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ID

30023

Descrição

Study ID: 100480, 759346/004 & 100791 Clinical Study ID: 100480, 759346/004 & 100791 Study Title: A phase III, partially double blind, randomized, controlled primary vaccination study to assess the reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Tritanrix-HepB/Hib-MenAC vaccine as compared to Tritanrix-HepB/Hib2.5 + Meningitec™ when administered to healthy infants at 6, 10, 14 weeks of age, who have received a birth dose of hepatitis B vaccine. 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

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Versões (2)
  1. 10/07/2017 10/07/2017 -
  2. 04/05/2018 04/05/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

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4 de maio de 2018

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Creative Commons BY-NC 3.0
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    Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec Non-Serious Adverse Events 759346/004

    Inglês

    Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 Formulários  
    Non-serious Adverse Events
    Descrição

    Non-serious Adverse Events

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

    Subject Number

    Tipo de dados

    text

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

    If YES, please complete the following table.

    Tipo de dados

    integer

    Alias
    UMLS CUI [1]
    C1518404
    Adverse Event Number
    Descrição

    Adverse Event Number

    Tipo de dados

    integer

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

    Description

    Tipo de dados

    text

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

    Description

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0678257
    UMLS CUI [1,2]
    C1518404
    Type of vaccine
    Descrição

    Description of Non-Serious Adverse Event

    Tipo de dados

    integer

    Alias
    UMLS CUI [1,1]
    C0042210
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0678257
    Start Date
    Descrição

    Start Date

    Tipo de dados

    date

    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C1518404
    Start: during immediate post-vaccination period (30 minutes)
    Descrição

    Start

    Tipo de dados

    boolean

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

    End Date

    Tipo de dados

    date

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

    Maximum Intensity

    Tipo de dados

    integer

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

    Relationship to investigational product(s)

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0085978
    UMLS CUI [1,3]
    C1518404
    Outcome
    Descrição

    Outcome

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C1705586
    UMLS CUI [1,2]
    C1518404
    Medically attended visit?
    Descrição

    Medically attended visit

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C1386497
    UMLS CUI [2]
    C1518404
    Medically attended visit type
    Descrição

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

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C1386497
    UMLS CUI [2]
    C1518404
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    Similar models

    Non-Serious Adverse Events Tritanrix-HepB/Hib-MenAC vaccine compared to Tritanrix-HepB/Hiberix and Meningitec 759346/004

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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