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42319

Descrizione

Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

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versioni (1)
  1. 29/05/21 29/05/21 -
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GlaxoSmithKline

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29 maggio 2021

DOI

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Creative Commons BY 4.0
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    Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840

    Inglese

    Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

    1 moduli  
    Administrative
    Descrizione

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Descrizione

    Subject Number

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    General Medical History/ Physical Examination
    Descrizione

    General Medical History/ Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
    Descrizione

    If Yes, please give diagnosis and tick appropriate Past/Current box(es).

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2]
    C0037088
    General Medical History/ Physical Examination
    Descrizione

    General Medical History/ Physical Examination

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    MedDRA System Organ Class
    Descrizione

    MedDRA System Organ Class

    Tipo di dati

    integer

    Alias
    UMLS CUI [1]
    C2347091
    Diagnosis
    Descrizione

    Diagnosis

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0011900
    Disease Status
    Descrizione

    Disease Status

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0449438
    Laboratory Tests
    Descrizione

    Laboratory Tests

    Alias
    UMLS CUI-1
    C0022885
    Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
    Descrizione

    Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0003241
    UMLS CUI [3]
    C0021400
    HI Antibody Determination Date
    Descrizione

    Please complete only if different from visit date

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0003241
    UMLS CUI [1,2]
    C0021400
    UMLS CUI [2,1]
    C1148554
    UMLS CUI [2,2]
    C0011008
    Vaccine Administration
    Descrizione

    Vaccine Administration

    Alias
    UMLS CUI-1
    C2368628
    Date of Vaccine Administration
    Descrizione

    (fill in only if different from visit date)

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C2368628
    Pre-Vaccination temperature
    Descrizione

    Pre-Vaccination temperature

    Tipo di dati

    float

    Unità di misura
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    UMLS CUI [2,1]
    C0042196
    UMLS CUI [2,2]
    C0332152
    °C
    Temperatur measurement route
    Descrizione

    Temperatur measurement route

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0449444
    Vaccine Administration
    Descrizione

    Vaccine Administration

    Alias
    UMLS CUI-1
    C2368628
    Vaccine Administration
    Descrizione

    Vaccine Administration

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2368628
    Replacement vial number
    Descrizione

    Replacement vial number

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C0559956
    UMLS CUI [1,3]
    C0600091
    Wrong vial number
    Descrizione

    Wrong vial number

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0184301
    UMLS CUI [1,2]
    C3827420
    UMLS CUI [1,3]
    C0600091
    Has the study vaccine been administered according to the Protocol?
    Descrizione

    Has the study vaccine been administered according to the Protocol?

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2368628
    UMLS CUI [2]
    C2348563
    If study vaccine has not been administered according to the Protocol, specify Side
    Descrizione

    If study vaccine has not been administered according to the Protocol, specify Side

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0441987
    If study vaccine has not been administered according to the Protocol, specify Site
    Descrizione

    If study vaccine has not been administered according to the Protocol, specify Site

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C1515974
    If study vaccine has not been administered according to the Protocol, specify Route
    Descrizione

    If study vaccine has not been administered according to the Protocol, specify Route

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C2368628
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0013153
    Please tick the major reason for non administration
    Descrizione

    Please tick the major reason for non administration

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0392360
    UMLS CUI [1,3]
    C1272696
    Please specify SAE No.
    Descrizione

    Please specify SAE No.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0237753
    Please specify AE No.
    Descrizione

    Please specify AE No.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C1518404
    UMLS CUI [1,2]
    C0237753
    Specify other reason for non administration
    Descrizione

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

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C1533734
    UMLS CUI [2,1]
    C0392360
    UMLS CUI [2,2]
    C1272696
    UMLS CUI [3]
    C0205394
    UMLS CUI [4]
    C2348235
    Please tick who made decision (for non administration)
    Descrizione

    Please tick who made decision (for non administration)

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0679006
    UMLS CUI [2,1]
    C1533734
    UMLS CUI [2,2]
    C1272696
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    Similar models

    Visit 1, Day 0 Vaccination: General Medical History/ Physical Examination; Laboratory Tests; Vaccine Administration

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    General Medical History/ Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
    Item
    Are you aware of any pre-existing conditions, signs or symptoms present history since Day 180 of FLU-LD-006 EXT-002 (D180) study?
    boolean
    C0012634 (UMLS CUI [1])
    C0037088 (UMLS CUI [2])
    Item Group
    General Medical History/ Physical Examination
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Item
    MedDRA System Organ Class
    integer
    C2347091 (UMLS CUI [1])
    MedDRA System Organ Class
    Code List
    MedDRA System Organ Class
    CL Item
    Skin and subcutaneous tissue (1)
    CL Item
    Musculoskeletal and connective tissue (2)
    CL Item
    Cardiac (3)
    CL Item
    Vascular (4)
    CL Item
    Respiratory, thoracic and mediastinal (5)
    CL Item
    Gastrointestinal (6)
    CL Item
    Hepatobiliary (7)
    CL Item
    Renal and urinary (8)
    CL Item
    Nervous system (9)
    CL Item
    Eye (10)
    CL Item
    Ear and labyrinth (11)
    CL Item
    Endocrine (12)
    CL Item
    Metabolism and nutrition (13)
    CL Item
    Blood and lymphatic system (14)
    CL Item
    Immune system (incl allergies, autoimmune disorders) (15)
    CL Item
    Infections and infestations (16)
    CL Item
    Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
    CL Item
    Surgical and medical procedures (18)
    CL Item
    Other (19)
    Diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    Item
    Disease Status
    integer
    C0012634 (UMLS CUI [1,1])
    C0449438 (UMLS CUI [1,2])
    Disease Status
    Code List
    Disease Status
    CL Item
    Past (1)
    CL Item
    Current (2)
    Item Group
    Laboratory Tests
    C0022885 (UMLS CUI-1)
    Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
    Item
    Blood Sample - HI Antibody Determination: Has a blood sample been taken for (serum) HI antibody determination?
    boolean
    C0005834 (UMLS CUI [1])
    C0003241 (UMLS CUI [2])
    C0021400 (UMLS CUI [3])
    HI Antibody Determination Date
    Item
    HI Antibody Determination Date
    date
    C0003241 (UMLS CUI [1,1])
    C0021400 (UMLS CUI [1,2])
    C1148554 (UMLS CUI [2,1])
    C0011008 (UMLS CUI [2,2])
    Item Group
    Vaccine Administration
    C2368628 (UMLS CUI-1)
    Date of Vaccine Administration
    Item
    Date of Vaccine Administration
    date
    C0011008 (UMLS CUI [1,1])
    C2368628 (UMLS CUI [1,2])
    Pre-Vaccination temperature
    Item
    Pre-Vaccination temperature
    float
    C0005903 (UMLS CUI [1])
    C0042196 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    Item
    Temperatur measurement route
    text
    C0886414 (UMLS CUI [1,1])
    C0449444 (UMLS CUI [1,2])
    Temperatur measurement route
    Code List
    Temperatur measurement route
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (not recommended) (R)
    Item Group
    Vaccine Administration
    C2368628 (UMLS CUI-1)
    Item
    Vaccine Administration
    text
    C2368628 (UMLS CUI [1])
    Vaccine Administration
    Code List
    Vaccine Administration
    CL Item
    Study Vaccine (S)
    CL Item
    Replacement vial (R)
    CL Item
    Wrong vial number (W)
    CL Item
    Not administered (Please complete following pages) (N)
    Replacement vial number
    Item
    Replacement vial number
    text
    C0184301 (UMLS CUI [1,1])
    C0559956 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Wrong vial number
    Item
    Wrong vial number
    text
    C0184301 (UMLS CUI [1,1])
    C3827420 (UMLS CUI [1,2])
    C0600091 (UMLS CUI [1,3])
    Has the study vaccine been administered according to the Protocol?
    Item
    Has the study vaccine been administered according to the Protocol?
    boolean
    C2368628 (UMLS CUI [1])
    C2348563 (UMLS CUI [2])
    Item
    If study vaccine has not been administered according to the Protocol, specify Side
    text
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0441987 (UMLS CUI [2])
    If study vaccine has not been administered according to the Protocol, specify Side
    Code List
    If study vaccine has not been administered according to the Protocol, specify Side
    CL Item
    Dominant (D)
    CL Item
    Non dominant (N)
    Item
    If study vaccine has not been administered according to the Protocol, specify Site
    integer
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C1515974 (UMLS CUI [2])
    If study vaccine has not been administered according to the Protocol, specify Site
    Code List
    If study vaccine has not been administered according to the Protocol, specify Site
    CL Item
    Deltoid (1)
    CL Item
    Thigh (2)
    CL Item
    Buttock (3)
    Item
    If study vaccine has not been administered according to the Protocol, specify Route
    text
    C2368628 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0013153 (UMLS CUI [2])
    If study vaccine has not been administered according to the Protocol, specify Route
    Code List
    If study vaccine has not been administered according to the Protocol, specify Route
    CL Item
    I.M. (IM)
    CL Item
    S.C. (SC)
    Item
    Please tick the major reason for non administration
    text
    C1533734 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    C1272696 (UMLS CUI [1,3])
    Please tick the major reason for non administration
    Code List
    Please tick the major reason for non administration
    CL Item
    Serious adverse event (Please complete and submit SAE report) (SAE)
    CL Item
    Non-Serious adverse event (Please complete Non-Serious Adverse Event section) (AEX)
    CL Item
    Other, please specify (OTH)
    Please specify SAE No.
    Item
    Please specify SAE No.
    text
    C1519255 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Please specify AE No.
    Item
    Please specify AE No.
    text
    C1518404 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Specify other reason for non administration
    Item
    Specify other reason for non administration
    text
    C1533734 (UMLS CUI [1])
    C0392360 (UMLS CUI [2,1])
    C1272696 (UMLS CUI [2,2])
    C0205394 (UMLS CUI [3])
    C2348235 (UMLS CUI [4])
    Item
    Please tick who made decision (for non administration)
    text
    C0679006 (UMLS CUI [1])
    C1533734 (UMLS CUI [2,1])
    C1272696 (UMLS CUI [2,2])
    Please tick who made decision (for non administration)
    Code List
    Please tick who made decision (for non administration)
    CL Item
    Investigator (I)
    CL Item
    Subject (S)
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