ID

36657

Description

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"

Keywords

Versions (2)
  1. 2/22/19 2/22/19 -
  2. 5/29/19 5/29/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 2019

DOI

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License

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

English

Tracking Document

1 forms  
  1. StudyEvent: ODM
    1. Tracking Document
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Previous Subject Number
Description

Previous Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Birth
Description

Date of Birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Center
Description

Center

Data type

integer

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

Date of Contact

Data type

date

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

Reason for Non Participation

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

Reason for Non Participation

Data type

integer

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

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

Data type

text

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

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

Data type

text

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

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

Data type

text

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

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

Data type

date

Alias
UMLS CUI [1]
C1148348
Serious Adverse Event
Description

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)?
Description

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

Data type

boolean

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

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

Data type

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
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Similar models

Tracking Document

1 forms
  1. StudyEvent: ODM
    1. Tracking Document
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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