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ID

24480

Description

Study ID: 100580 Clinical Study ID: 100580 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 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 Documentation part: Additional Vaccination - Concomitant Vaccinations, Medication, Non Serious Adverse Events

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Keywords

Versions (1)
  1. 8/2/17 8/2/17 -
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August 2, 2017

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Creative Commons BY-NC 3.0
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    Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Additional Vaccination 100580

    English

    Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 1005780

    1 forms  
    Concomitant Vaccination
    Description

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
    Description

    vaccine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042210
    Trade/Generic Name
    Description

    Name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C0042210
    Administration date
    Description

    Administration date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    Medication
    Description

    Medication

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0087111
    Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
    Description

    Medication

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0013227
    UMLS CUI [2]
    C0087111
    Trade or generic name
    Description

    Medication name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    Medical Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C3146298
    UMLS CUI [1,2]
    C0013227
    Medical Indication: Prophylactic?
    Description

    Prophylactic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0199176
    UMLS CUI [2,1]
    C3146298
    UMLS CUI [2,2]
    C0013227
    Total daily dose
    Description

    Total daily dose

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C2348070
    UMLS CUI [1,2]
    C0013227
    Route
    Description

    Administration Route

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0013227
    Start Date
    Description

    Medication Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0808070
    End Date
    Description

    Medication End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0806020
    Medication Ongoing: tick box if continuing at end of Visit 22
    Description

    Medication Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
    Non-serious Adverse Events
    Description

    Non-serious Adverse Events

    Alias
    UMLS CUI-1
    C1518404
    UMLS CUI-2
    C0042210
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    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?
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1518404
    Adverse Event Number
    Description

    Adverse Event Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Non-serious adverse events: Description
    Description

    Description

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1518404
    Non-serious adverse events: Description
    Description

    Description

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1518404
    Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1518404
    Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
    Description

    Start

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0439659
    UMLS CUI [1,2]
    C1518404
    End Date
    Description

    End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0806020
    UMLS CUI [1,2]
    C1518404
    Maximum Intensity
    Description

    Maximum Intensity

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1710056
    UMLS CUI [1,2]
    C1518404
    In your opinion, did the vaccine possibly contribute to this AE?
    Description

    Causality

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229C0042210
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1518404
    Outcome
    Description

    Outcome

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1518404
    Back to the top of the page

    Similar models

    Additional Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 1005780

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    vaccine
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the protocol?
    boolean
    C0042210 (UMLS CUI [1])
    Name
    Item
    Trade/Generic Name
    text
    C0027365 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    Item Group
    Medication
    C0013227 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Item
    Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
    integer
    C0013227 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
    Medication
    Code List
    Have any of the above mentioned medications/treatments been administered from 30 days pre-vaccination to 30 days after additional vaccination?
    CL Item
    No (1)
    CL Item
    Yes, please complete the following table. (2)
    Medication name
    Item
    Trade or generic name
    text
    C2360065 (UMLS CUI [1])
    Indication
    Item
    Medical Indication
    text
    C3146298 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Prophylactic
    Item
    Medical Indication: Prophylactic?
    boolean
    C0199176 (UMLS CUI [1])
    C3146298 (UMLS CUI [2,1])
    C0013227 (UMLS CUI [2,2])
    Total daily dose
    Item
    Total daily dose
    text
    C2348070 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    Administration Route
    Code List
    Route
    CL Item
    External (EXT)
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intraarticular (IR)
    CL Item
    Intrathecal (IT)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Rectal (PR)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Topical (TO)
    CL Item
    Unknown (UNK)
    CL Item
    Vaginal (VA)
    Medication Start Date
    Item
    Start Date
    date
    C0013227 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Medication End Date
    Item
    End Date
    date
    C0013227 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Medication Ongoing
    Item
    Medication Ongoing: tick box if continuing at end of Visit 22
    boolean
    C2826666 (UMLS CUI [1])
    Item Group
    Non-serious Adverse Events
    C1518404 (UMLS CUI-1)
    C0042210 (UMLS CUI-2)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    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?
    integer
    C1518404 (UMLS CUI [1])
    Withdrawal
    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 (1)
    CL Item
    Yes, please complete the following table (2)
    Adverse Event Number
    Item
    Adverse Event Number
    integer
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Description
    Item
    Non-serious adverse events: Description
    text
    C0678257 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item
    Non-serious adverse events: Description
    integer
    C0678257 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Description
    Code List
    Non-serious adverse events: Description
    CL Item
    Administration sites (1)
    CL Item
    Non-administration site (2)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Start
    Item
    Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
    boolean
    C0439659 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    End Date
    Item
    End Date
    date
    C0806020 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Item
    Maximum Intensity
    integer
    C1710056 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Withdrawal
    Code List
    Maximum Intensity
    CL Item
    Mild (1)
    CL Item
    Modearte (2)
    CL Item
    Severe (3)
    Causality
    Item
    In your opinion, did the vaccine possibly contribute to this AE?
    boolean
    C0304229C0042210 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item
    Outcome
    integer
    C1705586 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Outcome
    Code List
    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)
    Back to the top of the page 

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