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ID

33322

Descrição

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

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Versões (1)
  1. 05/12/2018 05/12/2018 -
Titular dos direitos

GSK group of companies

Transferido a

5 de dezembro de 2018

DOI

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Licença

Creative Commons BY-NC 3.0
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    Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

    Inglês

    Visit 1: Vaccine Administration

    1 Formulários  
    Administrative data
    Descrição

    Administrative data

    Subject Number
    Descrição

    Subject Number

    Tipo de dados

    integer

    Protocol number
    Descrição

    Protocol number

    Tipo de dados

    integer

    Vaccine Administration
    Descrição

    Vaccine Administration

    Date
    Descrição

    Date

    Tipo de dados

    date

    Pre-Vaccination temperature
    Descrição

    Pre-Vaccination temperature

    Tipo de dados

    float

    Unidades de medida
    • °C
    °C
    Route
    Descrição

    Route

    Tipo de dados

    text

    Vaccine Administration
    Descrição

    Vaccine Administration

    tick only one box:
    Descrição

    tick only one box:

    Tipo de dados

    text

    Replacement vial number
    Descrição

    if applies

    Tipo de dados

    integer

    Wrong vial number
    Descrição

    If applies

    Tipo de dados

    integer

    Administration side/site/route
    Descrição

    Administration side/site/route

    Side and site
    Descrição

    Side and site

    Tipo de dados

    text

    Route
    Descrição

    Route

    Tipo de dados

    text

    Administration according to protocol
    Descrição

    Administration according to protocol

    Has the study vaccine been administered according to the Protocol?
    Descrição

    Has the study vaccine been administered according to the Protocol?

    Tipo de dados

    text

    Side
    Descrição

    Side

    Tipo de dados

    text

    Site
    Descrição

    Site

    Tipo de dados

    text

    Route
    Descrição

    Route

    Tipo de dados

    text

    Non-administration
    Descrição

    Non-administration

    Why was vaccine not administered?
    Descrição

    please tick ONE most appropriate category for non admonistration

    Tipo de dados

    text

    If Other, please specify
    Descrição

    e.g., consent withdrawal, protocol violation

    Tipo de dados

    text

    If SAE, please specify SAE number
    Descrição

    If SAE, please specify SAE number

    Tipo de dados

    integer

    If Non-SAE, please specify unsolicited AE number
    Descrição

    If Non-SAE, please specify unsolicited AE number

    Tipo de dados

    integer

    Please tick who took the decision
    Descrição

    Please tick who took the decision

    Tipo de dados

    text

    Immediate Post-Vaccination Observation
    Descrição

    Immediate Post-Vaccination Observation

    If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
    Descrição

    If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.

    Tipo de dados

    text

    If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
    Descrição

    If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.

    Tipo de dados

    text

    Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
    Descrição

    Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

    Tipo de dados

    text

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    Visit 1: Vaccine Administration

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    Administrative data
    Subject Number
    Item
    Subject Number
    integer
    Protocol number
    Item
    Protocol number
    integer
    Item Group
    Vaccine Administration
    Date
    Item
    Date
    date
    Pre-Vaccination temperature
    Item
    Pre-Vaccination temperature
    float
    Item
    Route
    text
    Route
    Code List
    Route
    CL Item
    Axillary (1)
    CL Item
    Oral (2)
    CL Item
    Tympanic (oral conversion) (3)
    CL Item
    Tympanic (rectal conversion) (4)
    CL Item
    Rectal (5)
    Item Group
    Vaccine Administration
    Item
    tick only one box:
    text
    tick only one box:
    Code List
    tick only one box:
    CL Item
    Plain PRP Vaccine (1)
    CL Item
    Replacement vial (2)
    CL Item
    Wrong vial number (3)
    CL Item
    Not administered (4)
    Replacement vial number
    Item
    Replacement vial number
    integer
    Wrong vial number
    Item
    Wrong vial number
    integer
    Item Group
    Administration side/site/route
    Item
    Side and site
    text
    Side and site
    Code List
    Side and site
    CL Item
    Upper right thigh (1)
    Item
    Route
    text
    Route
    Code List
    Route
    CL Item
    IM (1)
    Item Group
    Administration according to protocol
    Item
    Has the study vaccine been administered according to the Protocol?
    text
    Has the study vaccine been administered according to the Protocol?
    Code List
    Has the study vaccine been administered according to the Protocol?
    CL Item
    Yes (1)
    CL Item
    No -> please tick all below items that apply (2)
    Item
    Side
    text
    Side
    Code List
    Side
    CL Item
    Upper left (1)
    CL Item
    Lower left (2)
    CL Item
    Upper right (3)
    CL Item
    Lower right (4)
    Item
    Site
    text
    Site
    Code List
    Site
    CL Item
    Deltoid (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item
    Route
    text
    Route
    Code List
    Route
    CL Item
    I.M. (1)
    CL Item
    S.C. (2)
    Item Group
    Non-administration
    Item
    Why was vaccine not administered?
    text
    Why was vaccine not administered?
    Code List
    Why was vaccine not administered?
    CL Item
    Serious Adverse Event (1)
    CL Item
    Non-Serious Adverse Event  (2)
    CL Item
    Other (3)
    If Other, please specify
    Item
    If Other, please specify
    text
    If SAE, please specify SAE number
    Item
    If SAE, please specify SAE number
    integer
    If Non-SAE, please specify unsolicited AE number
    Item
    If Non-SAE, please specify unsolicited AE number
    integer
    Item
    Please tick who took the decision
    text
    Please tick who took the decision
    Code List
    Please tick who took the decision
    CL Item
    Investigator (1)
    CL Item
    Parents/Guardians (2)
    Item Group
    Immediate Post-Vaccination Observation
    If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
    Item
    If any AE occurred during the immediate post-vaccination time (30 min), please fill in the Solicited Adverse Events section, the Non-SAE section or a SAE section.
    text
    If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
    Item
    If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick "Prophylactic" box.
    text
    Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
    Item
    Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
    text
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