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ID

25902

Beschrijving

Study ID: 100571 (M138) Clinical Study ID: 100571 Study Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 12 month schedule in healthy adult volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A https://clinicaltrials.gov/ct2/show/NCT00291876

Link

https://clinicaltrials.gov/ct2/show/NCT00291876

Trefwoorden

Versies (2)
  1. 23-08-17 23-08-17 -
  2. 26-09-17 26-09-17 -
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26 september 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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    GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS NCT00291876

    Engels

    GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS NCT00291876

    1 Formulieren  
    Study administration
    Beschrijving

    Study administration

    Center
    Beschrijving

    Center

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Date of Visit
    Beschrijving

    Date of Visit

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Number
    Beschrijving

    Subject Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    NON-SERIOUS ADVERSE EVENTS
    Beschrijving

    NON-SERIOUS ADVERSE EVENTS

    Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
    Beschrijving

    (Please report all serious adverse events only on the Serious Adverse Event (SAE) form).

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1518404
    NON-SERIOUS ADVERSE EVENTS
    Beschrijving

    NON-SERIOUS ADVERSE EVENTS

    AE No.
    Beschrijving

    adverse event number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0449788
    Description
    Beschrijving

    adverse event description

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0678257
    For GSK
    Beschrijving

    comment

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611
    Local (administration site)
    Beschrijving

    adverse event location

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0450429
    UMLS CUI [1,3]
    C0205276
    Non-administration site
    Beschrijving

    adverse event location2

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0450429
    Date started
    Beschrijving

    adverse event start date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2697888
    during immediate postvaccination period specified in protocol
    Beschrijving

    immediate post-vaccination reaction

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2697888
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C0042196
    Date Stopped
    Beschrijving

    adverse event end date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2697886
    Intensity
    Beschrijving

    adverse event intensity

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C1710066
    Causality In your opinion, did the vaccine possibly contribute to this AE?
    Beschrijving

    causality

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3641099
    UMLS CUI [1,2]
    C0877248
    Adverse Event Outcome
    Beschrijving

    Adverse Event Outcome

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1705586
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    Similar models

    GSK Hepatitis A Vaccine ADDITIONAL VACCINATION NON SERIOUS ADVERSE EVENTS NCT00291876

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Study administration
    Center
    Item
    Center
    text
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Date of Visit
    Item
    Date of Visit
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    NON-SERIOUS ADVERSE EVENTS
    Item
    Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
    text
    C1518404 (UMLS CUI [1])
    non serious adverse event
    Code List
    Has any non-serious adverse events occurred within one month (Day 0 to Day 29) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
    CL Item
    No (No)
    CL Item
    Yes, please complete the following table. (Yes, please complete the following table.)
    Item Group
    NON-SERIOUS ADVERSE EVENTS
    adverse event number
    Item
    AE No.
    integer
    C0877248 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    adverse event description
    Item
    Description
    text
    C0877248 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    comment
    Item
    For GSK
    text
    C0947611 (UMLS CUI [1])
    adverse event location
    Item
    Local (administration site)
    boolean
    C0877248 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    C0205276 (UMLS CUI [1,3])
    adverse event location2
    Item
    Non-administration site
    boolean
    C0877248 (UMLS CUI [1,1])
    C0450429 (UMLS CUI [1,2])
    adverse event start date
    Item
    Date started
    date
    C2697888 (UMLS CUI [1])
    immediate post-vaccination reaction
    Item
    during immediate postvaccination period specified in protocol
    boolean
    C2697888 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C0042196 (UMLS CUI [1,3])
    adverse event end date
    Item
    Date Stopped
    date
    C2697886 (UMLS CUI [1])
    Item
    Intensity
    integer
    C1710066 (UMLS CUI [1])
    adverse event intensity
    Code List
    Intensity
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    causality
    Item
    Causality In your opinion, did the vaccine possibly contribute to this AE?
    boolean
    C3641099 (UMLS CUI [1,1])
    C0877248 (UMLS CUI [1,2])
    Item
    Adverse Event Outcome
    text
    C1705586 (UMLS CUI [1])
    Adverse Event Outcome
    Code List
    Adverse Event Outcome
    CL Item
    Recovered (1)
    CL Item
    Recovered with sequelae (2)
    CL Item
    Ongoing at subject study conclusion (3)
    CL Item
    Died (4)
    CL Item
    Unknown (5)
    CL Item
    fatal (6)
    Terug naar het begin van de pagina 

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