ID

35831

Descrição

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

Palavras-chave

Versões (1)
  1. 25/03/2019 25/03/2019 -
Titular dos direitos

GlaxoSmithKline

Transferido a

25 de março de 2019

DOI

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Licença

Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874

Inglês

Use of human samples by GSK

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Descrição

Centre Number

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Use of human samples by GSK
Descrição

Use of human samples by GSK

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0457083
Quality Assurance of tests described in the protocol
Descrição

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.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0178932
Further investigation by GSK Biologicals into the ability of influenza 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.
Descrição

Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing)

Tipo de dados

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
Further investigation by GSK Biologicals into the ability of influenza vaccine to protect people if any findings from related studies require it and further research in influenza disease under study. These investigations excludes genetic and HIV testing. 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.
Descrição

Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing), independent Ethics Committee

Tipo de dados

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
Further research by GSK Biologicals that is NOT RELATED to influenza vaccine or influenza disease under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic and HIV testing and does not affect subject participation in the study.
Descrição

Use of Biologicals for further research NOT RELATED influenza vaccine/disease (excluding genetics and HIV testing)

Tipo de dados

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
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
Descrição

GSK storage period, informed consent form

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C1698986
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0370003
If other GSK storage period, please specify
Descrição

Other GSK storage period

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1698986
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C0370003
ICF Effective date
Descrição

day month year. Complete and submit a new form for each change during the study

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0009797
Investigator's Signature
Descrição

Investigator's Signature

Alias
UMLS CUI-1
C2346576
Investigator's Signature
Descrição

Investigator's Signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Printed Investigator’s name
Descrição

Printed Investigator’s name

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Date of signature
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Use of human samples by GSK

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Item Group
Use of human samples by GSK
C0022885 (UMLS CUI-1)
C0457083 (UMLS CUI-2)
Quality Assurance of tests
Item
Quality Assurance of tests described in the protocol
boolean
C0178932 (UMLS CUI [1])
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing)
Item
Further investigation by GSK Biologicals into the ability of influenza 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.
boolean
C0457083 (UMLS CUI [1,1])
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])
Use of Biologicals for further influenza vaccine/disease (excluding genetics and HIV testing), independent Ethics Committee
Item
Further investigation by GSK Biologicals into the ability of influenza vaccine to protect people if any findings from related studies require it and further research in influenza disease under study. These investigations excludes genetic and HIV testing. 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
C0457083 (UMLS CUI [1,1])
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])
Use of Biologicals for further research NOT RELATED influenza vaccine/disease (excluding genetics and HIV testing)
Item
Further research by GSK Biologicals that is NOT RELATED to influenza vaccine or influenza disease under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed). This research excludes genetic and HIV testing and does not affect subject participation in the study.
boolean
C0457083 (UMLS CUI [1,1])
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])
Item
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
integer
C1698986 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
GSK storage period, informed consent form
Code List
Please tick if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center.
CL Item
At least 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
Other GSK storage period
Item
If other GSK storage period, please specify
text
C0205394 (UMLS CUI [1,1])
C1698986 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0370003 (UMLS CUI [1,4])
ICF Effective date
Item
ICF Effective date
date
C0011008 (UMLS CUI [1,1])
C0009797 (UMLS CUI [1,2])
Item Group
Investigator's Signature
C2346576 (UMLS CUI-1)
Investigator's Signature
Item
Investigator's Signature
text
C2346576 (UMLS CUI [1])
Printed Investigator’s name
Item
Printed Investigator’s name
text
C2826892 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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