ID
35255
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 any concimtant vaccination, the subject has received during the study. It should be filled out at each visit/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", GSK-Study-ID 107022.
Keywords
Versions (2)
- 2/13/19 2/13/19 -
- 2/25/19 2/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 25, 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
Concomitant Vaccination
- StudyEvent: ODM
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
If yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Vaccination Record
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0042210
Description
Route
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
Administration date
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Description
For GSK
Data type
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0457083
Similar models
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0457083 (UMLS CUI [1,2])
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