0 Ratings
ID

26863

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 GSK’s Clinical Study Register is no longer maintained for this study.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 (1)
  1. 10/26/17 10/26/17 -
Copyright Holder

Pfizer

Uploaded on

October 26, 2017

DOI

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License

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

    English

    Visit 2 Part 1

    1 forms  
    1. StudyEvent: ODM
      1. Visit 2 Part 1
    Administrative Documentation
    Description

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Date of visit
    Description

    Date of visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Study Continuation
    Description

    Study Continuation

    Alias
    UMLS CUI-1
    C0008972
    UMLS CUI-2
    C0805733
    Did the subject come at visit 2 ?
    Description

    Subject return to visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0805733
    UMLS CUI [1,3]
    C0008976
    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
    UMLS CUI [1,2]
    C0805733
    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
    UMLS CUI [1,2]
    C0805701
    UMLS CUI [1,3]
    C1521902
    UMLS CUI [2,1]
    C0877248
    UMLS CUI [2,2]
    C0805701
    UMLS CUI [2,3]
    C1521902
    Please tick who took the decision
    Description

    Decision

    Data type

    text

    Alias
    UMLS CUI [1]
    C0679006
    LABORATORY TESTS; BLOOD SAMPLE
    Description

    LABORATORY TESTS; BLOOD SAMPLE

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0005834
    Has a blood sample been taken ?
    Description

    Blood sample taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1277698
    Please complete only if different from visit date:
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005834
    Back to the top of the page

    Similar models

    Visit 2 Part 1

    1 forms
    1. StudyEvent: ODM
      1. Visit 2 Part 1
    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])
    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])
    Back to the top of the page 

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