ID
35159
Beschrijving
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 Study conclusion/Core analysis conclusion form. For all WB's it has to be filled in for the end of study. Additionally it has to be filled in for: 1 = Core Analysis 1 Month 6 (WB2+4) 2 = Core Anaylsis 1 Month 6 + 30 days (WB1+3) 3 = Core Analysis 2 Month 12 (WB1+3) 4 = Core Analysis 2 Month 12 + 30 days (WB2+4)
Link
https://clinicaltrials.gov/ct2/show/NCT00430521
Trefwoorden
Versies (1)
- 20-02-19 20-02-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 februari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521
Study/Core analysis conclusion
- StudyEvent: ODM
Beschrijving
Occurrence of serious adverse event
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2745955
Beschrijving
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
Datatype
text
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C1519255
Beschrijving
Number of SAE
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
If you tick yes, complete the pregnancy notification form. Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
Datatype
text
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0008976
Beschrijving
Elimination criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18
Datatype
text
Alias
- UMLS CUI [1]
- C0680251
Beschrijving
Elimination criteria, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C2348235
Beschrijving
Withdraw from study
Alias
- UMLS CUI-1
- C2349954
- UMLS CUI-2
- C0008976
Beschrijving
Time specification: For WB1+3: 1) between Visit Day 0 and Telephone Contact Month 6 + 30 days, 2) between Telephone Contact Month 6 + 30 days and Visit Month 12, 3) between Visit Month 12 and Visit Month 18 For WB2+4: 1) between Visit Day 0 and Visit Month 6, 2) between Visit Month 6 and Telephone contact Month 12 + 30 days, 3) between Telephone contact Month 12 + 30 days and Visit Month 18 "A subject is withdrawn from the CORE analysis 1/2 if he/she did not come for the CORE analysis 1/2 timepoint visit."
Datatype
text
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
(tick one box only). 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]
- C2349954
- UMLS CUI [1,2]
- C0566251
Beschrijving
Fill in if you ticked SAE as reason for withdrawal.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Beschrijving
Fill in if you ticked AE as reason for withdrawal.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Fill in if you ticked AE as reason for withdrawal.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C1517001
- UMLS CUI [1,3]
- C0805701
Beschrijving
Fill in if you ticked Protocol violation as reason for withdrawal.
Datatype
text
Alias
- UMLS CUI [1,1]
- C1709750
- UMLS CUI [1,2]
- C2348235
Beschrijving
Fill in if you ticked other as reason for withdrawal.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beschrijving
Decision maker
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]
- C0332158
- UMLS CUI [1,2]
- C0681850
- UMLS CUI [1,3]
- C1142435
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/Core analysis conclusion
- StudyEvent: ODM
C2745955 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,2])
C1142435 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])