ID
36307
Descripción
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
Palabras clave
Versiones (1)
- 2/5/19 2/5/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de mayo de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Study Conclusion
- StudyEvent: ODM
Descripción
Occurrence of Serious Adverse Event
Alias
- UMLS CUI-1
- C1519255
Descripción
Serious Adverse Event
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1519255
Descripción
Serious Adverse Event, Count of entities
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Descripción
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Descripción
Subject Unblinding Event Record
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C3897431
Descripción
Subject Unblinding Event Record, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Descripción
Subject Unblinding Event Record, Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Descripción
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Descripción
Withdraw
Alias
- UMLS CUI-1
- C2349954
Descripción
Withdraw
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2349954
Descripción
Withdraw, Indication
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Descripción
Withdraw, Indication, Details
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C3146298
- UMLS CUI [1,3]
- C1522508
Descripción
Withdraw, Date last contact
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
Descripción
Withdraw, Date last contact, General physical condition
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0805839
- UMLS CUI [1,3]
- C1142435
Descripción
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Investigator Signature, Date in time
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
Investigator Name
Tipo de datos
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])