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ID

36761

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 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.

Lien

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

Mots-clés

Versions (3)
  1. 11/12/2018 11/12/2018 -
  2. 05/06/2019 05/06/2019 -
  3. 06/06/2019 06/06/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

6 juin 2019

DOI

Pour une demande vous connecter.

Licence

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

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    Laboratory Reference Ranges

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Centre
    Description

    Centre

    Type de données

    text

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

    Laboratory Name

    Alias
    UMLS CUI-1
    C3258037
    Lab code
    Description

    for internal use only

    Type de données

    text

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

    Laboratory name

    Type de données

    text

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

    Laboratory Tests Reference Ranges

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

    prefilled with "4"

    Type de données

    integer

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

    prefilled with "110"

    Type de données

    integer

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

    Preselected: 1 = "years"

    Type de données

    integer

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

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

    Type de données

    text

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

    prefilled with "01-MAR-2015"

    Type de données

    date

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

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

    Type de données

    text

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

    Hematocrit: Lower limit of reference range

    Type de données

    float

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

    Hematocrit: Upper limit of reference range

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C1299400
    UMLS CUI [1,2]
    C0518014
    Retour au début de la page

    Similar models

    Laboratory Reference Ranges

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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