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ID

32988

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 CRF Seiten: 268-336; 870-938

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Versions (2)
  1. 11/22/18 11/22/18 -
  2. 11/26/18 11/26/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 22, 2018

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License

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

    English

    Medical History

    1 forms  
    1. StudyEvent: ODM
      1. Medical History
    Administrative data
    Description

    Administrative data

    Visit Number
    Description

    Visit Number

    Data type

    text

    Date of Visit
    Description

    Date of Visit

    Data type

    date

    Subject Number
    Description

    Subject Number

    Data type

    integer

    General Medical History / Physical Examination
    Description

    General Medical History / Physical Examination

    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    Description

    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?

    Data type

    text

    Cutaneous
    Description

    Cutaneous

    Data type

    text

    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Eyes
    Description

    Eyes

    Data type

    text

    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Ears-Nose-Throat
    Description

    Ears-Nose-Throat

    Data type

    text

    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Cardiovascular
    Description

    Cardiovascular

    Data type

    text

    Diagnosis
    Description

    Diagnosis

    Data type

    text

    Respiratory
    Description

    Respiratory

    Data type

    text

    Gastrointestinal
    Description

    Gastrointestinal

    Data type

    text

    Muskuloskeletal
    Description

    Muskuloskeletal

    Data type

    text

    Neurological
    Description

    Neurological

    Data type

    text

    Genitourinary
    Description

    Genitourinary

    Data type

    text

    Haematology
    Description

    Haematology

    Data type

    text

    Allergies
    Description

    Allergies

    Data type

    text

    Endocrine
    Description

    Endocrine

    Data type

    text

    Other, specify
    Description

    Other, specify

    Data type

    text

    Concomitant Medications
    Description

    Concomitant Medications

    Please report medication(s) as specified in the protocol and fill in the Medication section
    Description

    Please report medication(s) as specified in the protocol and fill in the Medication section

    Data type

    text

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    Similar models

    Medical History

    1 forms
    1. StudyEvent: ODM
      1. Medical History
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Item
    Visit Number
    text
    Visit Number
    Code List
    Visit Number
    CL Item
    Visit 1 (1)
    Date of Visit
    Item
    Date of Visit
    date
    Subject Number
    Item
    Subject Number
    integer
    Item Group
    General Medical History / Physical Examination
    Item
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    text
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    Code List
    Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
    CL Item
    No (1)
    CL Item
    Yes -> please tick appropriate box(es) and give diagnosis (2)
    Item
    Cutaneous
    text
    Cutaneous
    Code List
    Cutaneous
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Eyes
    text
    Eyes
    Code List
    Eyes
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Ears-Nose-Throat
    text
    Ears-Nose-Throat
    Code List
    Ears-Nose-Throat
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Cardiovascular
    text
    Cardiovascular
    Code List
    Cardiovascular
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Respiratory
    text
    Respiratory
    Code List
    Respiratory
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Gastrointestinal
    text
    Gastrointestinal
    Code List
    Gastrointestinal
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Muskuloskeletal
    text
    Muskuloskeletal
    Code List
    Muskuloskeletal
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Neurological
    text
    Neurological
    Code List
    Neurological
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Genitourinary
    text
    Genitourinary
    Code List
    Genitourinary
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Haematology
    text
    Haematology
    Code List
    Haematology
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Allergies
    text
    Allergies
    Code List
    Allergies
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Endocrine
    text
    Endocrine
    Code List
    Endocrine
    CL Item
    Current (1)
    CL Item
    Past (2)
    Other, specify
    Item
    Other, specify
    text
    Item Group
    Concomitant Medications
    Please report medication(s) as specified in the protocol and fill in the Medication section
    Item
    Please report medication(s) as specified in the protocol and fill in the Medication section
    text
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