ID

35178

Beskrivning

Study ID: 107022 Clinical Study ID: 107022 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 Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations 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"

Länk

https://clinicaltrials.gov/ct2/show/NCT00321373

Nyckelord

Versioner (2)
  1. 2019-02-22 2019-02-22 -
  2. 2019-05-29 2019-05-29 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

22 februari 2019

DOI

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Licens

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

Engelsk

Tracking Document

1 Formulär  
  1. StudyEvent: ODM
    1. Tracking Document
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Previous Subject Number
Beskrivning

Previous Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Center
Beskrivning

Center

Datatyp

integer

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

Date of Contact

Datatyp

date

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

Reason for Non Participation

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

Reason for Non Participation

Datatyp

integer

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

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

Datatyp

text

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

Adverse Event or Serious Adverse Event Specification

Datatyp

text

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

Other Specification

Datatyp

text

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

Date the Subject Died

Datatyp

date

Alias
UMLS CUI [1]
C1148348
Serious Adverse Event
Beskrivning

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)?
Beskrivning

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

Datatyp

boolean

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

Number of SAEs

Datatyp

integer

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

Tracking Document

1 Formulär
  1. StudyEvent: ODM
    1. Tracking Document
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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)
CL Item
Subject los to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate due to adverse event (3)
CL Item
Subject eligible but not willing to participate due to other reason (4)
CL Item
Subject died (5)
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])
Tillbaka till toppen 

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