ID
35862
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 Study conclusion form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Trefwoorden
Versies (2)
- 25-03-19 25-03-19 -
- 29-03-19 29-03-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 maart 2019
DOI
Voor een aanvraag inloggen.
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
Study conclusion
- StudyEvent: ODM
Beschrijving
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
Beschrijving
Serious Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
SAE Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449788
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Elimination criteria
Datatype
text
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Elimination criteria, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1521902
Beschrijving
Withdrawal from study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C0008976
Beschrijving
Withdrawal of subject
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0008976
Beschrijving
If you tick SAE: Please complete and submit SAE report. If you tick AEX: Please complete Non-serious Adverse Event section.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1549995
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0008976
Beschrijving
SAE Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
AE Number/ solicited AE code
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0877248
- UMLS CUI [2,2]
- C0805701
Beschrijving
Protocol violation, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
Other reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C2348235
Beschrijving
Decision taken
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
If you tick No, please give details in Adverse Events section
Datatype
text
Alias
- UMLS CUI [1,1]
- C1142435
- UMLS CUI [1,2]
- C0681850
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
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.
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
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])