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ID

26865

Beschrijving

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Trefwoorden

Versies (2)
  1. 26-10-17 26-10-17 -
  2. 03-11-17 03-11-17 -
Houder van rechten

Pfizer

Geüploaded op

26 oktober 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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    Meningococcal Infections Vaccination in children NCT00196976

    Engels

    Visit 2 Part 1

    1 Formulieren  
    1. StudyEvent: ODM
      1. Visit 2 Part 1
    Administrative Documentation
    Beschrijving

    Administrative Documentation

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

    Subject Number

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Date of visit
    Beschrijving

    Date of visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Study Continuation
    Beschrijving

    Study Continuation

    Alias
    UMLS CUI-1
    C0008972 (Clinical Research)
    UMLS CUI-2
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Did the subject come at visit 2 ?
    Beschrijving

    Subject return to visit

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    UMLS CUI [1,3]
    C0008976 (Clinical Trials)
    SNOMED
    110465008
    LOINC
    LP231796-6
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    Beschrijving

    Reason no study continuation

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
    Beschrijving

    Serious adverse event Number | Unsolicited Adverse Event Number | Solicited Adverse Event code

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C0805701 (Code)
    UMLS CUI [1,3]
    C1521902 (To specify)
    UMLS CUI [2,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [2,2]
    C0805701 (Code)
    UMLS CUI [2,3]
    C1521902 (To specify)
    Please tick who took the decision
    Beschrijving

    Decision

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0679006 (Decision)
    LABORATORY TESTS; BLOOD SAMPLE
    Beschrijving

    LABORATORY TESTS; BLOOD SAMPLE

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Has a blood sample been taken ?
    Beschrijving

    Blood sample taken

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    Please complete only if different from visit date:
    Beschrijving

    Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0005834 (Collection of blood specimen for laboratory procedure)
    SNOMED
    82078001
    LOINC
    LP125037-4
    Terug naar het begin van de pagina

    Similar models

    Visit 2 Part 1

    1 Formulieren
    1. StudyEvent: ODM
      1. Visit 2 Part 1
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Documentation
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Date of visit
    Item
    Date of visit
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Study Continuation
    C0008972 (UMLS CUI-1)
    C0805733 (UMLS CUI-2)
    Subject return to visit
    Item
    Did the subject come at visit 2 ?
    boolean
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Item
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    text
    C0008972 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    Reason no visit
    Code List
    Please tick the ONE most appropriate reason and skip the following pages of this visit.
    CL Item
    Serious adverse event (complete the Serious Adverse Event form) (SAE)
    CL Item
    Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (OTH)
    Serious adverse event Number | Unsolicited Adverse Event Number | Solicited Adverse Event code
    Item
    Please specify SAE N°; Please specify unsolicited AE N° or solicited AE code
    integer
    C1519255 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    C0877248 (UMLS CUI [2,1])
    C0805701 (UMLS CUI [2,2])
    C1521902 (UMLS CUI [2,3])
    Item
    Please tick who took the decision
    text
    C0679006 (UMLS CUI [1])
    Decision
    Code List
    Please tick who took the decision
    CL Item
    Investigator (I)
    CL Item
    Parents/Guardians (P)
    Item Group
    LABORATORY TESTS; BLOOD SAMPLE
    C0022885 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    Blood sample taken
    Item
    Has a blood sample been taken ?
    boolean
    C1277698 (UMLS CUI [1])
    Date
    Item
    Please complete only if different from visit date:
    date
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    Terug naar het begin van de pagina 

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