0 Avaliações

ID

41659

Descrição

Study ID: 105874 Clinical Study ID: 105874 Study Title: Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00307021 https://clinicaltrials.gov/ct2/show/NCT00307021 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049 Trade Name: N/A Study Indication: Malaria This study has a total of 7 visits. Visit 1 = Screening, Visits 2-6 are during the double-blind phase (Month 0-3) and Visit 7 is during the single-blind phase (Month 4-14). This form (Screening) is to be filled out at Visit 1 (Day -28 to day 0). Informed Consent has to be obtained prior to any study procedure.

Link

https://clinicaltrials.gov/ct2/show/NCT00307021

Palavras-chave

  1. 01/12/2020 01/12/2020 -
  2. 05/12/2020 05/12/2020 -
Titular dos direitos

GlaxoSmithKline

Transferido a

5 de dezembro de 2020

DOI

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Licença

Creative Commons BY-NC 4.0

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    Safety & Immunogenicity of two GSK Biologicals' Candidate Malaria Vaccines in young children, NCT00307021

    1. StudyEvent: ODM
      1. Screening
    Administrative Data
    Descrição

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Centre number
    Descrição

    Centre number

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Subject number
    Descrição

    Subject number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2348585
    Treatment number
    Descrição

    Treatment number

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1522541
    Date of visit
    Descrição

    Date of visit

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C1320303
    Informed Consent
    Descrição

    Informed Consent

    Alias
    UMLS CUI-1
    C0021430
    I certify that Informed Consent has been obtained prior to any study procedure.
    Descrição

    Informed Consent obtained prior to study

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C2347804
    Informed Consent Date
    Descrição

    Informed Consent Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0021430
    UMLS CUI [1,2]
    C0011008
    Demographics
    Descrição

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Descrição

    Date of birth

    Tipo de dados

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Descrição

    Gender

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Descrição

    Ethnicity

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Race: African / African American
    Descrição

    Race: African / African American

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0085756
    UMLS CUI [2]
    C0027567
    Race: American Indian or Alaskan Native
    Descrição

    Race: American Indian or Alaskan Native

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1515945
    Race: Asian - Central/South Asian Heritage
    Descrição

    Race: Asian - Central/South Asian Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0238696
    UMLS CUI [2]
    C1519427
    Race: Asian - East Asian Heritage
    Descrição

    Race: Asian - East Asian Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C4540996
    Race: Asian - Japanese Heritage
    Descrição

    Race: Asian - Japanese Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1556094
    Race: Asian - South East Asian Heritage
    Descrição

    Race: Asian - South East Asian Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0238697
    Race: Native Hawaiian or Other Pacific Islander
    Descrição

    Race: Native Hawaiian or Other Pacific Islander

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513907
    Race: White - Arabic / North African Heritage
    Descrição

    Race: White - Arabic / North African Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0238604
    UMLS CUI [2]
    C2698217
    Race: White - Caucasian / European Heritage
    Descrição

    Race: White - Caucasian / European Heritage

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0043157
    Other Race, specify
    Descrição

    Other Race

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394

    Similar models

    1. StudyEvent: ODM
      1. Screening
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Centre number
    Item
    Centre number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Subject number
    Item
    Subject number
    text
    C2348585 (UMLS CUI [1])
    Treatment number
    Item
    Treatment number
    text
    C1522541 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Informed Consent
    C0021430 (UMLS CUI-1)
    Informed Consent obtained prior to study
    Item
    I certify that Informed Consent has been obtained prior to any study procedure.
    boolean
    C0021430 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C2347804 (UMLS CUI [1,3])
    Informed Consent Date
    Item
    Informed Consent Date
    date
    C0021430 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Demographics
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Code List
    Ethnicity
    CL Item
    American Hispanic or Latino (1)
    CL Item
    Not American Hispanic or Latino (2)
    Race: African / African American
    Item
    Race: African / African American
    boolean
    C0085756 (UMLS CUI [1])
    C0027567 (UMLS CUI [2])
    Race: American Indian or Alaskan Native
    Item
    Race: American Indian or Alaskan Native
    boolean
    C1515945 (UMLS CUI [1])
    Race: Asian - Central/South Asian Heritage
    Item
    Race: Asian - Central/South Asian Heritage
    boolean
    C0238696 (UMLS CUI [1])
    C1519427 (UMLS CUI [2])
    Race: Asian - East Asian Heritage
    Item
    Race: Asian - East Asian Heritage
    boolean
    C4540996 (UMLS CUI [1])
    Race: Asian - Japanese Heritage
    Item
    Race: Asian - Japanese Heritage
    boolean
    C1556094 (UMLS CUI [1])
    Race: Asian - South East Asian Heritage
    Item
    Race: Asian - South East Asian Heritage
    boolean
    C0238697 (UMLS CUI [1])
    Race: Native Hawaiian or Other Pacific Islander
    Item
    Race: Native Hawaiian or Other Pacific Islander
    boolean
    C1513907 (UMLS CUI [1])
    Race: White - Arabic / North African Heritage
    Item
    Race: White - Arabic / North African Heritage
    boolean
    C0238604 (UMLS CUI [1])
    C2698217 (UMLS CUI [2])
    Race: White - Caucasian / European Heritage
    Item
    Race: White - Caucasian / European Heritage
    boolean
    C0043157 (UMLS CUI [1])
    Other Race
    Item
    Other Race, specify
    text
    C0034510 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])

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