ID

36658

Beschreibung

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 conclude the study. It should be filled out at the phone contact and rechecked at visit 3. 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"

Stichworte

Versionen (2)
  1. 13.02.19 13.02.19 -
  2. 29.05.19 29.05.19 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

29. Mai 2019

DOI

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Lizenz

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

Englisch

Study Conclusion

1 Formulare  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Beschreibung

Assessment Date

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Follow-Up Studies
Beschreibung

Follow-Up Studies

Alias
UMLS CUI-1
C0016441
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
Beschreibung

Follow-Up Studies

Datentyp

boolean

Alias
UMLS CUI [1]
C0016441
Please specify the most appropriate reason
Beschreibung

if subject not willing to be contacted

Datentyp

text

Alias
UMLS CUI [1]
C0566251
Please specify
Beschreibung

If reason for not willing to be contacted was a (serious) adverse event.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
Please specify
Beschreibung

If there was another reason for not willing to be contacted.

Datentyp

text

Alias
UMLS CUI [1]
C0205394
Occurence of SAE
Beschreibung

Occurence of SAE

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2745955
Did the subject experience any Serious Adverse Event?
Beschreibung

Occurence of Serious Adverse Event

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2745955
Specify total number of SAE's
Beschreibung

If any SAE occurred

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Elimination Criteria
Beschreibung

Elimination Criteria

Alias
UMLS CUI-1
C0680251
Did any elimination criteria become applicable?
Beschreibung

Elimination Criteria

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Specify
Beschreibung

If any elimination criteria become applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C1521902
Status of Treatment Blind
Beschreibung

Status of Treatment Blind

Alias
UMLS CUI-1
C0749659
UMLS CUI-2
C2347038
Was the treatment blind broken during the study?
Beschreibung

Status of Treatment Blind

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Complete date treatment blind was broken
Beschreibung

If treatment blind was broken

Datentyp

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Tick one reason below for breaking treatment blind.
Beschreibung

If treatment blind was broken

Datentyp

integer

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
Specify
Beschreibung

If there was another reason for breaking the treatment blind.

Datentyp

text

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Investigators Signature
Beschreibung

Investigators Signature

Alias
UMLS CUI-1
C2346576
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Beschreibung

Investigator's Signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Printed Investigator's name
Beschreibung

Investigators Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Study Conclusion

1 Formulare
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-Up Studies
C0016441 (UMLS CUI-1)
Follow-Up Studies
Item
If a booster study or a follow-up study is offered in the future, would the subject be willing to be contacted and learn more about it?
boolean
C0016441 (UMLS CUI [1])
Item
Please specify the most appropriate reason
text
C0566251 (UMLS CUI [1])
Reason
Code List
Please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events (Adverse Events, or Serious Adverse Events)
CL Item
Other (Other)
Adverse Events or Serious Adverse Events
Item
Please specify
text
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Other
Item
Please specify
text
C0205394 (UMLS CUI [1])
Item Group
Occurence of SAE
C1519255 (UMLS CUI-1)
C2745955 (UMLS CUI-2)
Occurence of Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event?
integer
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Number of SAE's
Item
Specify total number of SAE's
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Elimination Criteria
Item
Did any elimination criteria become applicable?
boolean
C0680251 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Elimination Criteria Specification
Item
Specify
text
C0680251 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
Item Group
Status of Treatment Blind
C0749659 (UMLS CUI-1)
C2347038 (UMLS CUI-2)
Status of Treatment Blind
Item
Was the treatment blind broken during the study?
boolean
C0749659 (UMLS CUI [1,1])
C2347038 (UMLS CUI [1,2])
Date Treatment Blind Broken
Item
Complete date treatment blind was broken
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Tick one reason below for breaking treatment blind.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason Treatment Blind Broken
Code List
Tick one reason below for breaking treatment blind.
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (9)
Other Specification
Item
Specify
text
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item Group
Investigators Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigators Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
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