ID

35252

Beschrijving

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.

Trefwoorden

Versies (2)
  1. 22-02-19 22-02-19 -
  2. 25-02-19 25-02-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

25 februari 2019

DOI

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Licentie

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

Engels

Elimination Criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

Subject Number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Assessment Date
Beschrijving

Assessment Date

Datatype

date

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

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.
Beschrijving

Use of Investigational or Non-Registered Product

Datatype

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.)
Beschrijving

Chronic Administation of Immunosuppressants or Immune-Modifying Drugs

Datatype

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
Beschrijving

Other Recent Vaccination

Datatype

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.
Beschrijving

Administratino of Flu Vaccine

Datatype

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.
Beschrijving

Administration of Immunoglobulins or Blood Products

Datatype

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.
Beschrijving

Confirmed or Suspected Immunosuppressive or Immunodeficient Condition

Datatype

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
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Similar models

Elimination Criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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