0 Ratings
ID

27205

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 GSK’s Clinical Study Register is no longer maintained for this study.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

    1 forms  
    Administrative Documentation
    Description

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Vaccination
    Description

    Concomitant Vaccination

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

    Concomitant vaccination

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade / (Generic) Name
    Description

    Trade name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Administration date
    Description

    Administration date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    For GSK
    Description

    Investigator Use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0457083
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Have any medications/treatments been administered during study period?
    Description

    Concomitant Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227
    Trade/Generic Name
    Description

    Trade/Generic Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227
    Medical indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Total daily dose
    Description

    Daily dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348070
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153
    Start date
    Description

    Start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0013227
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C0013227
    tick box if continuing at end of study
    Description

    Continuing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    For GSK
    Description

    Investigator Use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0457083
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    Similar models

    Workbook 1 Other medical information

    1 forms
    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])
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
    text
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Concomitant vaccination
    Code List
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol ?
    CL Item
    No (No)
    CL Item
    Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine (Yes, please record concomitant vaccination with trade name and / or generic name, route and vaccine)
    CL Item
    administration date. (administration date.)
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Trade name
    Item
    Trade / (Generic) Name
    text
    C0013227 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Investigator Use
    Item
    For GSK
    text
    C0008961 (UMLS CUI [1,1])
    C0457083 (UMLS CUI [1,2])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Item
    Have any medications/treatments been administered during study period?
    text
    C2347852 (UMLS CUI [1])
    Concomitant Medication
    Code List
    Have any medications/treatments been administered during study period?
    CL Item
    No (No)
    CL Item
    Yes, please complete the following table. (Yes, please complete the following table.)
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    Trade/Generic Name
    Item
    Trade/Generic Name
    text
    C0013227 (UMLS CUI [1])
    Item
    Medical indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Indication
    Code List
    Medical indication
    CL Item
    Specify (Specify)
    CL Item
    Prophylactic (Prophylactic)
    Daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1])
    Route
    Item
    Route
    text
    C0013153 (UMLS CUI [1])
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    End date
    Item
    End date
    date
    C0806020 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Continuing
    Item
    tick box if continuing at end of study
    boolean
    C2826666 (UMLS CUI [1])
    Investigator Use
    Item
    For GSK
    text
    C0008961 (UMLS CUI [1,1])
    C0457083 (UMLS CUI [1,2])
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