ID

35246

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)
  1. 2/13/19 2/13/19 -
  2. 2/22/19 2/22/19 -
  3. 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 NCT00321373

English

Elimination Criteria

1 forms  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
Type of Visit
Description

Type of Visit

Data type

text

Alias
UMLS CUI [1,1]
C3641100
UMLS CUI [1,2]
C0008976
Elimination Criteria During the Study
Description

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Description

Use of Investigational or Non-Registered Product

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
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
Administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination and within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior the last study visit at Day 180
Description

Other Recent Vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0332185
Administration of a Flu vaccine during the study period.
Description

Administration of Flu Vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0347984
UMLS CUI [1,5]
C2347804
Administration of immunoglobulins and/or any blood products during the study period.
Description

Immunoglobulins or Blood Products During Study Period

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0371802
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C2347804
Newly confirmed or suspected immunosuppressive or immunodeficient condition.
Description

Confirmed or Suspected Immunosuppressive or Immunodeficient Condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0021051
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0242114
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C4048329
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0242114
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Similar models

Elimination Criteria

1 forms
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Type of Visit
Item
Type of Visit
text
C3641100 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
Use of Investigational or Non-Registered Product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Immunosuppressants or Immune-Modifying Drugs During Study Period
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
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])
Other Recent Vaccination
Item
Administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination and within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior the last study visit at Day 180
boolean
C0042196 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Administration of Flu Vaccine
Item
Administration of a Flu vaccine during the study period.
boolean
C0042200 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C2347804 (UMLS CUI [1,5])
Immunoglobulins or Blood Products During Study Period
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0371802 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
Confirmed or Suspected Immunosuppressive or Immunodeficient Condition
Item
Newly confirmed or suspected immunosuppressive or immunodeficient condition.
boolean
C0750484 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C4048329 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0750484 (UMLS CUI [3,1])
C4048329 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0242114 (UMLS CUI [4,2])
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