ID

36657

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 purpose of this form is to document the reason for the subjects non-participation and if the subject has had any SAEs since the last 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"

Palavras-chave

Versões (2)
  1. 22/02/2019 22/02/2019 -
  2. 29/05/2019 29/05/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

29 de maio 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

Tracking Document

1 Formulários  
  1. StudyEvent: ODM
    1. Tracking Document
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Previous Subject Number
Descrição

Previous Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Date of Birth
Descrição

Date of Birth

Tipo de dados

date

Alias
UMLS CUI [1]
C0421451
Center
Descrição

Center

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Contact
Descrição

Date of Contact

Tipo de dados

date

Alias
UMLS CUI [1]
C0805839
Reason for Non Participation
Descrição

Reason for Non Participation

Alias
UMLS CUI-1
C0558080
UMLS CUI-2
C0679823
UMLS CUI-3
C0392360
Please document reason for non participation
Descrição

Reason for Non Participation

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0679823
UMLS CUI [1,3]
C0392360
please specify criteria that are not fullfilled
Descrição

If main reason for non-participation was that the subject was not eligible

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3242266
UMLS CUI [1,2]
C2348235
Adverse Event or Serious Adverse Event Specification
Descrição

If main reason for non-participation was a (serious) adverse event.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C2348235
please specify
Descrição

If main reason for non-participation was an other reason.

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Subject died on
Descrição

If main reason for non-participation was that the subject died.

Tipo de dados

date

Alias
UMLS CUI [1]
C1148348
Serious Adverse Event
Descrição

Serious Adverse Event

Alias
UMLS CUI-1
C1519255
Has the subject had any serious adverse event since the phone contact, day 30 (FLU-LD-001)?
Descrição

If yes, check the following items and check SAE forms have been submitted to GSK Biologicals.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1519255
Specify number of SAEs
Descrição

If subject experienced any serious adverse events since the phone contact on day 30 (FLU-LD-001).

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Voltar ao início da página

Similar models

Tracking Document

1 Formulários
  1. StudyEvent: ODM
    1. Tracking Document
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Previous Subject Number
Item
Previous Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Center
Item
Center
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of Contact
Item
Date of Contact
date
C0805839 (UMLS CUI [1])
Item Group
Reason for Non Participation
C0558080 (UMLS CUI-1)
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
Item
Please document reason for non participation
integer
C0558080 (UMLS CUI [1,1])
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
Reason for Non Participation
Code List
Please document reason for non participation
CL Item
Subject not Eligible (1)
(Comment:en)
CL Item
Subject lost to follow-up or not reached (2)
(Comment:en)
CL Item
Subject eligible but not willing to participate due to adverse event (3)
(Comment:en)
CL Item
Subject eligible but not willing to participate due to other reason (4)
(Comment:en)
CL Item
Subject died (5)
(Comment:en)
Specification Criteria Not Fulfilled
Item
please specify criteria that are not fullfilled
text
C3242266 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Adverse Event or Serious Adverse Event Specification
Item
Adverse Event or Serious Adverse Event Specification
text
C1519255 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other Specification
Item
please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date the Subject Died
Item
Subject died on
date
C1148348 (UMLS CUI [1])
Item Group
Serious Adverse Event
C1519255 (UMLS CUI-1)
Serious Adverse Event
Item
Has the subject had any serious adverse event since the phone contact, day 30 (FLU-LD-001)?
boolean
C1519255 (UMLS CUI [1])
Number of SAEs
Item
Specify number of SAEs
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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