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ID

36761

Beschreibung

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 form includes the reference ranges of the laboratory tests and is hence not related to a particular subject's visit.

Link

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

Stichworte

Versionen (3)
  1. 11.12.18 11.12.18 -
  2. 05.06.19 05.06.19 -
  3. 06.06.19 06.06.19 -
Rechteinhaber

GSK group of companies

Hochgeladen am

6. Juni 2019

DOI

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Lizenz

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

    Englisch

    Laboratory Reference Ranges

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre
    Beschreibung

    Centre

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Laboratory Name
    Beschreibung

    Laboratory Name

    Alias
    UMLS CUI-1
    C3258037
    Lab code
    Beschreibung

    for internal use only

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0805701
    Laboratory name
    Beschreibung

    Laboratory name

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3258037
    Laboratory Tests Reference Ranges
    Beschreibung

    Laboratory Tests Reference Ranges

    Alias
    UMLS CUI-1
    C0883335
    Lower limit of age range
    Beschreibung

    prefilled with "4"

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1514721
    UMLS CUI [1,3]
    C0439081
    Upper limit of age range
    Beschreibung

    prefilled with "110"

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1514721
    UMLS CUI [1,3]
    C0439085
    Age units
    Beschreibung

    Preselected: 1 = "years"

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0001779
    UMLS CUI [1,2]
    C1519795
    Sex
    Beschreibung

    Preselected: "B" = "Male and female reference range"

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Date these reference ranges became effective:
    Beschreibung

    prefilled with "01-MAR-2015"

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0883335
    PCV (Packed cell volume) Hematocrit: Unit
    Beschreibung

    PCV (Packed cell volume) / Hematocrit belongs to "Haematology"

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0518014
    UMLS CUI [1,2]
    C1519795
    Low reference value
    Beschreibung

    Hematocrit: Lower limit of reference range

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C1272773
    UMLS CUI [1,2]
    C0518014
    High reference value
    Beschreibung

    Hematocrit: Upper limit of reference range

    Datentyp

    float

    Alias
    UMLS CUI [1,1]
    C1299400
    UMLS CUI [1,2]
    C0518014
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Laboratory Reference Ranges

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Centre
    Item
    Centre
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Laboratory Name
    C3258037 (UMLS CUI-1)
    Lab code
    Item
    Lab code
    text
    C0022877 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    Laboratory name
    Item
    Laboratory name
    text
    C3258037 (UMLS CUI [1])
    Item Group
    Laboratory Tests Reference Ranges
    C0883335 (UMLS CUI-1)
    Lower limit of age range
    Item
    Lower limit of age range
    integer
    C0001779 (UMLS CUI [1,1])
    C1514721 (UMLS CUI [1,2])
    C0439081 (UMLS CUI [1,3])
    Upper limit of age range
    Item
    Upper limit of age range
    integer
    C0001779 (UMLS CUI [1,1])
    C1514721 (UMLS CUI [1,2])
    C0439085 (UMLS CUI [1,3])
    Item
    Age units
    integer
    C0001779 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Age units
    Code List
    Age units
    CL Item
    years (1)
    CL Item
    months (2)
    CL Item
    weeks (3)
    CL Item
    days (4)
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Male reference range (M)
    CL Item
    Female reference range (F)
    CL Item
    Male and female reference range (B)
    Start date of these reference ranges
    Item
    Date these reference ranges became effective:
    date
    C0808070 (UMLS CUI [1,1])
    C0883335 (UMLS CUI [1,2])
    Hematocrit: Unit
    Item
    PCV (Packed cell volume) Hematocrit: Unit
    text
    C0518014 (UMLS CUI [1,1])
    C1519795 (UMLS CUI [1,2])
    Hematocrit: Lower limit of reference range
    Item
    Low reference value
    float
    C1272773 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Hematocrit: Upper limit of reference range
    Item
    High reference value
    float
    C1299400 (UMLS CUI [1,1])
    C0518014 (UMLS CUI [1,2])
    Zum Seitenanfang zurückkehren 

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