ID
35780
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 S ccessive 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 Screening conclusion form. It has to be filled in after the screening visit.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Trefwoorden
Versies (2)
- 22-03-19 22-03-19 -
- 22-03-19 22-03-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 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
Screening conclusion
- StudyEvent: ODM
Beschrijving
Screening conclusion
Alias
- UMLS CUI-1
- C1710477
- UMLS CUI-2
- C1707478
Beschrijving
only SAEs related to study participation or to a concurrent medication need to be considered and reported.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1710477
Beschrijving
SAE Number during screening
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [1,3]
- C1710477
Beschrijving
Was the subject withdrawn prior to randomisation or first vaccination?
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschrijving
(Tick one box only). If you tick ELI: Please tick failing criteria on Eligibility form. If you tick SAE: Please complete and submit SAE report. Please specify SAE No. in the "SAE Number" Item.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschrijving
Specify if you ticked "Protocol violation" or "Other" as major reason for failure.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
Beschrijving
Decision taken for screening failure
Datatype
text
Alias
- UMLS CUI [1,1]
- C1710476
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0679006
Beschrijving
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschrijving
I confirm that I have reviewed the data in these screening forms 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
Screening conclusion
- StudyEvent: ODM
C1710477 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])