0 Ratings
ID

41659

Description

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

Keywords

Versions (2)
  1. 12/1/20 12/1/20 -
  2. 12/5/20 12/5/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 5, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

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

    English

    Screening

    1 forms  
    1. StudyEvent: ODM
      1. Screening
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Centre number
    Description

    Centre number

    Data type

    text

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

    Subject number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Treatment number
    Description

    Treatment number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1522541
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Informed Consent
    Description

    Informed Consent

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

    Informed Consent obtained prior to study

    Data type

    boolean

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

    Informed Consent Date

    Data type

    date

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

    Demographics

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Description

    Ethnicity

    Data type

    integer

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

    Race: African / African American

    Data type

    boolean

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

    Race: American Indian or Alaskan Native

    Data type

    boolean

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

    Race: Asian - Central/South Asian Heritage

    Data type

    boolean

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

    Race: Asian - East Asian Heritage

    Data type

    boolean

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

    Race: Asian - Japanese Heritage

    Data type

    boolean

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

    Race: Asian - South East Asian Heritage

    Data type

    boolean

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

    Race: Native Hawaiian or Other Pacific Islander

    Data type

    boolean

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

    Race: White - Arabic / North African Heritage

    Data type

    boolean

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

    Race: White - Caucasian / European Heritage

    Data type

    boolean

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

    Other Race

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0034510
    UMLS CUI [1,2]
    C0205394
    Back to the top of the page

    Similar models

    Screening

    1 forms
    1. StudyEvent: ODM
      1. Screening
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Gender
    Code List
    Gender
    CL Item
    Male (M)
    CL Item
    Female (F)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial