ID
36307
Beskrivning
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
Nyckelord
Versioner (1)
- 2019-05-02 2019-05-02 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 maj 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Study Conclusion
- StudyEvent: ODM
Beskrivning
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Serious Adverse Event, Count of entities
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beskrivning
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beskrivning
Subject Unblinding Event Record
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beskrivning
Subject Unblinding Event Record, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beskrivning
Subject Unblinding Event Record, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beskrivning
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Withdraw
Alias
- UMLS CUI-1
- C2349954
Beskrivning
Withdraw
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beskrivning
Withdraw, Indication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beskrivning
Withdraw, Indication, Details
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beskrivning
Withdraw, Date last contact
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beskrivning
Withdraw, Date last contact, General physical condition
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator Signature, Date in time
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigator Name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion
- StudyEvent: ODM
C0449788 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C3146298 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0805839 (UMLS CUI [1,2])
C0805839 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])