0 Ratings
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.

Link

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

Keywords

Versions (2)
  1. 12/12/18 12/12/18 -
  2. 6/6/19 6/6/19 -
Copyright Holder

GSK group of companies

Uploaded on

June 6, 2019

DOI

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License

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

    English

    Visit 3: Physical Examination

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Physical Examination
    Description

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Body Weight
    Description

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Route
    Description

    Route

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1515974
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    Similar models

    Visit 3: Physical Examination

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Route
    Code List
    Route
    CL Item
    oral (1)
    CL Item
    axillary (2)
    CL Item
    rectal (3)
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