ID

35252

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 following criteria should be checked at each visit/contact subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis. 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

Versionen (2)
  1. 22.02.19 22.02.19 -
  2. 25.02.19 25.02.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

25. Februar 2019

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

Elimination Criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Elimination Criteria During the Study
Beschreibung

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Beschreibung

Use of Investigational or Non-Registered Product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, equal to 0.5 mg/kg/day or more. Inhaled and topical steroids are allowed.)
Beschreibung

Chronic Administation of Immunosuppressants or Immune-Modifying Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C2064827
UMLS CUI [3,2]
C0332300
UMLS CUI [4,1]
C2065041
UMLS CUI [4,2]
C0332300
Administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination and within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior the last study visit at Day 180
Beschreibung

Other Recent Vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332185
Administration of a Flu vaccine during the study period.
Beschreibung

Administratino of Flu Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C2347804
Administration of immunoglobulins and/or any blood products during the study period.
Beschreibung

Administration of Immunoglobulins or Blood Products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0371802
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Newly confirmed or suspected immunosuppressive or immunodeficient condition.
Beschreibung

Confirmed or Suspected Immunosuppressive or Immunodeficient Condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0021051
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0242114
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C4048329
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0242114
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Elimination Criteria

1 Formulare
  1. StudyEvent: ODM
    1. Elimination Criteria
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])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
Use of Investigational or Non-Registered Product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Chronic Administation of Immunosuppressants or Immune-Modifying Drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, equal to 0.5 mg/kg/day or more. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2064827 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
Other Recent Vaccination
Item
Administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination and within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior the last study visit at Day 180
boolean
C0042196 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Administratino of Flu Vaccine
Item
Administration of a Flu vaccine during the study period.
boolean
C0042200 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Administration of Immunoglobulins or Blood Products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0371802 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Confirmed or Suspected Immunosuppressive or Immunodeficient Condition
Item
Newly confirmed or suspected immunosuppressive or immunodeficient condition.
boolean
C0750484 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C4048329 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0242114 (UMLS CUI [4,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video