ID
36322
Description
Study ID: 111258 Clinical Study ID: 111258 Study Title: A phase IV, observer-blind, randomized single-dose post-marketing study to compare the safety and immunogenicity of Fluviral Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) made with new vs. aged bulk material, in adults ranging in age from 18 to 60 Years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00586469 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Influenza Vaccine Trade Name: Fluviral Study Indication: Influenza
Keywords
Versions (1)
- 5/3/19 5/3/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 3, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Visit 1 - Day 0
- StudyEvent: ODM
Description
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C0008976
Description
Pharmaceutical Preparations
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Immunosuppressive Agents, Chronic
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Description
Immunoglobulins, Blood Product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Description
Vaccination, Concomitant Agent,
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Description
Vaccination, Concomitant Agent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
I certify that Informed Consent has been obtained prior to any study procedure.
Data type
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Description
Pharmaceutical Preparations, Usage
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0457083
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Institution name, Identifier
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Patient date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnic group
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
Racial group
Data type
text
Alias
- UMLS CUI [1]
- C0034510
Description
Body Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Body Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Protocol Compliance
Data type
boolean
Alias
- UMLS CUI [1]
- C0525058
Description
Gender, Age
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
Description
Informed Consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
Childbearing Potential, Absent; Contraceptive methods
Data type
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0332197
- UMLS CUI [2]
- C0700589
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Acute Disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0001314
Description
Immunologic Deficiency Syndromes
Data type
boolean
Alias
- UMLS CUI [1]
- C0021051
Description
Hematological Disease
Data type
boolean
Alias
- UMLS CUI [1]
- C0018939
Description
Immunosuppressive Agents
Data type
boolean
Alias
- UMLS CUI [1]
- C0021081
Description
Demyelinating Diseases
Data type
boolean
Alias
- UMLS CUI [1]
- C0011303
Description
nervous system disorder
Data type
boolean
Alias
- UMLS CUI [1]
- C0027765
Description
Blood Coagulation Disorders
Data type
boolean
Alias
- UMLS CUI [1]
- C0005779
Description
Influenza virus vaccine
Data type
boolean
Alias
- UMLS CUI [1]
- C0021403
Description
Vaccination, Clinical Trials
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0008976
Description
Pharmaceutical Preparations
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Pharmaceutical Preparations
Data type
boolean
Alias
- UMLS CUI [1]
- C0013227
Description
Immunoglobulins, Blood product
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Description
Experimental drug, Hypersensitivity; Egg Food Product, Hypersensitivity; Mercury Compounds, Hypersensitivity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [2,1]
- C0013710
- UMLS CUI [2,2]
- C0020517
- UMLS CUI [3,1]
- C3536917
- UMLS CUI [3,2]
- C0020517
Description
Influenza virus vaccine, Serious Adverse Event
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C1519255
Description
Breast Feeding
Data type
boolean
Alias
- UMLS CUI [1]
- C0006147
Description
Study Subject Participation Status, Inappropriate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1548788
Description
Randomisation / Treatment Allocation
Alias
- UMLS CUI-1
- C0034656
Description
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Description
Disease; Symptoms
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1457887
Description
MedDRA System Organ Class
Data type
text
Alias
- UMLS CUI [1]
- C2347091
Description
Diagnosis
Data type
text
Alias
- UMLS CUI [1]
- C0011900
Description
Diagnosis, Past, Current
Data type
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
- UMLS CUI [1,3]
- C0521116
Description
Laboratory Tests - Blood Sample
Alias
- UMLS CUI-1
- C0005834
Description
Collection of blood specimen for laboratory procedure
Data type
text
Alias
- UMLS CUI [1]
- C0005834
Description
Collection of blood specimen for laboratory procedure, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Description
HCG Urine Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Description
Urine pregnancy test
Data type
text
Alias
- UMLS CUI [1]
- C0430056
Description
Urine pregnancy test, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Description
Urine pregnancy test, Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Description
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Description
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Description
Influenza virus vaccine, Previous
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Description
Influenza virus vaccine, Previous
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Description
Vaccine Administration
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C2368628
Description
Influenza virus vaccine, Administration of Vaccine, Date in time
Data type
date
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0011008
Description
Influenza virus vaccine, Body Temperature, Vaccination, Before
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0005903
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0332152
Description
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Description
Influenza virus vaccine, Administration of Vaccine
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
Description
Influenza virus vaccine, Administration of Vaccine, Vial Device, Replacement, Numbers
Data type
integer
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0184301
- UMLS CUI [1,4]
- C0559956
- UMLS CUI [1,5]
- C0600091
Description
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Description
Influenza virus vaccine, Administration of Vaccine, Protocol Compliance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0525058
Description
Influenza virus vaccine, Administration of Vaccine, Side
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0441987
Description
Influenza virus vaccine, Administration of Vaccine, Anatomic site
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
Description
Influenza virus vaccine, Administration of Vaccine, Drug Administration Routes
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Description
Influenza virus vaccine, Administration of Vaccine, Not done
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Description
Influenza virus vaccine, Administration of Vaccine, Decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0679006
Similar models
Visit 1 - Day 0
- StudyEvent: ODM
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0205191 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C0008976 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
C0020517 (UMLS CUI [1,2])
C0013710 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C3536917 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C1519255 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0031809 (UMLS CUI-2)
C1457887 (UMLS CUI [2])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0205156 (UMLS CUI-2)
C0205156 (UMLS CUI-2)
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
C2368628 (UMLS CUI-2)
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])