356 (Unrelated (finding))
    SNOMED
    262241003
    LOINC
    LA31345-4
    UMLS CUI [1,4]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    UMLS CUI [1,5]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [1,6]
    C0243064 (Genetic Research)
    HIV Testing
    Descrição

    HIV Testing

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1321876 (Human immunodeficiency virus test)
    SNOMED
    165813002
    Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
    Descrição

    Storage period in informed consent form

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C1698986 (Storage)
    SNOMED
    440276004
    UMLS CUI [1,2]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,3]
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    UMLS CUI [1,4]
    C0021430 (Informed Consent)
    If other GSK storage period, please specify
    Descrição

    Specify other storage period

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1521902 (To specify)
    UMLS CUI [1,2]
    C0205394 (Other)
    SNOMED
    74964007
    LOINC
    LP21049-9
    UMLS CUI [1,3]
    C1698986 (Storage)
    SNOMED
    440276004
    UMLS CUI [1,4]
    C0449238 (Duration (temporal concept))
    SNOMED
    762636008
    LOINC
    LP14744-4
    UMLS CUI [1,5]
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    ICF Effective date
    Descrição

    Complete and submit a new form for each change during the study

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0009797 (Consent Forms)
    Investigator's signature
    Descrição

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Investigator's signature
    Descrição

    Investigator's signature

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Printed Investigator's name
    Descrição

    Printed Investigator's name

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Date of investigator's signature
    Descrição

    Date of investigator's signature

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Similar models

    Use of Human Samples

    1 Formulários
    1. StudyEvent: ODM
      1. Use of Human Samples
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Center Number
    Item
    Center Number
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Item Group
    Use of human samples by GSK
    C2347026 (UMLS CUI-1)
    C0086418 (UMLS CUI-2)
    C0457083 (UMLS CUI-3)
    C2347796 (UMLS CUI-4)
    Quality Assurance of tests described in the protocol
    Item
    Quality Assurance of tests described in the protocol
    boolean
    C0178932 (UMLS CUI [1,1])
    C0039593 (UMLS CUI [1,2])
    C1507394 (UMLS CUI [1,3])
    Vaccine research and research in diseases under study, excludig genetic testing
    Item
    Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetics testing.
    boolean
    C0042210 (UMLS CUI [1,1])
    C0035168 (UMLS CUI [1,2])
    C1705847 (UMLS CUI [1,3])
    C0243064 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0035168 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [2,3])
    C0243064 (UMLS CUI [2,4])
    Vaccine research and research in diseases under study, excluding genetic testing, with ethics review
    Item
    Further investigation by GSK Biologicals into the ability of the vaccines to protect people if any findings from related studies require it and further research in the diseases under study. These investigations exclude genetic testing. Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.
    boolean
    C0042210 (UMLS CUI [1,1])
    C0035168 (UMLS CUI [1,2])
    C2346499 (UMLS CUI [1,3])
    C0086911 (UMLS CUI [1,4])
    C1705847 (UMLS CUI [1,5])
    C0243064 (UMLS CUI [1,6])
    C0012634 (UMLS CUI [2,1])
    C0035168 (UMLS CUI [2,2])
    C2346499 (UMLS CUI [2,3])
    C0086911 (UMLS CUI [2,4])
    C1705847 (UMLS CUI [2,5])
    C0243064 (UMLS CUI [2,6])
    Anonymous research unrelated to this study, excluding genetic testing
    Item
    Further research by GSK Biologicals that is NOT RELATED to the vaccines or the diseases under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic testing and does not affect subject participation in the study.
    boolean
    C0035168 (UMLS CUI [1,1])
    C2346787 (UMLS CUI [1,2])
    C0445356 (UMLS CUI [1,3])
    C0008976 (UMLS CUI [1,4])
    C1705847 (UMLS CUI [1,5])
    C0243064 (UMLS CUI [1,6])
    HIV Testing
    Item
    HIV Testing
    boolean
    C1321876 (UMLS CUI [1])
    Item
    Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
    integer
    C1698986 (UMLS CUI [1,1])
    C0449238 (UMLS CUI [1,2])
    C0370003 (UMLS CUI [1,3])
    C0021430 (UMLS CUI [1,4])
    GSK storage period, informed consent form
    Code List
    Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
    CL Item
    At least 15 years storage period by GSK Biologicals (1)
    CL Item
    Other (2)
    Specify other storage period
    Item
    If other GSK storage period, please specify
    text
    C1521902 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1698986 (UMLS CUI [1,3])
    C0449238 (UMLS CUI [1,4])
    C0370003 (UMLS CUI [1,5])
    ICF Effective date
    Item
    ICF Effective date
    date
    C0011008 (UMLS CUI [1,1])
    C0009797 (UMLS CUI [1,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    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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