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ID

36614

Description

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

Keywords

Versions (1)
  1. 5/26/19 5/26/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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    DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants; NCT00320463

    English

    Medication

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

    Administrative Data

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

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Have any medications/treatments been administered during study period?
    Description

    Pharmaceutical Preparations

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Trade / Generic Name
    Description

    Pharmaceutical Preparations, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C2360065 (Medication name)
    LOINC
    MTHU027854
    Medical Indication
    Description

    Pharmaceutical Preparations, Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C3146298 (Indication)
    Total daily dose
    Description

    Pharmaceutical Preparations, Daily Dose, Total

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C2348070 (Daily Dose)
    UMLS CUI [1,3]
    C0439810 (Total)
    SNOMED
    255619001
    LOINC
    LP21089-5
    Route
    Description

    Pharmaceutical Preparations, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Start Date
    Description

    Pharmaceutical Preparations, Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0808070 (Start Date)
    End Date
    Description

    Pharmaceutical Preparations, End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Tick box if continuing at end of study
    Description

    Pharmaceutical Preparations, Continuous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0549178 (Continuous)
    SNOMED
    255238004
    LOINC
    LA16902-1
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    Similar models

    Medication

    1 forms
    1. StudyEvent: ODM
      1. Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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