ID
35862
Beskrivning
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 Study conclusion form. It has to be filled in for the end of study.
Länk
https://clinicaltrials.gov/ct2/show/NCT00510874
Nyckelord
Versioner (2)
- 2019-03-25 2019-03-25 -
- 2019-03-29 2019-03-29 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
29 mars 2019
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Study conclusion
- StudyEvent: ODM
Beskrivning
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
Beskrivning
Serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
SAE Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beskrivning
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
Elimination criteria
Datatyp
text
Alias
- UMLS CUI [1]
- C0680251
Beskrivning
Elimination criteria, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beskrivning
Withdrawal from study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C0008976
Beskrivning
Withdrawal of subject
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Beskrivning
If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Beskrivning
SAE Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beskrivning
AE Number/ solicited AE code
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Beskrivning
Protocol violation, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beskrivning
Other reason, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beskrivning
Decision taken
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C0805839
Beskrivning
If you tick No, please give details in Adverse Events section
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Printed Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study conclusion
- StudyEvent: ODM
C0449788 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
C2348235 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0681850 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])