ID
35862
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 Study conclusion form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Keywords
Versions (2)
- 3/25/19 3/25/19 -
- 3/29/19 3/29/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
March 29, 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
Study conclusion
- StudyEvent: ODM
Description
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
Description
Serious Adverse Event
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
SAE Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Description
Elimination criteria
Data type
text
Alias
- UMLS CUI [1]
- C0680251
Description
Elimination criteria, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Description
Withdrawal from study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C0008976
Description
Withdrawal of subject
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Description
If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.
Data type
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Description
SAE Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
AE Number/ solicited AE code
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Description
Protocol violation, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Description
Other reason, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Description
Decision taken
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
If you tick No, please give details in Adverse Events section
Data type
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
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
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])