ID

34958

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 this form is to document any non-serious adverse events, the subject has experienced during the study. It should be filled out at each visit/contact. All AEs occurring within 30 days following administration of the dose of vaccine must be recorded on the Adverse Event form in the subject's CRF, irrespective of intensity or whether or not they are considered vaccination-related. 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

  1. 2019-02-05 2019-02-05 -
  2. 2019-02-07 2019-02-07 -
  3. 2019-02-08 2019-02-08 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

5 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

Non-Serious Adverse Events

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Assessment Date
Beskrivning

Assessment Date

Datatyp

text

Alias
UMLS CUI [1]
C2985720
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Non-serious Adverse Event
Beskrivning

Non-serious Adverse Event

Alias
UMLS CUI-1
C1518404
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beskrivning

(Please report all serious adverse events only on the Serious Adverse Event (SAE) report). If yes, please complte the following table.

Datatyp

boolean

Alias
UMLS CUI [1]
C1518404
Non-Serious Adverse Event Record
Beskrivning

Non-Serious Adverse Event Record

Alias
UMLS CUI-1
C1518404
Description
Beskrivning

Description

Datatyp

text

Alias
UMLS CUI [1]
C0678257
Administration Site
Beskrivning

Administration Site

Datatyp

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
during immediate postvaccination period (30 minutes)
Beskrivning

NSAE Started Immediately

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0574845
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0205253
Date Stopped
Beskrivning

End date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Beskrivning

Maximum Intensity

Datatyp

text

Alias
UMLS CUI [1]
C1710066
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Beskrivning

Relationship to Investigational Products

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Outcome
Beskrivning

Outcome

Datatyp

integer

Alias
UMLS CUI [1]
C1705586

Similar models

Non-Serious Adverse Events

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Assessment Date
text
C2985720 (UMLS CUI [1])
Code List
Assessment Date
CL Item
Visit 1 (Visit 1)
CL Item
Visit 2 (Visit 2)
CL Item
Telephone Contact (Telephone Contact)
CL Item
Visit 3 (Visit 3)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious Adverse Event
C1518404 (UMLS CUI-1)
Non-serious adverse Event
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
C1518404 (UMLS CUI [1])
Item Group
Non-Serious Adverse Event Record
C1518404 (UMLS CUI-1)
Description
Item
Description
text
C0678257 (UMLS CUI [1])
Item
Administration Site
text
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Code List
Administration Site
CL Item
Administration Site (L)
CL Item
Non-administration Site (G)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
NSAE Started Immediately
Item
during immediate postvaccination period (30 minutes)
boolean
C0574845 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0205253 (UMLS CUI [1,3])
End date
Item
Date Stopped
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710066 (UMLS CUI [1])
Code List
Maximum Intensity
CL Item
Mild (1)
C2945599 (UMLS CUI-1)
(Comment:en)
CL Item
Moderate (2)
C0205081 (UMLS CUI-1)
(Comment:en)
CL Item
Severe (3)
C0205082 (UMLS CUI-1)
(Comment:en)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
text
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product?
CL Item
No (N)
CL Item
Yes (Y)
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Outcome
CL Item
Recovered/Resolved, provide End Date (1)
C1709863 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering/Resolving (2)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered/Resolved with sequelae (4)
C1709862 (UMLS CUI-1)
(Comment:en)

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