ID
34856
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 informed consent has been obtained and to collect the subject's demographic data. 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
Versions (2)
- 1/29/19 1/29/19 -
- 2/1/19 2/1/19 - Sarah Riepenhausen
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
Informed Consent and Demographics
- StudyEvent: ODM
Description
Informed Consent
Alias
- UMLS CUI-1
- C0021430
Description
I certify that Informed Consent has been obtained prior to any study procedure.
Data type
date
Alias
- UMLS CUI [1]
- C0021430
Description
Blood Sample Usage for Further Research
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0008972
- UMLS CUI [2,1]
- C0021403
- UMLS CUI [2,2]
- C0008972
- UMLS CUI [3,1]
- C0021400
- UMLS CUI [3,2]
- C0008972
Description
Demographics
Alias
- UMLS CUI-1
- C1704791
Description
Center Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
Date of Birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Gender
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race
Data type
integer
Alias
- UMLS CUI [1]
- C0034510
Description
Other Specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
- UMLS CUI [1,3]
- C0034510
Similar models
Informed Consent and Demographics
- StudyEvent: ODM
C0008972 (UMLS CUI [1,2])
C0021403 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0021400 (UMLS CUI [3,1])
C0008972 (UMLS CUI [3,2])
C0600091 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0034510 (UMLS CUI [1,3])