ID

34983

Beskrivning

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to document if returned for study continuation and should be filled out at visit 2. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Länk

https://clinicaltrials.gov/ct2/show/NCT00321373

Nyckelord

Versioner (2)
  1. 2019-02-04 2019-02-04 -
  2. 2019-02-06 2019-02-06 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

6 februari 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Engelsk

Study Continuation

1 Formulär  
  1. StudyEvent: ODM
    1. Study Continuation
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Check for Study Continuation
Beskrivning

Check for Study Continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for visit 2?
Beskrivning

If yes, please complete the next forms, according to the study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0805733
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beskrivning

If subject did not return for study continuation

Datatyp

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify SAE No.
Beskrivning

If SAE was main reason for non-continuation PLease complete and submit SAE report

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Please specify AE No. or solicited AE code.
Beskrivning

Please complete the Non-Serious Adverse Event section

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
UMLS CUI [2,3]
C1521902
Other, please specify
Beskrivning

e.g.: consent withdrawal, Protocol violation

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Please tick who made the decision
Beskrivning

Responsible for Decision

Datatyp

text

Alias
UMLS CUI [1,1]
C1273518
UMLS CUI [1,2]
C0679006
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Similar models

Study Continuation

1 Formulär
  1. StudyEvent: ODM
    1. Study Continuation
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Study Continuation
Item
Did the subject return for visit 2?
boolean
C0008972 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for Non-Continuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Seroius Adverse event (SAE)
CL Item
Non-serious advese event (AEX)
CL Item
Other (OTH)
SAE No.
Item
Please specify SAE No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Serious Adverse Event No.
Item
Please specify AE No. or solicited AE code.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
Other Specification
Item
Other, please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item
Please tick who made the decision
text
C1273518 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Responsible for Decision
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)
Tillbaka till toppen 

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