ID

35252

Descrição

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.

Palavras-chave

Versões (2)
  1. 22/02/2019 22/02/2019 -
  2. 25/02/2019 25/02/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de fevereiro de 2019

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

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

Inglês

Elimination Criteria

1 Formulários  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Assessment Date
Descrição

Assessment Date

Tipo de dados

date

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

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.
Descrição

Use of Investigational or Non-Registered Product

Tipo de dados

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.)
Descrição

Chronic Administation of Immunosuppressants or Immune-Modifying Drugs

Tipo de dados

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
Descrição

Other Recent Vaccination

Tipo de dados

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.
Descrição

Administratino of Flu Vaccine

Tipo de dados

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.
Descrição

Administration of Immunoglobulins or Blood Products

Tipo de dados

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.
Descrição

Confirmed or Suspected Immunosuppressive or Immunodeficient Condition

Tipo de dados

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
Voltar ao início da página

Similar models

Elimination Criteria

1 Formulários
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial