ID
35831
Description
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Use of human samples by GSK form.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Keywords
Versions (1)
- 3/25/19 3/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 25, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Use of human samples by GSK
- StudyEvent: ODM
Description
Use of human samples by GSK
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0457083
Description
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.
Data type
boolean
Alias
- UMLS CUI [1]
- C0178932
Description
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457083
- UMLS CUI [1,2]
- C0005522
- UMLS CUI [1,3]
- C0021403
- UMLS CUI [2,1]
- C0457083
- UMLS CUI [2,2]
- C0005522
- UMLS CUI [2,3]
- C4316910
- UMLS CUI [3,1]
- C1298908
- UMLS CUI [3,2]
- C1320549
- UMLS CUI [4,1]
- C1298908
- UMLS CUI [4,2]
- C1321876
Description
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing), independent Ethics Committee
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457083
- UMLS CUI [1,2]
- C0005522
- UMLS CUI [1,3]
- C0021403
- UMLS CUI [2,1]
- C0457083
- UMLS CUI [2,2]
- C0005522
- UMLS CUI [2,3]
- C4316910
- UMLS CUI [3,1]
- C1298908
- UMLS CUI [3,2]
- C1320549
- UMLS CUI [4,1]
- C1298908
- UMLS CUI [4,2]
- C1321876
- UMLS CUI [5,1]
- C0332158
- UMLS CUI [5,2]
- C0086911
Description
Use of Biologicals for further research NOT RELATED influenza vaccine/disease (excluding genetics and HIV testing)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0457083
- UMLS CUI [1,2]
- C0005522
- UMLS CUI [1,3]
- C1546988
- UMLS CUI [1,4]
- C0021403
- UMLS CUI [2,1]
- C0457083
- UMLS CUI [2,2]
- C0005522
- UMLS CUI [2,3]
- C1546988
- UMLS CUI [2,4]
- C4316910
- UMLS CUI [3,1]
- C3858751
- UMLS CUI [3,2]
- C0039593
- UMLS CUI [4,1]
- C1298908
- UMLS CUI [4,2]
- C1320549
- UMLS CUI [5,1]
- C1298908
- UMLS CUI [5,2]
- C1321876
Description
GSK storage period, informed consent form
Data type
integer
Alias
- UMLS CUI [1,1]
- C1698986
- UMLS CUI [1,2]
- C0449238
- UMLS CUI [1,3]
- C0370003
Description
Other GSK storage period
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C0449238
- UMLS CUI [1,4]
- C0370003
Description
day month year. Complete and submit a new form for each change during the study
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator’s name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Use of human samples by GSK
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0457083 (UMLS CUI-2)
C0005522 (UMLS CUI [1,2])
C0021403 (UMLS CUI [1,3])
C0457083 (UMLS CUI [2,1])
C0005522 (UMLS CUI [2,2])
C4316910 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C1320549 (UMLS CUI [3,2])
C1298908 (UMLS CUI [4,1])
C1321876 (UMLS CUI [4,2])
C0005522 (UMLS CUI [1,2])
C0021403 (UMLS CUI [1,3])
C0457083 (UMLS CUI [2,1])
C0005522 (UMLS CUI [2,2])
C4316910 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C1320549 (UMLS CUI [3,2])
C1298908 (UMLS CUI [4,1])
C1321876 (UMLS CUI [4,2])
C0332158 (UMLS CUI [5,1])
C0086911 (UMLS CUI [5,2])
C0005522 (UMLS CUI [1,2])
C1546988 (UMLS CUI [1,3])
C0021403 (UMLS CUI [1,4])
C0457083 (UMLS CUI [2,1])
C0005522 (UMLS CUI [2,2])
C1546988 (UMLS CUI [2,3])
C4316910 (UMLS CUI [2,4])
C3858751 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
C1298908 (UMLS CUI [4,1])
C1320549 (UMLS CUI [4,2])
C1298908 (UMLS CUI [5,1])
C1321876 (UMLS CUI [5,2])
C0449238 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,4])
C0009797 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])