ID

36294

Description

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

Keywords

Versions (1)
  1. 4/30/19 4/30/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 30, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469

English

Medication

1 forms  
  1. StudyEvent: ODM
    1. Medication
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Medication
Description

Medication

Alias
UMLS CUI-1
C0013227
Have any medications/treatments been administered during the timeframe as specified in the Protocol?
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Trade / Generic Name
Description

Pharmaceutical Preparations, Medication name

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2360065
Medical Indication
Description

Pharmaceutical Preparations, Indication

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3146298
Total daily dose
Description

Pharmaceutical Preparations, Daily Dose, Total

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route
Description

Pharmaceutical Preparations, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0013153
Start Date
Description

Pharmaceutical Preparations, Start Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Description

Pharmaceutical Preparations, End Date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Tick box if continuing at end of study
Description

Pharmaceutical Preparations, Continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
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Similar models

Medication

1 forms
  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Pharmaceutical Preparations
Item
Have any medications/treatments been administered during the timeframe as specified in the Protocol?
boolean
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations, Medication name
Item
Trade / Generic Name
text
C0013227 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Pharmaceutical Preparations, Indication
Item
Medical Indication
text
C0013227 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Pharmaceutical Preparations, Daily Dose, Total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Pharmaceutical Preparations, Drug Administration Routes
Item
Route
text
C0013227 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Pharmaceutical Preparations, Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations, End Date
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations, Continuous
Item
Tick box if continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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