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25108

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash/Exanthem, Parotid swelling and febrile convulsion 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

Keywords

Versions (1)
  1. 8/26/17 8/26/17 -
Copyright Holder

glaxoSmithKline

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August 26, 2017

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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

    English

    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

    1 forms  
    Rash / Exanthem
    Description

    Rash / Exanthem

    Alias
    UMLS CUI-1
    C0015230
    Has any rash/exanthem event occurred during 42 days post-vaccination ?
    Description

    Do not report here Varicella or Zoster but report in the Varicella or Zoster Case section. If yes, please complete the following table.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0042196
    Rash / Exanthem
    Description

    Rash / Exanthem

    Alias
    UMLS CUI-1
    C0015230
    Rash No.
    Description

    Rash number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0449788
    Description
    Description

    Description of rash

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0678257
    Description (Localisation)
    Description

    Localisation of rash

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1515974
    Localisation of rash
    Description

    Only answer if you chose "localized".

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0475264
    Please specify 'other location'.
    Description

    Other location specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1515974
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Category
    Description

    Category of rash

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0683312
    Please specify 'other category'.
    Description

    specify other category

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0683312
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Date started
    Description

    Start Date of rash

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Description

    End Date of rash

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0806020
    Intensity
    Description

    Intensity of rash

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0518690
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Relationship to investigational products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015230
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0042210
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547647
    Medically attended visit?
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    If yes please specify type of visit.
    Description

    Specify type of visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0281907
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1521902
    Parotid / Salivary gland swelling events
    Description

    Parotid / Salivary gland swelling events

    Alias
    UMLS CUI-1
    C0240925
    UMLS CUI-3
    C0240668
    Has any parotid / salivary gland swelling event occurred during 42 days post-vaccination ?
    Description

    If yes, please complete the following table.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0240925
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [2,1]
    C0240668
    UMLS CUI [2,2]
    C0042196
    Parotid / Salivary gland swelling events
    Description

    Parotid / Salivary gland swelling events

    Alias
    UMLS CUI-1
    C0240925
    UMLS CUI-2
    C0240668
    Parotid swelling No.
    Description

    Parotid Swelling number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0449788
    Description
    Description

    Description of parotid swelling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0678257
    Date started
    Description

    Start date of parotid swelling

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Description

    End date of parotid swelling

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0806020
    Intensity
    Description

    Intensity of parotid swelling

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0518690
    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
    Description

    Saliva sample

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0438730
    Date saliva sample was taken
    Description

    Only answer if you choose 'yes' in previous question.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0438730
    UMLS CUI [1,2]
    C0011008
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Relationship to investigational products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0240668
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0042210
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547647
    Medically attended visit?
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    If yes, please specify type of visit.
    Description

    Specify type of visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0281907
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1521902
    Febrile convulsions - Suspected signs of meningism events
    Description

    Febrile convulsions - Suspected signs of meningism events

    Alias
    UMLS CUI-1
    C0009952
    UMLS CUI-3
    C0025287
    Have any febrile convulsion or any suspected signs of meningism occurred during 42 days post-vaccination ?
    Description

    Febrile convulsions - Suspected signs of meningism events

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [2,1]
    C0025287
    UMLS CUI [2,2]
    C0042196
    Febrile convulsions - Suspected signs of meningism events
    Description

    Febrile convulsions - Suspected signs of meningism events

    Alias
    UMLS CUI-1
    C0009952
    UMLS CUI-2
    C0025287
    Febrile Convulsion No.
    Description

    Febrile convulsion number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0449788
    Description
    Description

    Description of febrile convulsion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0678257
    Date started
    Description

    Start date of febrile convulsion

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0808070
    Date stopped
    Description

    End date of febrile convulsion

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0806020
    Intensity
    Description

    Intensity of febrile convulsion

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0518690
    Was a neurological examination performed?
    Description

    Neurological examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027853
    If yes, was a lumbar puncture performed?
    Description

    Only answer if you answered previous question with 'yes'.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0553794
    Date of exam
    Description

    Only answer if neurological examination was performed.

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0027853
    UMLS CUI [1,2]
    C0011008
    If yes, was a sample sent to GSK BIO?
    Description

    spinal fluid sample

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1973491
    UMLS CUI [1,2]
    C0420724
    Level of diagnostic certainty
    Description

    Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0332146
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    Description

    Relationship to investigational products

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009952
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C0042210
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1547647
    Medically attended visit?
    Description

    Medically attended visit

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [1,3]
    C1518404
    If yes please specify type of visit.
    Description

    Specify type of visit

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0281907
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1521902
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    GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Rash, Parotid swelling, Febrile convulsion

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Rash / Exanthem
    C0015230 (UMLS CUI-1)
    rash post-vaccination
    Item
    Has any rash/exanthem event occurred during 42 days post-vaccination ?
    boolean
    C0015230 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    Item Group
    Rash / Exanthem
    C0015230 (UMLS CUI-1)
    Rash number
    Item
    Rash No.
    integer
    C0015230 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Description of rash
    Item
    Description
    text
    C0015230 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Item
    Description (Localisation)
    integer
    C0678257 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    Localisation of rash
    Code List
    Description (Localisation)
    CL Item
    Generalized (1)
    CL Item
    Localized (2)
    Item
    Localisation of rash
    integer
    C0015230 (UMLS CUI [1,1])
    C0475264 (UMLS CUI [1,2])
    Localisation rash
    Code List
    Localisation of rash
    CL Item
    Administration site (1)
    CL Item
    Other location : specify (2)
    Other location specify
    Item
    Please specify 'other location'.
    text
    C1515974 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Item
    Category
    integer
    C0015230 (UMLS CUI [1,1])
    C0683312 (UMLS CUI [1,2])
    Category of rash
    Code List
    Category
    CL Item
    Measles / rubella-rash (1)
    CL Item
    Other (2)
    specify other category
    Item
    Please specify 'other category'.
    text
    C0683312 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Start Date of rash
    Item
    Date started
    date
    C0015230 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End Date of rash
    Item
    Date stopped
    date
    C0015230 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0015230 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of rash
    Code List
    Intensity
    CL Item
    1-50 lesions (1)
    CL Item
    51-100 lesions (2)
    CL Item
    101-500 lesions (3)
    CL Item
    >500 lesions (4)
    Relationship to investigational products
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0015230 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item
    Outcome
    integer
    C1547647 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered / resolved (1)
    CL Item
    Recovering / resolving (2)
    CL Item
    Not recovered / not resolved (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
    Medically attended visit
    Item
    Medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item
    If yes please specify type of visit.
    text
    C0281907 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Specify type of visit
    Code List
    If yes please specify type of visit.
    CL Item
    Hospitalisation  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Item Group
    Parotid / Salivary gland swelling events
    C0240925 (UMLS CUI-1)
    C0240668 (UMLS CUI-3)
    Parotid / Salivary gland swelling events
    Item
    Has any parotid / salivary gland swelling event occurred during 42 days post-vaccination ?
    boolean
    C0240925 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0240668 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    Item Group
    Parotid / Salivary gland swelling events
    C0240925 (UMLS CUI-1)
    C0240668 (UMLS CUI-2)
    Parotid Swelling number
    Item
    Parotid swelling No.
    integer
    C0240668 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Description of parotid swelling
    Item
    Description
    text
    C0240668 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Start date of parotid swelling
    Item
    Date started
    date
    C0240668 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date of parotid swelling
    Item
    Date stopped
    text
    C0240668 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    integer
    C0240668 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of parotid swelling
    Code List
    Intensity
    CL Item
    Swelling without difficulties to move the jaw. (1)
    CL Item
    Swelling with difficulties to move the jaw. (2)
    CL Item
    Swelling and additional general symptoms. (3)
    Saliva sample
    Item
    Has a saliva sample been taken for mumps virus detection, strain identification and for viral culture?
    boolean
    C0438730 (UMLS CUI [1])
    Date of saliva sample
    Item
    Date saliva sample was taken
    date
    C0438730 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Relationship to investigational products
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0240668 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item
    Outcome
    integer
    C1547647 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered / resolved  (1)
    CL Item
    Recovering / resolving  (2)
    CL Item
    Not recovered / not resolved  (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
    Medically attended visit
    Item
    Medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item
    If yes, please specify type of visit.
    text
    C0281907 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Specify type of visit
    Code List
    If yes, please specify type of visit.
    CL Item
    Hospitalisation  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
    Item Group
    Febrile convulsions - Suspected signs of meningism events
    C0009952 (UMLS CUI-1)
    C0025287 (UMLS CUI-3)
    Febrile convulsions - Suspected signs of meningism events
    Item
    Have any febrile convulsion or any suspected signs of meningism occurred during 42 days post-vaccination ?
    boolean
    C0009952 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0025287 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    Item Group
    Febrile convulsions - Suspected signs of meningism events
    C0009952 (UMLS CUI-1)
    C0025287 (UMLS CUI-2)
    Febrile convulsion number
    Item
    Febrile Convulsion No.
    integer
    C0009952 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    Description of febrile convulsion
    Item
    Description
    text
    C0009952 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    Start date of febrile convulsion
    Item
    Date started
    date
    C0009952 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    End date of febrile convulsion
    Item
    Date stopped
    date
    C0009952 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item
    Intensity
    text
    C0009952 (UMLS CUI [1,1])
    C0518690 (UMLS CUI [1,2])
    Intensity of febrile convulsion
    Code List
    Intensity
    CL Item
    mild (1)
    CL Item
    moderate (2)
    CL Item
    severe (3)
    Neurological examination
    Item
    Was a neurological examination performed?
    boolean
    C0027853 (UMLS CUI [1])
    lumbar puncture
    Item
    If yes, was a lumbar puncture performed?
    boolean
    C0553794 (UMLS CUI [1])
    Date of neurological examination
    Item
    Date of exam
    date
    C0027853 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    spinal fluid sample
    Item
    If yes, was a sample sent to GSK BIO?
    boolean
    C1973491 (UMLS CUI [1,1])
    C0420724 (UMLS CUI [1,2])
    Item
    Level of diagnostic certainty
    integer
    C0009952 (UMLS CUI [1,1])
    C0332146 (UMLS CUI [1,2])
    Diagnostic certainty
    Code List
    Level of diagnostic certainty
    CL Item
    Level 1 (1)
    CL Item
    Level 2 (2)
    CL Item
    Level 3 (3)
    CL Item
    Level 4 (4)
    CL Item
    Level 5 (5)
    Relationship to investigational products
    Item
    Is there a reasonable possibility that the AE may have been caused by the investigational product?
    boolean
    C0009952 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item
    Outcome
    integer
    C1547647 (UMLS CUI [1])
    Outcome
    Code List
    Outcome
    CL Item
    Recovered / resolved  (1)
    CL Item
    Recovering / resolving  (2)
    CL Item
    Not recovered / not resolved  (3)
    CL Item
    Recovered with sequelae / resolved with sequelae (4)
    Medically attended visit
    Item
    Medically attended visit?
    boolean
    C0545082 (UMLS CUI [1,1])
    C1386497 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item
    If yes please specify type of visit.
    text
    C0281907 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Specify type of visit
    Code List
    If yes please specify type of visit.
    CL Item
    Hospitalisation  (HO)
    CL Item
    Emergency Room  (ER)
    CL Item
    Medical Personnel (MD)
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