ID

34983

Descripción

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

Link

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

Palabras clave

Versiones (2)
  1. 4/2/19 4/2/19 -
  2. 6/2/19 6/2/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

6 de febrero de 2019

DOI

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Licencia

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

Inglés

Study Continuation

1 formularios  
  1. StudyEvent: ODM
    1. Study Continuation
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descripción

Subject Number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Descripción

Date of Visit

Tipo de datos

date

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

Check for Study Continuation

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

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

Tipo de datos

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.
Descripción

If subject did not return for study continuation

Tipo de datos

text

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

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

Tipo de datos

integer

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

Please complete the Non-Serious Adverse Event section

Tipo de datos

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
Descripción

e.g.: consent withdrawal, Protocol violation

Tipo de datos

text

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

Responsible for Decision

Tipo de datos

text

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

Study Continuation

1 formularios
  1. StudyEvent: ODM
    1. Study Continuation
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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