ID
36307
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)
- 02.05.19 02.05.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
2. 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
Study Conclusion
- StudyEvent: ODM
Beschreibung
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Serious Adverse Event
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Serious Adverse Event, Count of entities
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschreibung
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschreibung
Subject Unblinding Event Record
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschreibung
Subject Unblinding Event Record, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschreibung
Subject Unblinding Event Record, Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschreibung
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
Withdraw
Alias
- UMLS CUI-1
- C2349954
Beschreibung
Withdraw
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2349954
Beschreibung
Withdraw, Indication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beschreibung
Withdraw, Indication, Details
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Beschreibung
Withdraw, Date last contact
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Beschreibung
Withdraw, Date last contact, General physical condition
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator Signature, Date in time
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Beschreibung
Investigator Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Ähnliche Modelle
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])