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ID

32982

Description

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

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Versions (1)
  1. 2018-11-22 2018-11-22 -
Copyright Holder

GSK group of companies

Uploaded on

22 november 2018

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Creative Commons BY-NC 3.0
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    Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

    English

    Elimination Criteria

    1 forms  
    1. StudyEvent: ODM
      1. Elimination Criteria
    Note
    Description

    Note

    Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
    Description

    Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis

    Data type

    text

    Elimination Criteria
    Description

    Elimination Criteria

    Check all that apply
    Description

    Check all that apply

    Data type

    text

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    Elimination Criteria

    1 forms
    1. StudyEvent: ODM
      1. Elimination Criteria
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Note
    Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
    Item
    Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
    text
    Item Group
    Elimination Criteria
    Item
    Check all that apply
    text
    Check all that apply
    Code List
    Check all that apply
    CL Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period. (1)
    CL Item
    Newly diagnosed immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, during the study period (2)
    CL Item
    Administration of a licensed vaaccine not foreseen in the study protocol during the study (30 days prior to the first vaccicnation until study end(Week 12)). (3)
    CL Item
    Chronic administration (defined as more than 14 days) of immunosuppresants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (4)
    CL Item
    Administration of immunoglobulins and/or any blood products during the study period. (5)
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