ID
35057
Description
Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the Laboratory test (for humoral immune response) form. It has to be filled in for all study vists (except telephone contact visits) for all workbooks (wb1-4)
Link
https://clinicaltrials.gov/ct2/show/NCT00430521
Keywords
Versions (2)
- 2/12/19 2/12/19 -
- 2/20/19 2/20/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 12, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521
Laboratory test (for humoral immune response)
- StudyEvent: ODM
Description
Laboratory test (humoral immune respons)
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0020967
Description
Blood sample for humoral immune response
Data type
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0020967
- UMLS CUI [1,3]
- C0521982
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0005834
- UMLS CUI [1,3]
- C0020967
- UMLS CUI [1,4]
- C0521982
Similar models
Laboratory test (for humoral immune response)
- StudyEvent: ODM
C0020967 (UMLS CUI-2)
C0020967 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
C0005834 (UMLS CUI [1,2])
C0020967 (UMLS CUI [1,3])
C0521982 (UMLS CUI [1,4])