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ID

23892

Descrizione

Study part: Vacccine Administration Booster Dose. A phase 2 study to assess safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen and GSK Biologicals Hib-MenC vaccine (co-administered with Infanrix penta) compared to a booster dose of Menjugate (co-administered with Infanrix hexa).Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Study ID: 100381, Clinical Study ID: 100381

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versioni (1)
  1. 16/07/17 16/07/17 -
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GlaxoSmithKline

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16 luglio 2017

DOI

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Creative Commons BY-NC 3.0
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    Vacccine Administration Booster Dose Hib-MenCY-TT-004 BST 003 Neisseria Meningitidis-Haemophilus influenzae type b Vaccine 100381

    Inglese

    Vacccine Administration Booster Dose

    1 moduli  
    Vaccine Administration Group Hib-MenCY or Hib-MenC
    Descrizione

    Vaccine Administration Group Hib-MenCY or Hib-MenC

    Alias
    UMLS CUI-1
    C2368628
    Subject number
    Descrizione

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Please complete only if different from visit date :
    Descrizione

    date vaccine administration

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Vaccine administration Hib-MenCY Vaccine
    Descrizione

    Side / site route: Left Thigh I.M.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2352428
    If Replacement vial, comment
    Descrizione

    comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Has the study vaccine been administered according to the Protocol ?
    Descrizione

    vaccine administration site route side

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0441987
    Vaccine administration DTPa-HBV-IPV Vaccine
    Descrizione

    Side / site route: Right Thigh I.M.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1121707
    If Replacement vial, comment
    Descrizione

    comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Has the study vaccine been administered according to the Protocol ?
    Descrizione

    vaccine administration site route side

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0441987
    Vaccine Administration Group Control
    Descrizione

    Vaccine Administration Group Control

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C0009932
    Subject number
    Descrizione

    Subject number

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Please complete only if different from visit date :
    Descrizione

    date vaccine administration

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Vaccine administration MenC Vaccine
    Descrizione

    Side / site route: Left Thigh I.M.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1720015
    If Replacement vial, comment
    Descrizione

    comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Has the study vaccine been administered according to the Protocol ?
    Descrizione

    vaccine administration site route side

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0441987
    Vaccine administration DTPa-HBV-IPV/Hib Vaccine
    Descrizione

    Side / site route: Right Thigh I.M.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1121707
    If Replacement vial, comment
    Descrizione

    comment

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0947611
    Has the study vaccine been administered according to the Protocol ?
    Descrizione

    vaccine administration site route side

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C1515974
    UMLS CUI [1,3]
    C0013153
    UMLS CUI [1,4]
    C0441987
    Why not administered ?
    Descrizione

    Why not administered ?

    Alias
    UMLS CUI-1
    C2368628
    UMLS CUI-2
    C0205544
    Why not administered ?
    Descrizione

    Vaccine administration cancelled

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C0205544
    If SAE, Please specify SAE N° :
    Descrizione

    SAE

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1519255
    If AEX, Please specify AE N° (Unsolicited) or code (Solicited) : :
    Descrizione

    non serious adverse event

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1518404
    If other, please specify
    Descrizione

    (e.g. : consent withdrawal, Protocol violation, …)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0205394
    Please tick who took the decision :
    Descrizione

    person Vaccine administration cancelled

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0027361
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    Similar models

    Vacccine Administration Booster Dose

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Vaccine Administration Group Hib-MenCY or Hib-MenC
    C2368628 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    date vaccine administration
    Item
    Please complete only if different from visit date :
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Item
    Vaccine administration Hib-MenCY Vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C2352428 (UMLS CUI [1,2])
    vaccine administration
    Code List
    Vaccine administration Hib-MenCY Vaccine
    CL Item
    Hib-MenCY Vaccine OR Hib-MenC Vaccine (Hib-MenCY Vaccine OR Hib-MenC Vaccine)
    CL Item
    Replacement vial (Replacement vial)
    CL Item
    Wrong vial number (Wrong vial number)
    CL Item
    Not administered (Not administered)
    comment
    Item
    If Replacement vial, comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Has the study vaccine been administered according to the Protocol ?
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [1,4])
    vaccine administration site route side
    Code List
    Has the study vaccine been administered according to the Protocol ?
    CL Item
    Yes (1)
    CL Item
    No, Side: Left, Site: Deltoid, Route: I.M (2)
    CL Item
    No, Side: Left, Site: Deltoid, Route: S.C (3)
    CL Item
    No, Side: Right, Site: Deltoid, Route: I.M (4)
    CL Item
    No, Side: Right, Site: Deltoid, Route: S.C (5)
    CL Item
    No, Side: Left, Site: Thigh, Route: I:M (6)
    CL Item
    No, Side: Left, Site: Thigh, Route: S.C (7)
    CL Item
    No, Side: Right, Site: Thigh, Route: I.M (8)
    CL Item
    No, Side: Right, Site: Thigh, Route: S.C (9)
    CL Item
    No, Side: Left, Site: Buttock, Route: I.M (10)
    CL Item
    No, Side: Left, Site: Buttock, Route: S.C (11)
    CL Item
    No, Side: Right, Site: Buttock, Route: I.M (12)
    CL Item
    No, Side: Right, Site: Buttock, Route: S.C (13)
    Item
    Vaccine administration DTPa-HBV-IPV Vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C1121707 (UMLS CUI [1,2])
    vaccine administration DTPa-HBV-IPV Vaccine
    Code List
    Vaccine administration DTPa-HBV-IPV Vaccine
    CL Item
    DTPa-HBV-IPV Vaccine (DTPa-HBV-IPV Vaccine)
    CL Item
    Replacement vial (Replacement vial)
    CL Item
    Wrong vial number (Wrong vial number)
    CL Item
    Not administered (Not administered)
    comment
    Item
    If Replacement vial, comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Has the study vaccine been administered according to the Protocol ?
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [1,4])
    vaccine administration site route side
    Code List
    Has the study vaccine been administered according to the Protocol ?
    CL Item
    Yes (1)
    CL Item
    No, Side: Left, Site: Deltoid, Route: I.M (2)
    CL Item
    No, Side: Left, Site: Deltoid, Route: S.C (3)
    CL Item
    No, Side: Right, Site: Deltoid, Route: I.M (4)
    CL Item
    No, Side: Right, Site: Deltoid, Route: S.C (5)
    CL Item
    No, Side: Left, Site: Thigh, Route: I:M (6)
    CL Item
    No, Side: Left, Site: Thigh, Route: S.C (7)
    CL Item
    No, Side: Right, Site: Thigh, Route: I.M (8)
    CL Item
    No, Side: Right, Site: Thigh, Route: S.C (9)
    CL Item
    No, Side: Left, Site: Buttock, Route: I.M (10)
    CL Item
    No, Side: Left, Site: Buttock, Route: S.C (11)
    CL Item
    No, Side: Right, Site: Buttock, Route: I.M (12)
    CL Item
    No, Side: Right, Site: Buttock, Route: S.C (13)
    Item Group
    Vaccine Administration Group Control
    C2368628 (UMLS CUI-1)
    C0009932 (UMLS CUI-2)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    date vaccine administration
    Item
    Please complete only if different from visit date :
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Item
    Vaccine administration MenC Vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C1720015 (UMLS CUI [1,2])
    Vaccine administration Meningococcal vaccine
    Code List
    Vaccine administration MenC Vaccine
    CL Item
    MenC Vaccine (MenC Vaccine)
    CL Item
    Replacement vial (Replacement vial)
    CL Item
    Wrong vial number (Wrong vial number)
    CL Item
    Not administered (Not administered)
    comment
    Item
    If Replacement vial, comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Has the study vaccine been administered according to the Protocol ?
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [1,4])
    vaccine administration site route side
    Code List
    Has the study vaccine been administered according to the Protocol ?
    CL Item
    Yes (1)
    CL Item
    No, Side: Left, Site: Deltoid, Route: I.M (2)
    CL Item
    No, Side: Left, Site: Deltoid, Route: S.C (3)
    CL Item
    No, Side: Right, Site: Deltoid, Route: I.M (4)
    CL Item
    No, Side: Right, Site: Deltoid, Route: S.C (5)
    CL Item
    No, Side: Left, Site: Thigh, Route: I:M (6)
    CL Item
    No, Side: Left, Site: Thigh, Route: S.C (7)
    CL Item
    No, Side: Right, Site: Thigh, Route: I.M (8)
    CL Item
    No, Side: Right, Site: Thigh, Route: S.C (9)
    CL Item
    No, Side: Left, Site: Buttock, Route: I.M (10)
    CL Item
    No, Side: Left, Site: Buttock, Route: S.C (11)
    CL Item
    No, Side: Right, Site: Buttock, Route: I.M (12)
    CL Item
    No, Side: Right, Site: Buttock, Route: S.C (13)
    Item
    Vaccine administration DTPa-HBV-IPV/Hib Vaccine
    text
    C2368628 (UMLS CUI [1,1])
    C1121707 (UMLS CUI [1,2])
    vaccine administration DTPa-HBV-IPV/Hib Vaccine
    Code List
    Vaccine administration DTPa-HBV-IPV/Hib Vaccine
    CL Item
    DTPa-HBV-IPV/Hib Vaccine (DTPa-HBV-IPV/Hib Vaccine)
    CL Item
    Replacement vial (Replacement vial)
    CL Item
    Wrong vial number (Wrong vial number)
    CL Item
    Not administered (Not administered)
    comment
    Item
    If Replacement vial, comment
    text
    C0947611 (UMLS CUI [1])
    Item
    Has the study vaccine been administered according to the Protocol ?
    text
    C2368628 (UMLS CUI [1,1])
    C1515974 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [1,3])
    C0441987 (UMLS CUI [1,4])
    vaccine administration site route side
    Code List
    Has the study vaccine been administered according to the Protocol ?
    CL Item
    Yes (1)
    CL Item
    No, Side: Left, Site: Deltoid, Route: I.M (2)
    CL Item
    No, Side: Left, Site: Deltoid, Route: S.C (3)
    CL Item
    No, Side: Right, Site: Deltoid, Route: I.M (4)
    CL Item
    No, Side: Right, Site: Deltoid, Route: S.C (5)
    CL Item
    No, Side: Left, Site: Thigh, Route: I:M (6)
    CL Item
    No, Side: Left, Site: Thigh, Route: S.C (7)
    CL Item
    No, Side: Right, Site: Thigh, Route: I.M (8)
    CL Item
    No, Side: Right, Site: Thigh, Route: S.C (9)
    CL Item
    No, Side: Left, Site: Buttock, Route: I.M (10)
    CL Item
    No, Side: Left, Site: Buttock, Route: S.C (11)
    CL Item
    No, Side: Right, Site: Buttock, Route: I.M (12)
    CL Item
    No, Side: Right, Site: Buttock, Route: S.C (13)
    Item Group
    Why not administered ?
    C2368628 (UMLS CUI-1)
    C0205544 (UMLS CUI-2)
    Item
    Why not administered ?
    text
    C2368628 (UMLS CUI [1,1])
    C0205544 (UMLS CUI [1,2])
    Vaccine administration cancelled
    Code List
    Why not administered ?
    CL Item
    SAE) Serious adverse event (complete the Serious Adverse Event form (SAE) Serious adverse event (complete the Serious Adverse Event form)
    CL Item
    AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form (AEX) Non-Serious adverse event (complete the Non-serious Adverse Event form)
    CL Item
    OTH) Other (OTH) Other)
    SAE
    Item
    If SAE, Please specify SAE N° :
    text
    C1519255 (UMLS CUI [1])
    non serious adverse event
    Item
    If AEX, Please specify AE N° (Unsolicited) or code (Solicited) : :
    text
    C1518404 (UMLS CUI [1])
    Other
    Item
    If other, please specify
    text
    C0205394 (UMLS CUI [1])
    Item
    Please tick who took the decision :
    text
    C0027361 (UMLS CUI [1])
    person Vaccine administration cancelled
    Code List
    Please tick who took the decision :
    CL Item
    Investigator (Investigator)
    C2826892 (UMLS CUI-1)
    (Comment:en)
    CL Item
    Parents/Guardians (Parents/Guardians)
    C0030551 (UMLS CUI-1)
    (Comment:en)
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