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33322

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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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  1. 05/12/18 05/12/18 -
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GSK group of companies

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5 dicembre 2018

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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

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    Subject Number

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    Protocol number

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    Vaccine Administration
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    Vaccine Administration

    Date
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    Date

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    Pre-Vaccination temperature
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    Pre-Vaccination temperature

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    °C
    Route
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    Route

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    Vaccine Administration
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    Vaccine Administration

    tick only one box:
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    tick only one box:

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    text

    Replacement vial number
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    if applies

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    integer

    Wrong vial number
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    If applies

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    integer

    Administration side/site/route
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    Administration side/site/route

    Side and site
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    text

    Route
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    Route

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    text

    Administration according to protocol
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    Administration according to protocol

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

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    Side
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    Non-administration
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    Non-administration

    Why was vaccine not administered?
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    please tick ONE most appropriate category for non admonistration

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    e.g., consent withdrawal, protocol violation

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    Tipo di dati

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    Please tick who took the decision
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    Please tick who took the decision

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    Immediate Post-Vaccination Observation
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    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.
    Descrizione

    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 di dati

    text

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

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

    Tipo di dati

    text

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

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

    Tipo di dati

    text

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    Visit 1: Vaccine Administration

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    Subject Number
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    Vaccine Administration
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    Axillary (1)
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    Oral (2)
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    Tympanic (oral conversion) (3)
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    Tympanic (rectal conversion) (4)
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    Rectal (5)
    Item Group
    Vaccine Administration
    Item
    tick only one box:
    text
    tick only one box:
    Code List
    tick only one box:
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    Plain PRP Vaccine (1)
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    Replacement vial (2)
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    Wrong vial number (3)
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    Not administered (4)
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    IM (1)
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    text
    Has the study vaccine been administered according to the Protocol?
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    Has the study vaccine been administered according to the Protocol?
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    Yes (1)
    CL Item
    No -> please tick all below items that apply (2)
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    integer
    If Non-SAE, please specify unsolicited AE number
    Item
    If Non-SAE, please specify unsolicited AE number
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    Item
    Please tick who took the decision
    text
    Please tick who took the decision
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    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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