ID
36322
Beschreibung
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
Stichworte
Versionen (1)
- 03.05.19 03.05.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Mai 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Visit 1 - Day 0
- StudyEvent: ODM
Beschreibung
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C0347984
- UMLS CUI-3
- C0008976
Beschreibung
Pharmaceutical Preparations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Immunosuppressive Agents, Chronic
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
Beschreibung
Immunoglobulins, Blood Product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Beschreibung
Vaccination, Concomitant Agent,
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschreibung
Vaccination, Concomitant Agent
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschreibung
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
I certify that Informed Consent has been obtained prior to any study procedure.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschreibung
Pharmaceutical Preparations, Usage
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0457083
Beschreibung
Demographics
Alias
- UMLS CUI-1
- C1704791
Beschreibung
Institution name, Identifier
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschreibung
Patient date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Gender
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnic group
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Racial group
Datentyp
text
Alias
- UMLS CUI [1]
- C0034510
Beschreibung
Body Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschreibung
Body Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Eligibility Check
Alias
- UMLS CUI-1
- C0013893
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
Protocol Compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0525058
Beschreibung
Gender, Age
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0079399
- UMLS CUI [1,2]
- C0001779
Beschreibung
Informed Consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
Childbearing Potential, Absent; Contraceptive methods
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3831118
- UMLS CUI [1,2]
- C0332197
- UMLS CUI [2]
- C0700589
Beschreibung
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Acute Disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001314
Beschreibung
Immunologic Deficiency Syndromes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021051
Beschreibung
Hematological Disease
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0018939
Beschreibung
Immunosuppressive Agents
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021081
Beschreibung
Demyelinating Diseases
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011303
Beschreibung
nervous system disorder
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0027765
Beschreibung
Blood Coagulation Disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005779
Beschreibung
Influenza virus vaccine
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021403
Beschreibung
Vaccination, Clinical Trials
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0008976
Beschreibung
Pharmaceutical Preparations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Pharmaceutical Preparations
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Immunoglobulins, Blood product
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021027
- UMLS CUI [1,2]
- C0456388
Beschreibung
Experimental drug, Hypersensitivity; Egg Food Product, Hypersensitivity; Mercury Compounds, Hypersensitivity
Datentyp
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
Beschreibung
Influenza virus vaccine, Serious Adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C1519255
Beschreibung
Breast Feeding
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006147
Beschreibung
Study Subject Participation Status, Inappropriate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1548788
Beschreibung
Randomisation / Treatment Allocation
Alias
- UMLS CUI-1
- C0034656
Beschreibung
General Medical History / Physical Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Beschreibung
Disease; Symptoms
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C1457887
Beschreibung
MedDRA System Organ Class
Datentyp
text
Alias
- UMLS CUI [1]
- C2347091
Beschreibung
Diagnosis
Datentyp
text
Alias
- UMLS CUI [1]
- C0011900
Beschreibung
Diagnosis, Past, Current
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0011900
- UMLS CUI [1,2]
- C1444637
- UMLS CUI [1,3]
- C0521116
Beschreibung
Laboratory Tests - Blood Sample
Alias
- UMLS CUI-1
- C0005834
Beschreibung
Collection of blood specimen for laboratory procedure
Datentyp
text
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Collection of blood specimen for laboratory procedure, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Beschreibung
HCG Urine Pregnancy Test
Alias
- UMLS CUI-1
- C0430056
Beschreibung
Urine pregnancy test
Datentyp
text
Alias
- UMLS CUI [1]
- C0430056
Beschreibung
Urine pregnancy test, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C0011008
Beschreibung
Urine pregnancy test, Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430056
- UMLS CUI [1,2]
- C1274040
Beschreibung
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Beschreibung
History of Influenza Vaccination
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C0205156
Beschreibung
Influenza virus vaccine, Previous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Beschreibung
Influenza virus vaccine, Previous
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0205156
Beschreibung
Vaccine Administration
Alias
- UMLS CUI-1
- C0021403
- UMLS CUI-2
- C2368628
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0011008
Beschreibung
Influenza virus vaccine, Body Temperature, Vaccination, Before
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C0005903
- UMLS CUI [1,3]
- C0042196
- UMLS CUI [1,4]
- C0332152
Beschreibung
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Beschreibung
Influenza virus vaccine, Administration of Vaccine
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Vial Device, Replacement, Numbers
Datentyp
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
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
- UMLS CUI [1,4]
- C0013153
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Protocol Compliance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0525058
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Side
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0441987
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Anatomic site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1515974
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Drug Administration Routes
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0013153
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Not done
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C1272696
Beschreibung
Influenza virus vaccine, Administration of Vaccine, Decision
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021403
- UMLS CUI [1,2]
- C2368628
- UMLS CUI [1,3]
- C0679006
Ähnliche Modelle
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])