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ID

36623

Beskrivning

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

Nyckelord

Versioner (1)
  1. 2019-05-26 2019-05-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 maj 2019

DOI

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Licens

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

    Engelsk

    Visit 4

    1 Formulär  
    1. StudyEvent: ODM
      1. Visit 4
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Date of visit
    Beskrivning

    Date of visit

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Number
    Beskrivning

    Clinical Trial Subject Unique Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Check for Study Continuation
    Beskrivning

    Check for Study Continuation

    Alias
    UMLS CUI-1
    C0805733
    UMLS CUI-2
    C0008976
    Did the subject return for visit 4 ?
    Beskrivning

    Continuation status, Clinical Trials

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Beskrivning

    Continuation status, Clinical Trials, Reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Specify
    Beskrivning

    Continuation status, Clinical Trials, Reason

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0566251
    Please tick who made the decision
    Beskrivning

    Continuation status, Clinical Trials, Decision

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0805733
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [1,3]
    C0679006
    Laboratory Tests - Blood Sample
    Beskrivning

    Laboratory Tests - Blood Sample

    Alias
    UMLS CUI-1
    C0005834
    Has a blood sample been taken ?
    Beskrivning

    Collection of blood specimen for laboratory procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Date (Please complete only if different from visit date)
    Beskrivning

    Collection of blood specimen for laboratory procedure, Date in time

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    Tillbaka till toppen

    Similar models

    Visit 4

    1 Formulär
    1. StudyEvent: ODM
      1. Visit 4
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Clinical Trial Subject Unique Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Check for Study Continuation
    C0805733 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    Continuation status, Clinical Trials
    Item
    Did the subject return for visit 4 ?
    boolean
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    Item
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse event (Please specify SAE No.) (1)
    CL Item
    Non-Serious adverse event (Please specify AE No. or solicited AE code) (2)
    CL Item
    Other, please specify (3)
    Item
    Specify
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0566251 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Specify
    Item
    Please tick who made the decision
    text
    C0805733 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0679006 (UMLS CUI [1,3])
    Continuation status, Clinical Trials, Reason
    Code List
    Please tick who made the decision
    CL Item
    Investigator  (1)
    CL Item
    Parents/Guardians (2)
    Item Group
    Laboratory Tests - Blood Sample
    C0005834 (UMLS CUI-1)
    Collection of blood specimen for laboratory procedure
    Item
    Has a blood sample been taken ?
    boolean
    C0005834 (UMLS CUI [1])
    Collection of blood specimen for laboratory procedure, Date in time
    Item
    Date (Please complete only if different from visit date)
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Tillbaka till toppen 

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