ID
35181
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 following criteria should be checked at each visit/contact subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis. 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
Link
https://clinicaltrials.gov/ct2/show/NCT00321373
Keywords
Versions (3)
- 2/13/19 2/13/19 -
- 2/22/19 2/22/19 -
- 2/25/19 2/25/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 22, 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 NCT00321373
Elimination Criteria
- StudyEvent: ODM
Description
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Description
Use of Investigational or Non-Registered Product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0013230
Description
Immunosuppressants or Immune-Modifying Drugs During Study Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [1,3]
- C2347804
- UMLS CUI [1,4]
- C0347984
- UMLS CUI [2,1]
- C0005525
- UMLS CUI [2,2]
- C0205191
- UMLS CUI [2,3]
- C2347804
- UMLS CUI [2,4]
- C0347984
- UMLS CUI [3,1]
- C2064827
- UMLS CUI [3,2]
- C0332300
- UMLS CUI [4,1]
- C2065041
- UMLS CUI [4,2]
- C0332300
Description
Other Recent Vaccination
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0332185
Description
Administratino of Flu Vaccine
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042200
- UMLS CUI [1,2]
- C1533734
Description
Immunoglobulins or Blood Products During Study Period
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C2347804
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [2,1]
- C0371802
- UMLS CUI [2,2]
- C2347804
- UMLS CUI [2,3]
- C0347984
Description
Confirmed or Suspected Immunosuppressive or Immunodeficient Condition
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0750484
- UMLS CUI [1,2]
- C3829792
- UMLS CUI [2,1]
- C4048329
- UMLS CUI [2,2]
- C0242114
- UMLS CUI [3,1]
- C0750484
- UMLS CUI [3,2]
- C4048329
- UMLS CUI [4,1]
- C3829792
- UMLS CUI [4,2]
- C0242114
Similar models
Elimination Criteria
- StudyEvent: ODM
C0008976 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0347984 (UMLS CUI [2,4])
C2064827 (UMLS CUI [3,1])
C0332300 (UMLS CUI [3,2])
C2065041 (UMLS CUI [4,1])
C0332300 (UMLS CUI [4,2])
C0205394 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0371802 (UMLS CUI [2,1])
C2347804 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C3829792 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C4048329 (UMLS CUI [3,2])
C3829792 (UMLS CUI [4,1])
C0242114 (UMLS CUI [4,2])