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)
- 2/22/19 2/22/19 -
- 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
Tracking Document
- StudyEvent: ODM
Description
Reason for Non Participation
Alias
- UMLS CUI-1
- C0558080
- UMLS CUI-2
- C0679823
- UMLS CUI-3
- C0392360
Description
Reason for Non Participation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0558080
- UMLS CUI [1,2]
- C0679823
- UMLS CUI [1,3]
- C0392360
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
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
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
Description
If main reason for non-participation was that the subject died.
Data type
date
Alias
- UMLS CUI [1]
- C1148348
Description
Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
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
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
Similar models
Tracking Document
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0679823 (UMLS CUI-2)
C0392360 (UMLS CUI-3)
C0679823 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])