ID
36322
Beschrijving
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
Trefwoorden
Versies (1)
- 03-05-19 03-05-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
3 mei 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Visit 1 - Day 0
- StudyEvent: ODM
Beschrijving
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C0008976
Beschrijving
Pharmaceutical Preparations
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Immunosuppressive Agents, Chronic
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Beschrijving
Immunoglobulins, Blood Product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Beschrijving
Vaccination, Concomitant Agent,
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschrijving
Vaccination, Concomitant Agent
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschrijving
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
I certify that Informed Consent has been obtained prior to any study procedure.
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pharmaceutical Preparations, Usage
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0457083
Beschrijving
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschrijving
Institution name, Identifier
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
Patient date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Gender
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Ethnic group
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
Racial group
Datatype
text
Alias
- UMLS CUI [1]
- C0034510
Beschrijving
Body Height
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Protocol Compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C0525058
Beschrijving
Gender, Age
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
Childbearing Potential, Absent; Contraceptive methods
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0332197
- UMLS CUI [2]
- C0700589
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Acute Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001314
Beschrijving
Immunologic Deficiency Syndromes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021051
Beschrijving
Hematological Disease
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018939
Beschrijving
Immunosuppressive Agents
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021081
Beschrijving
Demyelinating Diseases
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011303
Beschrijving
nervous system disorder
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027765
Beschrijving
Blood Coagulation Disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005779
Beschrijving
Influenza virus vaccine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021403
Beschrijving
Vaccination, Clinical Trials
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0008976
Beschrijving
Pharmaceutical Preparations
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Pharmaceutical Preparations
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschrijving
Immunoglobulins, Blood product
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Beschrijving
Experimental drug, Hypersensitivity; Egg Food Product, Hypersensitivity; Mercury Compounds, Hypersensitivity
Datatype
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
Beschrijving
Influenza virus vaccine, Serious Adverse Event
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C1519255
Beschrijving
Breast Feeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006147
Beschrijving
Study Subject Participation Status, Inappropriate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1548788
Beschrijving
Randomisation / Treatment Allocation
Alias
- UMLS CUI-1
- C0034656
Beschrijving
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschrijving
Disease; Symptoms
Datatype
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1457887
Beschrijving
MedDRA System Organ Class
Datatype
text
Alias
- UMLS CUI [1]
- C2347091
Beschrijving
Diagnosis
Datatype
text
Alias
- UMLS CUI [1]
- C0011900
Beschrijving
Diagnosis, Past, Current
Datatype
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
- UMLS CUI [1,3]
- C0521116
Beschrijving
Laboratory Tests - Blood Sample
Alias
- UMLS CUI-1
- C0005834
Beschrijving
Collection of blood specimen for laboratory procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0005834
Beschrijving
Collection of blood specimen for laboratory procedure, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschrijving
HCG Urine Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Beschrijving
Urine pregnancy test
Datatype
text
Alias
- UMLS CUI [1]
- C0430056
Beschrijving
Urine pregnancy test, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Beschrijving
Urine pregnancy test, Result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Beschrijving
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Beschrijving
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Beschrijving
Influenza virus vaccine, Previous
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Beschrijving
Influenza virus vaccine, Previous
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Beschrijving
Vaccine Administration
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C2368628
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0011008
Beschrijving
Influenza virus vaccine, Body Temperature, Vaccination, Before
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0005903
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0332152
Beschrijving
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Beschrijving
Influenza virus vaccine, Administration of Vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Vial Device, Replacement, Numbers
Datatype
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
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Protocol Compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0525058
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Side
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0441987
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Anatomic site
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Drug Administration Routes
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Not done
Datatype
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Beschrijving
Influenza virus vaccine, Administration of Vaccine, Decision
Datatype
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])