ID

35255

Beschreibung

Study ID: 107191 Clinical Study ID: 107191 Study Title: A Phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years. Patient Level Data: NA Clinicaltrials.gov Identifier: NA EudraCT Number: 2006-000939-97 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza The purpose of this form is to document any concimtant vaccination, the subject has received during the study. It should be filled out at each visit/contact. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1 Visit 1 and 2 are part of the study: "Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373", GSK-Study-ID 107022.

Stichworte

  1. 13.02.19 13.02.19 -
  2. 25.02.19 25.02.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0

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    Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix EudraCT Number 2006-000939-97

    Concomitant Vaccination

    Administrative Data
    Beschreibung

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beschreibung

    Subject Number

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Vaccination
    Beschreibung

    Concomitant Vaccination

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    Beschreibung

    If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0042196
    UMLS CUI [1,2]
    C2347852
    Concomitant Vaccination Record
    Beschreibung

    Concomitant Vaccination Record

    Alias
    UMLS CUI-1
    C0042196
    UMLS CUI-2
    C2347852
    Trade/Generic Name
    Beschreibung

    Name

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0027365
    UMLS CUI [1,2]
    C0042210
    Route
    Beschreibung

    Route

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013153
    UMLS CUI [1,2]
    C0042210
    Administration date
    Beschreibung

    Administration date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1533734
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0042210
    For GSK
    Beschreibung

    For GSK

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0008961
    UMLS CUI [1,2]
    C0457083

    Ähnliche Modelle

    Concomitant Vaccination

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Vaccination
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Item
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    integer
    C0042196 (UMLS CUI [1,1])
    C2347852 (UMLS CUI [1,2])
    Code List
    Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
    CL Item
    No (1)
    CL Item
    Yes (2)
    Item Group
    Concomitant Vaccination Record
    C0042196 (UMLS CUI-1)
    C2347852 (UMLS CUI-2)
    Name
    Item
    Trade/Generic Name
    text
    C0027365 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Item
    Route
    text
    C0013153 (UMLS CUI [1,1])
    C0042210 (UMLS CUI [1,2])
    Code List
    Route
    CL Item
    Intradermal (ID)
    CL Item
    Inhalation (IH)
    CL Item
    Intramuscular (IM)
    CL Item
    Intravenous (IV)
    CL Item
    Intranasal (NA)
    CL Item
    Other (OTH)
    CL Item
    Parenteral (PE)
    CL Item
    Oral (PO)
    CL Item
    Subcutaneous (SC)
    CL Item
    Sublingual (SL)
    CL Item
    Transdermal (TD)
    CL Item
    Unknown (UNK)
    Administration date
    Item
    Administration date
    date
    C1533734 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0042210 (UMLS CUI [1,3])
    For GSK
    Item
    For GSK
    text
    C0008961 (UMLS CUI [1,1])
    C0457083 (UMLS CUI [1,2])

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