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ID

36613

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

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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

    Concomitant Vaccination

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Clinical Trial Subject Unique Identifier

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C2347852
    UMLS CUI-2
    C0042196
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Description

    Concomitant Agent, Vaccination

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0042196
    Trade / (Generic) Name
    Description

    Concomitant Agent, Vaccination, Medication name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C2360065
    Route
    Description

    Concomitant Agent, Vaccination, Drug Administration Routes

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0013153
    Administration date
    Description

    Concomitant Agent, Vaccination, Date in time

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0011008
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    Similar models

    Concomitant Vaccination

    1 forms
    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
    Concomitant Vaccination
    C2347852 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    Concomitant Agent, Vaccination
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Concomitant Agent, Vaccination, Medication name
    Item
    Trade / (Generic) Name
    text
    C2347852 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C2360065 (UMLS CUI [1,3])
    Concomitant Agent, Vaccination, Drug Administration Routes
    Item
    Route
    text
    C2347852 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    Concomitant Agent, Vaccination, Date in time
    Item
    Administration date
    date
    C2347852 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
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