0 Ratings
ID

27210

Description

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 GSK’s Clinical Study Register is no longer maintained for this study.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

Keywords

Versions (2)
  1. 10/26/17 10/26/17 -
  2. 11/3/17 11/3/17 -
Copyright Holder

Pfizer

Uploaded on

November 3, 2017

DOI

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License

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

    English

    Workbook 1 Visit 3

    1 forms  
    1. StudyEvent: ODM
      1. Workbook 1 Visit 3
    Administrative Documentation
    Description

    Administrative Documentation

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

    Subject Number

    Data type

    integer

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

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Return of diary card
    Description

    Return

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0018700 (Health Diaries)
    UMLS CUI [1,2]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    Study Continuation
    Description

    Study Continuation

    Alias
    UMLS CUI-1
    C0008972 (Clinical Research)
    UMLS CUI-2
    C0805733 (Continuation status)
    LOINC
    MTHU008303
    Did the subject come at visit 3?
    Description

    Subject return to visit

    Data type

    text

    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.
    Description

    Reason no study continuation

    Data type

    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
    Description

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

    Data type

    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
    Description

    Decision

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679006 (Decision)
    Back to the top of the page

    Similar models

    Workbook 1 Visit 3

    1 forms
    1. StudyEvent: ODM
      1. Workbook 1 Visit 3
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Return
    Item
    Return of diary card
    text
    C0018700 (UMLS CUI [1,1])
    C0332156 (UMLS CUI [1,2])
    Item Group
    Study Continuation
    C0008972 (UMLS CUI-1)
    C0805733 (UMLS CUI-2)
    Item
    Did the subject come at visit 3?
    text
    C0545082 (UMLS CUI [1,1])
    C0805733 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    Subject return to visit
    Code List
    Did the subject come at visit 3?
    CL Item
    Yes (Please complete the date of visit) (Yes (Please complete the date of visit))
    CL Item
    No (Please complete below) (No (Please complete below))
    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)
    CL Item
    Same reason and decision as previous visit (SAM)
    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)
    Back to the top of the page 

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