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ID

36614

Beschrijving

Study ID: 105910 Clinical Study ID: 105910 Study Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00320463 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: DTPa-HBV-IPV/Hib vaccine Trade Name: N/A Study Indication: Diphtheria, Hepatitis B, Poliomyelitis, Tetanus, Whooping Cough

Trefwoorden

  1. 26-05-19 26-05-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 mei 2019

DOI

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Licentie

Creative Commons BY-NC 3.0

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    DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

    1. StudyEvent: ODM
      1. Medication
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Medication
    Beschrijving

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered during study period?
    Beschrijving

    Pharmaceutical Preparations

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    Trade / Generic Name
    Beschrijving

    Pharmaceutical Preparations, Medication name

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2360065
    Medical Indication
    Beschrijving

    Pharmaceutical Preparations, Indication

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C3146298
    Total daily dose
    Beschrijving

    Pharmaceutical Preparations, Daily Dose, Total

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C2348070
    UMLS CUI [1,3]
    C0439810
    Route
    Beschrijving

    Pharmaceutical Preparations, Drug Administration Routes

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0013153
    Start Date
    Beschrijving

    Pharmaceutical Preparations, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End Date
    Beschrijving

    Pharmaceutical Preparations, End Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Tick box if continuing at end of study
    Beschrijving

    Pharmaceutical Preparations, Continuous

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0549178

    Similar models

    Medication

    1. StudyEvent: ODM
      1. Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Pharmaceutical Preparations
    Item
    Have any medications/treatments been administered during study period?
    boolean
    C0013227 (UMLS CUI [1])
    Pharmaceutical Preparations, Medication name
    Item
    Trade / Generic Name
    text
    C0013227 (UMLS CUI [1,1])
    C2360065 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Indication
    Item
    Medical Indication
    text
    C0013227 (UMLS CUI [1,1])
    C3146298 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Daily Dose, Total
    Item
    Total daily dose
    text
    C0013227 (UMLS CUI [1,1])
    C2348070 (UMLS CUI [1,2])
    C0439810 (UMLS CUI [1,3])
    Pharmaceutical Preparations, Drug Administration Routes
    Item
    Route
    text
    C0013227 (UMLS CUI [1,1])
    C0013153 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Start Date
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Pharmaceutical Preparations, End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Pharmaceutical Preparations, Continuous
    Item
    Tick box if continuing at end of study
    boolean
    C0013227 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])

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