ID

35006

Descrição

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

Link

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

Palavras-chave

  1. 05/02/2019 05/02/2019 -
  2. 07/02/2019 07/02/2019 -
  3. 08/02/2019 08/02/2019 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

8 de fevereiro de 2019

DOI

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Licença

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
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

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

Non-serious Adverse Event

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

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

Tipo de dados

boolean

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

Non-Serious Adverse Event Record

Alias
UMLS CUI-1
C1518404
AE No.
Descrição

AE No.

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Description
Descrição

Description

Tipo de dados

text

Alias
UMLS CUI [1]
C0678257
Administration Site
Descrição

Administration Site

Tipo de dados

text

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

Start Date

Tipo de dados

date

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

NSAE Started Immediately

Tipo de dados

boolean

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

End date

Tipo de dados

date

Alias
UMLS CUI [1]
C0806020
Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

text

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

Relationship to Investigational Products

Tipo de dados

text

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

Outcome

Tipo de dados

integer

Alias
UMLS CUI [1]
C1705586
For GSK
Descrição

Comment

Tipo de dados

text

Alias
UMLS CUI [1]
C0947611

Similar models

Non-Serious Adverse Events

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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 event 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)
AE No.
Item
AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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 (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)
Comment
Item
For GSK
text
C0947611 (UMLS CUI [1])

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