ID

44613

Beskrivning

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 This study (Malaria-039 / NCT00323622 / GlaxoSmithKline Study ID 104297) is a two-year follow-up to Malaria-026 and consists of three clinic visits: Visit 1 / Informed Consent Visit at Visit 7 of Malaria-026 (i.e. 21 months post vaccine dose 1 in Malaria-026). Visit 2 / Interim Analysis 12 months +/- 1 month after Visit 1. Visit 3 / Final Analysis 24 months +/- 1 month after Visit 1. See https://clinicaltrials.gov/ct2/show/NCT00323622 This document is to be completed at Visit 2.

Länk

https://clinicaltrials.gov/ct2/show/NCT00323622

Nyckelord

Versioner (4)
  1. 2018-12-11 2018-12-11 -
  2. 2019-06-06 2019-06-06 -
  3. 2019-06-12 2019-06-12 -
  4. 2021-09-27 2021-09-27 -
Rättsinnehavare

GSK group of companies

Uppladdad den

27 september 2021

DOI

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Licens

Creative Commons BY-NC 3.0
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    Immunogenicity of malaria vaccine candidate - NCT00323622 / Malaria-039

    Engelsk

    Visit 2: Laboratory Tests

    1 Formulär  
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Beskrivning

    Date of Visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Blood Sample for Antibodies to CS
    Beskrivning

    Blood Sample for Antibodies to CS

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C3833453
    UMLS CUI-3
    C0525913
    Has a blood sample been taken for antibodies to CS?
    Beskrivning

    For Cohorts 1 and 2 from Malaria-026

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C3833453
    UMLS CUI [1,3]
    C0525913
    Date CS antibody sample taken
    Beskrivning

    if applicable; please complete only if different from visit date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    UMLS CUI [2,1]
    C3833453
    UMLS CUI [2,2]
    C0525913
    Blood Sample for Antibodies to HBs
    Beskrivning

    Blood Sample for Antibodies to HBs

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0201478
    Has a blood sample been taken for antibodies to HBs?
    Beskrivning

    For Cohort 2 only from Malaria-026

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0201478
    Date anti-HBs sample taken
    Beskrivning

    if applicable; please complete only if different from visit date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0201478
    Blood Sample for Hematocrit
    Beskrivning

    Blood Sample for Hematocrit

    Alias
    UMLS CUI-1
    C0005834
    UMLS CUI-2
    C0518014
    Has a blood sample been taken for hematocrit?
    Beskrivning

    blood sample taken for hematocrit

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0518014
    Date hematocrit sample taken
    Beskrivning

    if applicable, please complete only if different from visit date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0518014
    Has PCV (Packed cell volume) / Hematocrit test been done?
    Beskrivning

    Hematocrit test done

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0518014
    UMLS CUI [1,2]
    C0884358
    PCV (Packed cell volume) / Hematocrit Results
    Beskrivning

    if test was done

    Datatyp

    float

    Måttenheter
    • %
    Alias
    UMLS CUI [1]
    C0518014
    %
    Out of range values
    Beskrivning

    if applicable; please enter ONE code

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0438215
    UMLS CUI [1,2]
    C0600091
    specify out of range values
    Beskrivning

    specification of out of range values

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348235
    UMLS CUI [1,2]
    C0438215
    Tillbaka till toppen

    Similar models

    Visit 2: Laboratory Tests

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Blood Sample for Antibodies to CS
    C0005834 (UMLS CUI-1)
    C3833453 (UMLS CUI-2)
    C0525913 (UMLS CUI-3)
    blood sample taken for antibodies to CS
    Item
    Has a blood sample been taken for antibodies to CS?
    boolean
    C1277698 (UMLS CUI [1,1])
    C3833453 (UMLS CUI [1,2])
    C0525913 (UMLS CUI [1,3])
    Date CS antibody sample taken
    Item
    Date CS antibody sample taken
    date
    C1302413 (UMLS CUI [1])
    C3833453 (UMLS CUI [2,1])
    C0525913 (UMLS CUI [2,2])
    Item Group
    Blood Sample for Antibodies to HBs
    C0005834 (UMLS CUI-1)
    C0201478 (UMLS CUI-2)
    Item
    Has a blood sample been taken for antibodies to HBs?
    text
    C1277698 (UMLS CUI [1,1])
    C0201478 (UMLS CUI [1,2])
    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 anti-HBs sample taken
    Item
    Date anti-HBs sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0201478 (UMLS CUI [1,2])
    Item Group
    Blood Sample for Hematocrit
    C0005834 (UMLS CUI-1)
    C0518014 (UMLS CUI-2)
    blood sample taken for hematocrit
    Item
    Has a blood sample been taken for hematocrit?
    boolean
    C1277698 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Date hematocrit sample taken
    Item
    Date hematocrit sample taken
    date
    C1302413 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Hematocrit test done
    Item
    Has PCV (Packed cell volume) / Hematocrit test been done?
    boolean
    C0518014 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Hematocrit
    Item
    PCV (Packed cell volume) / Hematocrit Results
    float
    C0518014 (UMLS CUI [1])
    Item
    Out of range values
    integer
    C0438215 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Out of range values
    Code List
    Out of range values
    CL Item
    Laboratory error (1)
    CL Item
    Preexisting/concomitant medical condition, please specify (2)
    CL Item
    Prior/Concomitant Medication (3)
    CL Item
    Child is well - not investigated further (4)
    CL Item
    Other, please specify (5)
    specification of out of range values
    Item
    specify out of range values
    text
    C2348235 (UMLS CUI [1,1])
    C0438215 (UMLS CUI [1,2])
    Tillbaka till toppen 

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