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23655

Descrizione

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: Study to assess immunogenicity and non-inferiority of investigational vaccination regimen as compared to Tritanrix-HepB/Hiberix and as compared to Meningitec when administered to healthy infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Documentation part: Non-Serious Adverse Events

Keywords

versioni (2)
  1. 10/07/17 10/07/17 -
  2. 04/05/18 04/05/18 - Sarah Riepenhausen
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10 luglio 2017

DOI

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Creative Commons BY-NC 3.0
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    Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec Non-Serious Adverse Events 100480

    Inglese

    Non-Serious Adverse Events Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

    1 moduli  
    Non-serious Adverse Events
    Descrizione

    Non-serious Adverse Events

    Alias
    UMLS CUI-1
    C1518404 (Non-serious Adverse Event)
    UMLS CUI-2
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    Subject Number
    Descrizione

    Subject Number

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
    Descrizione

    If YES, please complete the following table.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C1518404 (Non-serious Adverse Event)
    Adverse Event Number
    Descrizione

    Adverse Event Number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    Non-serious adverse events: Description
    Descrizione

    Description

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0678257 (Description)
    LOINC
    LP6800-9
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Non-serious adverse events: Description
    Descrizione

    Description

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0678257 (Description)
    LOINC
    LP6800-9
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Type of vaccine
    Descrizione

    Description of Non-Serious Adverse Event

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    UMLS CUI [2,1]
    C1518404 (Non-serious Adverse Event)
    UMLS CUI [2,2]
    C0678257 (Description)
    LOINC
    LP6800-9
    Start Date
    Descrizione

    Start Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Start: during immediate post-vaccination period (30 minutes)
    Descrizione

    Start

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0439659 (Beginning)
    SNOMED
    255395001
    LOINC
    LP21371-7
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    End Date
    Descrizione

    End Date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Maximum Intensity
    Descrizione

    Maximum Intensity

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C1710056 (Seriousness of Adverse Event)
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
    Descrizione

    Relationship to investigational product(s)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0085978 (Causations)
    UMLS CUI [1,3]
    C1518404 (Non-serious Adverse Event)
    Outcome
    Descrizione

    Outcome

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1705586 (Adverse Event Outcome)
    UMLS CUI [1,2]
    C1518404 (Non-serious Adverse Event)
    Medically attended visit?
    Descrizione

    Medically attended visit

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C1386497 (advice; medical)
    UMLS CUI [2]
    C1518404 (Non-serious Adverse Event)
    Medically attended visit type
    Descrizione

    Did the subject seek medical advice? If yes, please specify type

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    UMLS CUI [1,3]
    C1386497 (advice; medical)
    UMLS CUI [2]
    C1518404 (Non-serious Adverse Event)
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    Similar models

    Non-Serious Adverse Events Investigational vaccination compared to Tritanrix-HepB/Hiberix and Meningitec 100480

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    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 (minimum 30 days) 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 (minimum 30 days) 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)
    Item
    Type of vaccine
    integer
    C0042210 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [2,1])
    C0678257 (UMLS CUI [2,2])
    undefined item
    Code List
    Type of vaccine
    CL Item
    Tritanrix-HepB/Hib-MenAC vaccine (1)
    CL Item
    Tritanrix-HepB/Hiberix vaccine (2)
    CL Item
    Meningitec vaccine (3)
    Start Date
    Item
    Start Date
    date
    C0808070 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    Start
    Item
    Start: during immediate post-vaccination period (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)
    Relationship to investigational product(s)
    Item
    Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0085978 (UMLS CUI [1,2])
    C1518404 (UMLS CUI [1,3])
    Item
    Outcome
    text
    C1705586 (UMLS CUI [1,1])
    C1518404 (UMLS CUI [1,2])
    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 [2])
    Item
    Medically attended visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C1386497 (UMLS CUI [1,3])
    C1518404 (UMLS CUI [2])
    Medical advice type
    Code List
    Medically attended visit type
    CL Item
    Hospitalisation (HO)
    CL Item
    Emergency room (ER)
    CL Item
    Medical doctor (MD)
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