ID

34868

Description

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 the subject has had any past influenza vaccinations. It should be filled out at visit 1. 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

Keywords

  1. 1/31/19 1/31/19 -
  2. 2/1/19 2/1/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 1, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

History of Influenza Vaccination

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Assessment Date
Description

Assessment Date

Data type

date

Alias
UMLS CUI [1]
C2985720
History of Influenza Vaccination
Description

History of Influenza Vaccination

Alias
UMLS CUI-1
C0042200
UMLS CUI-2
C0262926
Has the subject been vaccinated against influenza within the last three seasons?
Description

If yes, tick all that apply for specification

Data type

boolean

Alias
UMLS CUI [1]
C0586139
Season 2003 – 2004
Description

Season

Data type

boolean

Alias
UMLS CUI [1,1]
C0036497
UMLS CUI [1,2]
C0021403
Season 2004 – 2005
Description

Season

Data type

boolean

Alias
UMLS CUI [1,1]
C0036497
UMLS CUI [1,2]
C0021403
Season 2005 – 2006
Description

Season

Data type

boolean

Alias
UMLS CUI [1,1]
C0036497
UMLS CUI [1,2]
C0021403

Similar models

History of Influenza Vaccination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Assessment Date
Item
Assessment Date
date
C2985720 (UMLS CUI [1])
Item Group
History of Influenza Vaccination
C0042200 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
History of Influenza Vaccination
Item
Has the subject been vaccinated against influenza within the last three seasons?
boolean
C0586139 (UMLS CUI [1])
Season
Item
Season 2003 – 2004
boolean
C0036497 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
Season
Item
Season 2004 – 2005
boolean
C0036497 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
Season
Item
Season 2005 – 2006
boolean
C0036497 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial