0 Evaluaciones

ID

32988

Descripción

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

Palabras clave

  1. 22/11/18 22/11/18 -
  2. 26/11/18 26/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

22 de noviembre de 2018

DOI

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Licencia

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

    Medical History

    1. StudyEvent: ODM
      1. Medical History
    Administrative data
    Descripción

    Administrative data

    Visit Number
    Descripción

    Visit Number

    Tipo de datos

    text

    Date of Visit
    Descripción

    Date of Visit

    Tipo de datos

    date

    Subject Number
    Descripción

    Subject Number

    Tipo de datos

    integer

    General Medical History / Physical Examination
    Descripción

    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?
    Descripción

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

    Tipo de datos

    text

    Cutaneous
    Descripción

    Cutaneous

    Tipo de datos

    text

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    text

    Eyes
    Descripción

    Eyes

    Tipo de datos

    text

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    text

    Ears-Nose-Throat
    Descripción

    Ears-Nose-Throat

    Tipo de datos

    text

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    text

    Cardiovascular
    Descripción

    Cardiovascular

    Tipo de datos

    text

    Diagnosis
    Descripción

    Diagnosis

    Tipo de datos

    text

    Respiratory
    Descripción

    Respiratory

    Tipo de datos

    text

    Gastrointestinal
    Descripción

    Gastrointestinal

    Tipo de datos

    text

    Muskuloskeletal
    Descripción

    Muskuloskeletal

    Tipo de datos

    text

    Neurological
    Descripción

    Neurological

    Tipo de datos

    text

    Genitourinary
    Descripción

    Genitourinary

    Tipo de datos

    text

    Haematology
    Descripción

    Haematology

    Tipo de datos

    text

    Allergies
    Descripción

    Allergies

    Tipo de datos

    text

    Endocrine
    Descripción

    Endocrine

    Tipo de datos

    text

    Other, specify
    Descripción

    Other, specify

    Tipo de datos

    text

    Concomitant Medications
    Descripción

    Concomitant Medications

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

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

    Tipo de datos

    text

    Similar models

    Medical History

    1. StudyEvent: ODM
      1. Medical History
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    Item
    Visit Number
    text
    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
    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
    Code List
    Cutaneous
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Eyes
    text
    Code List
    Eyes
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Ears-Nose-Throat
    text
    Code List
    Ears-Nose-Throat
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Cardiovascular
    text
    Code List
    Cardiovascular
    CL Item
    Current (1)
    CL Item
    Past (2)
    Diagnosis
    Item
    Diagnosis
    text
    Item
    Respiratory
    text
    Code List
    Respiratory
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Gastrointestinal
    text
    Code List
    Gastrointestinal
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Muskuloskeletal
    text
    Code List
    Muskuloskeletal
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Neurological
    text
    Code List
    Neurological
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Genitourinary
    text
    Code List
    Genitourinary
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Haematology
    text
    Code List
    Haematology
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Allergies
    text
    Code List
    Allergies
    CL Item
    Current (1)
    CL Item
    Past (2)
    Item
    Endocrine
    text
    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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