ID

36310

Description

Study ID: 111258 Clinical Study ID: 111258 Study Title: A phase IV, observer-blind, randomized single-dose post-marketing study to compare the safety and immunogenicity of Fluviral Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) made with new vs. aged bulk material, in adults ranging in age from 18 to 60 Years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00586469 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Influenza Vaccine Trade Name: Fluviral Study Indication: Influenza

Keywords

Versions (1)
  1. 5/2/19 5/2/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 2, 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.

Back to model comments
Itemgroup comments for :

Item comments for :

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

Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469

English

Use of Human Samples by GSK

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Centre
Description

Study Coordinating Centre

Data type

text

Alias
UMLS CUI [1]
C2825181
Use of Human Samples by GSK
Description

Use of Human Samples by GSK

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0457083
In addition to the use of samples for the tests described in the protocol, samples might be used for other research by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
Description

Laboratory Procedures, Usage

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0457083
Please tick below box if a 15 years GSK storage period is covered by the subjectís Informed Consent form of your center.
Description

Laboratory Procedures, Storage, Duration

Data type

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0449238
ICF Effective date
Description

Pharmaceutical Procedures, Usage, Informed Consent, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0457083
UMLS CUI [1,3]
C0021430
UMLS CUI [1,4]
C0011008
Investigator's Signature
Description

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's signature
Description

Investigator Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date
Description

Investigator Signature, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Printed Investigator's name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Back to the top of the page

Similar models

Use of Human Samples by GSK

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study Coordinating Centre
Item
Centre
text
C2825181 (UMLS CUI [1])
Item Group
Use of Human Samples by GSK
C0022885 (UMLS CUI-1)
C0457083 (UMLS CUI-2)
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other research by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
Laboratory Procedures, Usage
Code List
In addition to the use of samples for the tests described in the protocol, samples might be used for other research by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
CL Item
Quality Assurance of tests described in the protocol. This may include the management of the quality of these current tests, the maintenance or improvement of these current tests, the development of new test methods for the markers described in the protocol as well as making sure that new tests are comparable to previous methods and work reliably. (1)
CL Item
Further investigation by GSK Biologicals into the ability of Fluviral vaccine to protect people if any findings from related studies require it and further research in Influenza disease under study. These investigations excludes genetics and HIV testing. (2)
CL Item
Further investigation by GSK Biologicals into the ability of Fluviral vaccine to protect people if any findings from related studies require it and further research in Influenza disease under study. These investigations excludes genetics and HIV testing. (3)
CL Item
Further research by GSK Biologicals that is NOT RELATED to Fluviral vaccine or Influenza disease under study done on an anonymous basis (meaning that any identification linking (4)
CL Item
he subject to the sample is destroyed). This research excludes genetic and HIV testing and does not affect subject participation in the study. (he subject to the sample is destroyed). This research excludes genetic and HIV testing and does not affect subject participation in the study.)
Item
Please tick below box if a 15 years GSK storage period is covered by the subjectís Informed Consent form of your center.
text
C0022885 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Laboratory Procedures, Storage, Duration
Code List
Please tick below box if a 15 years GSK storage period is covered by the subjectís Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other, specify (2)
Pharmaceutical Procedures, Usage, Informed Consent, Date in time
Item
ICF Effective date
date
C0022885 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator Signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Investigator Signature, Date in time
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator Name
Item
Printed Investigator's name
text
C2826892 (UMLS CUI [1])
Back to the top of the page 

Contact

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

Fields marked with * are required.

Help

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