ID

35077

Description

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 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"

Link

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

Keywords

Versions (2)
  1. 2/13/19 2/13/19 -
  2. 5/29/19 5/29/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

February 13, 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

Study Conclusion

1 forms  
  1. StudyEvent: ODM
    1. Study Conclusion
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Subject Number
Description

Subject Number

Data type

integer

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

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?
Description

Follow-Up Studies

Data type

boolean

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

if subject not willing to be contacted

Data type

text

Alias
UMLS CUI [1]
C0566251
Please specify
Description

Adverse Events or Serious Adverse Events

Data type

text

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

Other

Data type

text

Alias
UMLS CUI [1]
C0205394
Occurence of SAE
Description

Occurence of SAE

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

Occurence of Serious Adverse Event

Data type

integer

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

If any SAE occurred

Data type

integer

Elimination Criteria
Description

Elimination Criteria

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

Elimination Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
Specify
Description

If any elimination criteria become applicable

Data type

text

Status of Treatment Blind
Description

Status of Treatment Blind

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

Status of Treatment Blind

Data type

boolean

Alias
UMLS CUI [1,1]
C0749659
UMLS CUI [1,2]
C2347038
Complete date and tick one reason below.
Description

If treatment blind was broken

Data type

date

Alias
UMLS CUI [1,1]
C3897431
UMLS CUI [1,2]
C0011008
Complete date and tick one reason below.
Description

If treatment blind was broken

Data type

integer

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

If there was another reason for breaking the treatment blind.

Data type

text

Investigators Signature
Description

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.
Description

Investigator's Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Date

Data type

date

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

Investigators Name

Data type

text

Alias
UMLS CUI [1]
C2826892
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Similar models

Study Conclusion

1 forms
  1. StudyEvent: ODM
    1. Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Item Group
Elimination Criteria
C0680251 (UMLS CUI-1)
Elimination Criteria
Item
Did any elimination criteria become applicable?
boolean
C0680251 (UMLS CUI [1])
Elimination Criteria Specification
Item
Specify
text
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 and tick one reason below.
date
C3897431 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Complete date and tick one reason below.
integer
C3897431 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason Treatment Blind Broken
Code List
Complete date and tick one reason below.
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (9)
Other Specification
Item
Specify
text
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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