Information:
Error:
ID
35599
Description
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza
Keywords
Versions (1)
- 3/11/19 3/11/19 -
Copyright Holder
GSK group of companies
Uploaded on
March 11, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631
Concomitant Medication, Non-Serious Adverse Events, Study Conclusion
Similar models
Concomitant Medication, Non-Serious Adverse Events, Study Conclusion
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Subject Number
Item
Subject Number
integer
Comcomitant Medication Question
Item
Have any vaccines other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Other (6)
CL Item
Parenteral (7)
CL Item
Oral (8)
CL Item
Subcutaneous (9)
CL Item
Sublingual (10)
CL Item
Transdermal (11)
CL Item
Unknown (12)
Administration date
Item
Administration date
date
Concomitant Medication Question
Item
Have any medications/treatments been administered during the timeframe as specified in the Protocol?
boolean
Trade / Generic Name
Item
Trade / Generic Name
text
Medical Indication
Item
Medical Indication
text
Prophylactic
Item
Prophylactic?
boolean
Total daily dose
Item
Total daily dose
text
CL Item
External (1)
CL Item
Intradermal (2)
CL Item
Inhalation (3)
CL Item
Intramuscular (4)
CL Item
Intraarticular (5)
CL Item
Intrathecal (6)
CL Item
Intravenous (7)
CL Item
Intranasal (8)
CL Item
Other (9)
CL Item
Parenteral (10)
CL Item
Oral (11)
CL Item
Rectal (12)
CL Item
Subcutaneous (13)
CL Item
Sublingual (14)
CL Item
Transdermal (15)
CL Item
Topical (16)
CL Item
Unknown (17)
CL Item
Vaginal (18)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing
Item
Ongoing?
boolean
Non-Serious Adverse Events Question
Item
Has any non-serious adverse events occurred between Visit "Day 0" and Visit "Day 21", excluding those recorded on the Solicited Adverse Events pages?
boolean
AE No.
Item
AE No.
integer
Description
Item
Description:
text
CL Item
Administration site (1)
CL Item
Non-administration site (2)
Date Started
Item
Date Started:
date
Date Stopped
Item
Date Stopped:
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit:
boolean
CL Item
Hospitalisation (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Occurrence of serious adverse event
Item
Did the subject experience any Serious Adverse Event during the study?
boolean
total number of SAE's
Item
Specify total number of SAE's
integer
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Elimination Criteria Question
Item
Did any elimination criteria become applicable during the study?
boolean
If Yes, specify
Item
If Yes, specify
text
subject withdrawal
Item
Was the subject withdrawn from the study?
boolean
CL Item
Serious adverse event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Protocol violation (3)
CL Item
Consent withdrawal, not due to an adverse event (4)
CL Item
Migrated / moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
SAE No.
Item
Please specify SAE No.
integer
AE No.
Item
Please specify AE No.
integer
Protocol violation specify
Item
If Protocol violation, please specify
text
Specify Other
Item
If Other, specify
text
CL Item
Investigator (1)
CL Item
Subject (2)
Date of last contact
Item
Date of last contact:
date
Subject in good condition
Item
Was the subject in good condition at date of last contact?
boolean
Investigator's Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature:
text
Printed Investigator's name:
Item
Printed Investigator's name:
text
Centre
Item
Centre
integer
Use of Human Samples by GSK
Item
In addition to the use of samples for the tests described in the protocol, samples might be used for other resarch by GSK (see protocol). Please tick what is also covered by the subject Informed Consent form of your center.
text
Quality Assurance of tests described in the protocol
Item
Quality Assurance of tests described in the protocol
boolean
Further investigations
Item
Further investigation by GSK Biologicals into the ability of Fluarix TM vaccine to protect people if any findings from related studies require it and further research in Influenza disease under study.
boolean
Subject's permission
Item
Investigator will always ask in advance the permission of the independent Ethics Committee/Institutional Review Board linked to the institution where this research is performed.
boolean
Further research not related to current study
Item
Further research by GSK Biologicals that is NOT RELATED to Fluarix TM vaccine or Influenza disease under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed).
boolean
Item
Please tick below box if a 15 years GSK storage period is covered by the subjects Informed Consent form of your center.
text
Code List
Please tick below box if a 15 years GSK storage period is covered by the subjects Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
ICF Effective date
Item
ICF Effective date:
date
Investigator’s signature
Item
Investigator’s signature:
text
Printed Investigator’s name
Item
Printed Investigator’s name:
text
Date
Item
Date:
date