ID
35021
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 this form is to conclude the study. It should be filled out at the phone contact and rechecked at visit 3. 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)
- 2/8/19 2/8/19 -
- 2/10/19 2/10/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 10, 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
Study Conclusion
- StudyEvent: ODM
Description
Occurence of SAE
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2745955
Description
Elimination Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Subject Withdrawal
Alias
- UMLS CUI-1
- C0422727
Description
Study Withdrawal
Data type
integer
Alias
- UMLS CUI [1]
- C0422727
Description
If subject was withdrawn from the study Tick one box only
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
Applies If SAE was the major reason for withdrawal Please complete and submit SAE report
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Applies if non-serious adverse event was major reason for withdrawal Please complete Non-serious Adverse Event section
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Applies if non-serious adverse event was major reason for withdrawal
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0805701
Description
If protocol violation was major reason for withdrawal
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
If there was another major reason for withdrawal
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C2348235
Description
Decision
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
Date of Last Contact
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If no, please give details in adverse events section
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0805839
- UMLS CUI [1,2]
- C1142435
Description
Investigators Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigators Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Similar models
Study Conclusion
- StudyEvent: ODM
C2745955 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,2])