ID
35831
Beschrijving
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
Trefwoorden
Versies (1)
- 25-03-19 25-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 maart 2019
DOI
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Licentie
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
Beschrijving
Use of human samples by GSK
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0457083
Beschrijving
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.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0178932
Beschrijving
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing)
Datatype
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
Beschrijving
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing), independent Ethics Committee
Datatype
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
Beschrijving
Use of Biologicals for further research NOT RELATED influenza vaccine/disease (excluding genetics and HIV testing)
Datatype
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
Beschrijving
GSK storage period, informed consent form
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1698986
- UMLS CUI [1,2]
- C0449238
- UMLS CUI [1,3]
- C0370003
Beschrijving
Other GSK storage period
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1698986
- UMLS CUI [1,3]
- C0449238
- UMLS CUI [1,4]
- C0370003
Beschrijving
day month year. Complete and submit a new form for each change during the study
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009797
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
Investigator's Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Printed Investigator’s name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
day month year
Datatype
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])