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ID

36774

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 is to be completed at Visit 3.

Lien

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

Mots-clés

  1. 12/12/2018 12/12/2018 -
  2. 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

    Visit 3: Physical Examination

    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of Visit
    Description

    Date of Visit

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809 (Physical Examination)
    SNOMED
    5880005
    LOINC
    MTHU028014
    Body Weight
    Description

    Body Weight

    Type de données

    float

    Unités de mesure
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Temperature
    Description

    Temperature

    Type de données

    float

    Unités de mesure
    • °C
    Alias
    UMLS CUI [1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    °C
    Route
    Description

    Route

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0005903 (Body Temperature)
    SNOMED
    722490005
    LOINC
    LP36617-6
    UMLS CUI [1,2]
    C1515974 (Anatomic Site)

    Similar models

    Visit 3: Physical Examination

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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
    Physical Examination
    C0031809 (UMLS CUI-1)
    Body Weight
    Item
    Body Weight
    float
    C0005910 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Item
    Route
    integer
    C0005903 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Code List
    Route
    CL Item
    oral (1)
    CL Item
    axillary (2)
    CL Item
    rectal (3)

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