ID

33073

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

Mots-clés

Versions (2)
  1. 22/11/2018 22/11/2018 -
  2. 26/11/2018 26/11/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

26 novembre 2018

DOI

Pour une demande vous connecter.

Licence

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

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    Medical History

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

    Administrative data

    Visit Number
    Description

    Visit Number

    Type de données

    text

    Date of Visit
    Description

    Date of Visit

    Type de données

    date

    Subject Number
    Description

    Subject Number

    Type de données

    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?

    Type de données

    text

    Cutaneous
    Description

    Cutaneous

    Type de données

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    Diagnosis
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    Eyes
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    Type de données

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    Diagnosis
    Description

    Diagnosis

    Type de données

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    Ears-Nose-Throat
    Description

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    Diagnosis
    Description

    Diagnosis

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    Cardiovascular
    Description

    Cardiovascular

    Type de données

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    Diagnosis
    Description

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    Type de données

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    Respiratory
    Description

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    Gastrointestinal
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    Genitourinary
    Description

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    Type de données

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    Haematology
    Description

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    Type de données

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    Allergies
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    text

    Endocrine
    Description

    Endocrine

    Type de données

    text

    Other, specify
    Description

    Other, specify

    Type de données

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    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

    Type de données

    text

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    Medical History

    1 Formulaires
    1. StudyEvent: ODM
      1. Medical History
    Name
    Type
    Description | Question | Decode (Coded Value)
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    Administrative data
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    General Medical History / Physical Examination
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    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?
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    Ears-Nose-Throat
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    Diagnosis
    Item
    Diagnosis
    text
    Item
    Cardiovascular
    text
    Cardiovascular
    Code List
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    Diagnosis
    Item
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    text
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    CL Item
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    CL Item
    Past (2)
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    Gastrointestinal
    text
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    text
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    text
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    Haematology
    text
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    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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