ID
35158
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 Vaccine administration form. It has to be filled in for screening for all workbooks (WB1-4). It also has to be filled in for: WB 1: Visit Month 6 WB 2: Visit Month 12 WB 3: Visit Day 21 and Visit Month 6 WB 4: Visit Day 21 and Visit Month 12
Link
https://clinicaltrials.gov/ct2/show/NCT00430521
Keywords
Versions (2)
- 2/18/19 2/18/19 -
- 2/20/19 2/20/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
February 20, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521
Vaccine administration
- StudyEvent: ODM
Description
Vaccine administration
Alias
- UMLS CUI-1
- C2368628
Description
day month year (fill in only if different from visit date)
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C2368628
Description
Pre-Vaccination temperature
Data type
float
Measurement units
- °C
Alias
- UMLS CUI [1,1]
- C0005903
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C0042196
Description
Route of temperature measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C0886414
- UMLS CUI [1,2]
- C0449444
Description
(only one box must be ticked by vaccine). If you tick Not administered, please complete "Reason for non administration" in the following itemgroup.
Data type
text
Alias
- UMLS CUI [1]
- C2368628
Description
Replacement vial number
Data type
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C0559956
- UMLS CUI [1,3]
- C0600091
Description
Wrong vial number
Data type
text
Alias
- UMLS CUI [1,1]
- C0184301
- UMLS CUI [1,2]
- C3827420
- UMLS CUI [1,3]
- C0600091
Description
Admnistration according to protocol: Deltoid, non dominant (arm), I.M. If you tick "No", please fill in all Items that apply in the following.
Data type
text
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C2348563
Description
Fill in only if study vaccine has been not administered according to the protocol.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C0441987
Description
Fill in only if study vaccine has been not administered according to the protocol.
Data type
integer
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0042196
Description
Fill in only if study vaccine has been not administered according to the protocol.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042196
Description
Reason for non administration
Alias
- UMLS CUI-1
- C1533734
- UMLS CUI-2
- C0392360
- UMLS CUI-3
- C1272696
Description
If you tick SAE please complete and submit SAE report. If you tick Non-serious AE please complete Non-Serious Adverse Event section.
Data type
text
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C1272696
Description
Fill in this item if you ticked SAE as reason for non administration
Data type
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
Description
Fill in this item if you ticked Non-serious AE as reason for non administration
Data type
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Description
Solicited AE Number
Data type
text
Alias
- UMLS CUI [1,1]
- C1517001
- UMLS CUI [1,2]
- C1518404
- UMLS CUI [1,3]
- C0237753
Description
(e.g.: consent withdrawal, Protocol violation, …)
Data type
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1533734
- UMLS CUI [1,3]
- C1272696
Description
Decision maker
Data type
text
Alias
- UMLS CUI [1]
- C0679006
Similar models
Vaccine administration
- StudyEvent: ODM
C2368628 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0449444 (UMLS CUI [1,2])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0392360 (UMLS CUI-2)
C1272696 (UMLS CUI-3)
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1533734 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])