ID

36312

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)
  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

Engelsk

Visit 2 - Day 21

1 Formulär  
  1. StudyEvent: ODM
    1. Visit 2 - Day 21
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for Visit 2 "Day 21"?
Beskrivning

Continuation status, Clinical Trials

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

Continuation status, Clinical Trials, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Specify
Beskrivning

Continuation status, Clinical Trials, Reason

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0566251
Please tick who made the decision
Beskrivning

Continuation status, Clinical Trials, Decision

Datatyp

text

Alias
UMLS CUI [1,1]
C0805733
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0679006
Laboratory Tests - Blood Sample
Beskrivning

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken for serology?
Beskrivning

Collection of blood specimen for laboratory procedure

Datatyp

text

Alias
UMLS CUI [1]
C0005834
Date if different from visit date
Beskrivning

Collection of blood specimen for laboratory procedure, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
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Similar models

Visit 2 - Day 21

1 Formulär
  1. StudyEvent: ODM
    1. Visit 2 - Day 21
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Continuation status, Clinical Trials
Item
Did the subject return for Visit 2 "Day 21"?
boolean
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Item
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
If No, Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (Please specify SAE N°) (1)
CL Item
Non-Serious adverse event (Please specify unsolicited AE N° or solicited AE code) (2)
CL Item
Other, please specify (e.g. consent withdrawal, Protocol violation, ...) (3)
Item
Specify
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Reason
Code List
Specify
Item
Please tick who made the decision
text
C0805733 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Continuation status, Clinical Trials, Decision
Code List
Please tick who made the decision
CL Item
Investigator  (1)
CL Item
Subject (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Item
Has a blood sample been taken for serology?
text
C0005834 (UMLS CUI [1])
Collection of blood specimen for laboratory procedure
Code List
Has a blood sample been taken for serology?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (Subject not in the immuno subset) (3)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Tillbaka till toppen 

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