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ID

33521

Description

Study ID: 104297 Clinical Study ID: 104297 Study Title: An open study for a 2-year period to confirm the safety and immunogenicity of the candidate malaria vaccine RTS,S/AS02A in Mozambican children aged 1 to 4 years at the time of first vaccine dose. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00323622 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: SB257049 Study Indication: Malaria

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Versions (4)
  1. 11/12/18 11/12/18 -
  2. 06/06/19 06/06/19 -
  3. 12/06/19 12/06/19 -
  4. 27/09/21 27/09/21 -
Détendeur de droits

GSK group of companies

Téléchargé le

11 dicembre 2018

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Licence

Creative Commons BY-NC 3.0
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    Immunogenicity of malaria vaccine candidate in Mozambican children (1 to 4 y.o) - 104297 (Malaria039)

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    Visit 2: Laboratory Tests - Serology

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Protocol Number
    Description

    Protocol Number

    Type de données

    integer

    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Visit
    Description

    Visit

    Type de données

    text

    Blood Sample for Antibodies to CS
    Description

    Blood Sample for Antibodies to CS

    Has a blood sample been taken for antibodies to CS?
    Description

    For Cohort 2 only from Malaria-026

    Type de données

    boolean

    Date sample taken
    Description

    Date sample taken

    Type de données

    date

    Blood Sample for Antibodies to HBs
    Description

    Blood Sample for Antibodies to HBs

    Has a blood sample been taken for antibodies to HBs?
    Description

    For Cohort 2 only from Malaria-026

    Type de données

    text

    Date sample taken
    Description

    Date sample taken

    Type de données

    date

    Blood Sample for Hematocrit
    Description

    Blood Sample for Hematocrit

    Has a blood sample been taken for hematocrit?
    Description

    Has a blood sample been taken for hematocrit?

    Type de données

    boolean

    Date sample taken
    Description

    Date sample taken

    Type de données

    date

    Test
    Description

    Test

    PCV (Packed cell volume) / Hematocrit
    Description

    PCV (Packed cell volume) / Hematocrit

    Type de données

    text

    Results
    Description

    Results

    Type de données

    float

    Unités de mesure
    • %
    %
    Out of range values
    Description

    Out of range values

    Type de données

    integer

    If Other, please specify
    Description

    If Other, please specify

    Type de données

    text

    Retour au début de la page

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    Visit 2: Laboratory Tests - Serology

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    Protocol Number
    Item
    Protocol Number
    integer
    Subject Number
    Item
    Subject Number
    integer
    Item
    Visit
    text
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    Code List
    Visit
    CL Item
    Visit 2, Study month 33 (33 months post dose 1 in Malaria-026, 12 months after visit 1) (1)
    Item Group
    Blood Sample for Antibodies to CS
    Has a blood sample been taken for antibodies to CS?
    Item
    Has a blood sample been taken for antibodies to CS?
    boolean
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Blood Sample for Antibodies to HBs
    Item
    Has a blood sample been taken for antibodies to HBs?
    text
    Has a blood sample been taken for antibodies to HBs?
    Code List
    Has a blood sample been taken for antibodies to HBs?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA (for Cohort 1) (3)
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Blood Sample for Hematocrit
    Has a blood sample been taken for hematocrit?
    Item
    Has a blood sample been taken for hematocrit?
    boolean
    Date sample taken
    Item
    Date sample taken
    date
    Item Group
    Test
    Item
    PCV (Packed cell volume) / Hematocrit
    text
    PCV (Packed cell volume) / Hematocrit
    Code List
    PCV (Packed cell volume) / Hematocrit
    CL Item
    Done (1)
    CL Item
    Not done (2)
    Results
    Item
    Results
    float
    Item
    Out of range values
    integer
    Out of range values
    Code List
    Out of range values
    CL Item
    Laboratory error (1)
    CL Item
    Preexisting/concomitant medical condition, please specify in table above (2)
    CL Item
    Prior/Concomitant Medication (3)
    CL Item
    Child is well - not investigated further (4)
    CL Item
    Other (5)
    If Other, please specify
    Item
    If Other, please specify
    text
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