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ID

33074

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

Keywords

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 26, 2018

DOI

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License

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

    Eligibility Criteria

    1 forms  
    1. StudyEvent: ODM
      1. Eligibility Criteria
    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

    Eligibility Question
    Description

    Eligibility Question

    Did the subject meet all the entry criteria?
    Description

    Did the subject meet all the entry criteria?

    Data type

    boolean

    If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria
    Description

    Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below

    Data type

    text

    Inclusion Criteria
    Description

    Inclusion Criteria

    Tick the boxes corresponding to any of the inclusion criteria the subject failed
    Description

    Tick the boxes corresponding to any of the inclusion criteria the subject failed

    Data type

    text

    Exclusion Criteria
    Description

    Exclusion Criteria

    Record if any of the exclusion criteria disqualified the subject from entry
    Description

    tick Yes, if disqualified, tick No, if not disqualified

    Data type

    text

    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Description

    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    Data type

    boolean

    Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
    Description

    For corticosteroids this will mean prednisone, or equivalet, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed

    Data type

    boolean

    Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
    Description

    Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)

    Data type

    boolean

    Previous vaccination against measles, mumps, rubella and/or varicella
    Description

    Previous vaccination against measles, mumps, rubella and/or varicella

    Data type

    boolean

    History of measles, mumps, rubella and/or varicella/zoster diseases
    Description

    History of measles, mumps, rubella and/or varicella/zoster diseases

    Data type

    boolean

    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
    Description

    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial

    Data type

    boolean

    Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
    Description

    Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection

    Data type

    boolean

    A family history of congenital or hereditary immunodeficiency
    Description

    A family history of congenital or hereditary immunodeficiency

    Data type

    boolean

    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
    Description

    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine

    Data type

    boolean

    Major congenital defects or serious chronic illness
    Description

    Major congenital defects or serious chronic illness

    Data type

    boolean

    History of any neurologic disorders or seizures
    Description

    History of any neurologic disorders or seizures

    Data type

    boolean

    Residence in the same household as high-risk persons
    Description

    high-risk persons: new-born infants (0-4 weeks of age); pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox; persons with known immunodeficiency

    Data type

    boolean

    Acute disease at the time of enrolment
    Description

    The presence of a moderate or severe illness with or without fever. All vaccines cn be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., axillary temperature <37.5°C/ rectal temperature <38°C.

    Data type

    boolean

    Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
    Description

    Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination

    Data type

    boolean

    Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
    Description

    Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period

    Data type

    boolean

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    Similar models

    Eligibility Criteria

    1 forms
    1. StudyEvent: ODM
      1. Eligibility Criteria
    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
    Eligibility Question
    Did the subject meet all the entry criteria?
    Item
    Did the subject meet all the entry criteria?
    boolean
    If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria.
    Item
    If No, tick all boxes corresponding to violations of any exclusion/inclusion criteria
    text
    Item Group
    Inclusion Criteria
    Item
    Tick the boxes corresponding to any of the inclusion criteria the subject failed
    text
    Tick the boxes corresponding to any of the inclusion criteria the subject failed
    Code List
    Tick the boxes corresponding to any of the inclusion criteria the subject failed
    CL Item
    Subject who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study (1)
    CL Item
    Male or female subject between 11 and 21 months of age at the time of the first vaccination (2)
    CL Item
    Written informed consent obtained from the parent or guardian of the subject (3)
    CL Item
    Free of obvious health problems as established by medical history and clinical examination before entering into the study (4)
    Item Group
    Exclusion Criteria
    Record if any of the exclusion criteria disqualified the subject from entry
    Item
    Record if any of the exclusion criteria disqualified the subject from entry
    text
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    Item
    Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    boolean
    Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
    Item
    Chronic administration (more than 14 days) of immunodepressants or other immune-modifying drugs within six months prior to the first vaccine dose
    boolean
    Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
    Item
    Planned administration/administration of a vaccine not forseen by the study protocol from 30 days prior to the first vaccination until study end (Week 12)
    boolean
    Previous vaccination against measles, mumps, rubella and/or varicella
    Item
    Previous vaccination against measles, mumps, rubella and/or varicella
    boolean
    History of measles, mumps, rubella and/or varicella/zoster diseases
    Item
    History of measles, mumps, rubella and/or varicella/zoster diseases
    boolean
    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
    Item
    Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the present trial
    boolean
    Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
    Item
    Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection
    boolean
    A family history of congenital or hereditary immunodeficiency
    Item
    A family history of congenital or hereditary immunodeficiency
    boolean
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
    Item
    History of allergic disease or reactions likely to be exacerbated by any component of the vaccine
    boolean
    Major congenital defects or serious chronic illness
    Item
    Major congenital defects or serious chronic illness
    boolean
    History of any neurologic disorders or seizures
    Item
    History of any neurologic disorders or seizures
    boolean
    Residence in the same household as high-risk persons
    Item
    Residence in the same household as high-risk persons
    boolean
    Acute disease at the time of enrolment
    Item
    Acute disease at the time of enrolment
    boolean
    Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
    Item
    Rectal temperature >= 38°C or axillary temperature >=37.5°C at the time of vaccination
    boolean
    Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
    Item
    Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period
    boolean
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