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 GSK’s Clinical Study Register is no longer maintained for this study.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

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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 (Administrative documentation)
    SNOMED
    405624007
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    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 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI [1,2]
    C2347852 (Concomitant Agent)
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196 (Vaccination)
    SNOMED
    33879002
    LOINC
    LP29692-8
    UMLS CUI-2
    C2347852 (Concomitant Agent)
    Trade / (Generic) Name
    Description

    Trade name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    UMLS CUI [1,2]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    Administration date
    Description

    Administration date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734 (Administration procedure)
    SNOMED
    416118004
    LOINC
    LA20296-2
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    For GSK
    Description

    Investigator Use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,2]
    C0457083 (Usage)
    SNOMED
    277889008
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Have any medications/treatments been administered during study period?
    Description

    Concomitant Medication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2347852 (Concomitant Agent)
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Trade/Generic Name
    Description

    Trade/Generic Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Medical indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298 (Indication)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Total daily dose
    Description

    Daily dose

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348070 (Daily Dose)
    Route
    Description

    Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013153 (Drug Administration Routes)
    SNOMED
    410675002
    LOINC
    LP40261-7
    Start date
    Description

    Start date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    End date
    Description

    End date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    tick box if continuing at end of study
    Description

    Continuing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666 (Concomitant Medication Ongoing)
    For GSK
    Description

    Investigator Use

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0008961 (Clinical Investigators)
    UMLS CUI [1,2]
    C0457083 (Usage)
    SNOMED
    277889008
    Back to the top of the page

    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])
    Back to the top of the page 

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