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25393

Description

Phase A - Year 2 Extension - Telephone contact 27 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

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  1. 9/2/17 9/2/17 -
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glaxoSmithKline

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September 2, 2017

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    Phase A - Year 2 Extension - Telephone contact 27 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    English

    Phase A - Year 2 Extension - Telephone contact 27 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms  
    Subject's contact
    Description

    Subject's contact

    Alias
    UMLS CUI-1
    C0332158 (Contact with)
    SNOMED
    11723008
    UMLS CUI-2
    C0681850 (Study Subject)
    Was the subject successfully contacted at scheduled Telephone Contact 27?
    Description

    telephone contact

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0420309 (Planned telephone contact)
    SNOMED
    183631005
    Has the subject been seen or contacted between the previous contact and this contact?
    Description

    Only fill in, if you answered previous question with 'no'.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332158 (Contact with)
    SNOMED
    11723008
    UMLS CUI [1,2]
    C0681850 (Study Subject)
    Last date
    Description

    Date of last contact

    Data type

    date

    Alias
    UMLS CUI [1]
    C0805839 (Date last contact)
    LOINC
    MTHU010432
    Household exposure
    Description

    Household exposure

    Alias
    UMLS CUI-1
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI-2
    C0020052 (Households)
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between the previous contact and this contact?
    Description

    Exposure in household to varicella/zoster

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    UMLS CUI [1,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [1,3]
    C0020052 (Households)
    UMLS CUI [2,1]
    C0740380 (Varicella zoster)
    UMLS CUI [2,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [2,3]
    C0020052 (Households)
    Household exposure number
    Description

    Household exposure number

    Alias
    UMLS CUI-1
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI-2
    C0020052 (Households)
    UMLS CUI-3
    C0449788 (Count of entities)
    SNOMED
    410681005
    Household Exposure No
    Description

    Household Exposure No

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332157 (Exposure to)
    SNOMED
    24932003
    UMLS CUI [1,2]
    C0020052 (Households)
    UMLS CUI [1,3]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Date of onset exposure
    Description

    Date of onset exposure

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0574845 (Date of onset)
    SNOMED
    298059007
    LOINC
    MTHU048807
    UMLS CUI [1,2]
    C0332157 (Exposure to)
    SNOMED
    24932003
    Type of exposure
    Description

    Type of exposure

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0332157 (Exposure to)
    SNOMED
    24932003
    Varicella or zoster
    Description

    Varicella or zoster

    Alias
    UMLS CUI-1
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    UMLS CUI-3
    C0740380 (Varicella zoster)
    Did the subject present any signs of varicella or zoster symptoms between the previous contact and this contact?
    Description

    if 'yes', please complete the Varicella or Zoster Case section.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [1,2]
    C0740380 (Varicella zoster)
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    How many episodes?
    Description

    Number of episodes of varicella/zoster signs and symptoms

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [1,2]
    C0740380 (Varicella zoster)
    UMLS CUI [2,1]
    C0037088 (Signs and Symptoms)
    SNOMED
    404684003
    LOINC
    LP185402-7
    UMLS CUI [2,2]
    C0008049 (Chickenpox)
    SNOMED
    38907003
    LOINC
    LA10517-3
    Serious adverse event
    Description

    Serious adverse event

    Alias
    UMLS CUI-1
    C1519255 (Serious Adverse Event)
    Did the subject experience any serious adverse event between the previous contact and this contact?
    Description

    If 'yes, please complete the Serious Adverse Event form.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1519255 (Serious Adverse Event)
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    Similar models

    Phase A - Year 2 Extension - Telephone contact 27 - GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Subject's contact
    C0332158 (UMLS CUI-1)
    C0681850 (UMLS CUI-2)
    Item
    Was the subject successfully contacted at scheduled Telephone Contact 27?
    integer
    C0420309 (UMLS CUI [1])
    telephone contact
    Code List
    Was the subject successfully contacted at scheduled Telephone Contact 27?
    CL Item
    Yes (1)
    CL Item
    No (2)
    CL Item
    NA: Not applicable, please complete if there is no need to perform this telephone contact due to the end of Phase A. (3)
    contact with subject
    Item
    Has the subject been seen or contacted between the previous contact and this contact?
    boolean
    C0332158 (UMLS CUI [1,1])
    C0681850 (UMLS CUI [1,2])
    Date of last contact
    Item
    Last date
    date
    C0805839 (UMLS CUI [1])
    Item Group
    Household exposure
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    Exposure in household to varicella/zoster
    Item
    Irrespective of whether the subject developed/develops varicella/zoster, was the subject exposed for more than one day to any varicella or zoster case presented by a household member or another person living temporarily within the household between the previous contact and this contact?
    boolean
    C0008049 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    C0020052 (UMLS CUI [1,3])
    C0740380 (UMLS CUI [2,1])
    C0332157 (UMLS CUI [2,2])
    C0020052 (UMLS CUI [2,3])
    Item Group
    Household exposure number
    C0332157 (UMLS CUI-1)
    C0020052 (UMLS CUI-2)
    C0449788 (UMLS CUI-3)
    Household Exposure No
    Item
    Household Exposure No
    integer
    C0332157 (UMLS CUI [1,1])
    C0020052 (UMLS CUI [1,2])
    C0449788 (UMLS CUI [1,3])
    Date of onset exposure
    Item
    Date of onset exposure
    date
    C0574845 (UMLS CUI [1,1])
    C0332157 (UMLS CUI [1,2])
    Item
    Type of exposure
    integer
    C0332157 (UMLS CUI [1])
    Type of exposure
    Code List
    Type of exposure
    CL Item
    Varicella (1)
    CL Item
    Zoster (2)
    Item Group
    Varicella or zoster
    C0008049 (UMLS CUI-1)
    C0740380 (UMLS CUI-3)
    signs or symptoms of varicella or zoster
    Item
    Did the subject present any signs of varicella or zoster symptoms between the previous contact and this contact?
    boolean
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    Number of episodes of varicella/zoster signs and symptoms
    Item
    How many episodes?
    integer
    C0037088 (UMLS CUI [1,1])
    C0740380 (UMLS CUI [1,2])
    C0037088 (UMLS CUI [2,1])
    C0008049 (UMLS CUI [2,2])
    Item Group
    Serious adverse event
    C1519255 (UMLS CUI-1)
    serious adverse event
    Item
    Did the subject experience any serious adverse event between the previous contact and this contact?
    boolean
    C1519255 (UMLS CUI [1])
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