ID
35115
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 demography, informed consent and randomisation/ treatment allocation form. It has to be filled in for screening for all workbooks (WB1-4).
Link
https://clinicaltrials.gov/ct2/show/NCT00430521
Keywords
Versions (2)
- 2/18/19 2/18/19 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 18, 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
Demography, informed consent, randomisation/ treatment allocation
Description
Informed consent
Alias
- UMLS CUI-1
- C0021430
Description
Randomisation/ Treatment Allocation
Alias
- UMLS CUI-1
- C1522541
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Center number
Data type
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
Race
Alias
- UMLS CUI-1
- C0034510
Description
A person having origins in any of the black racial groups of Africa
Data type
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment
Data type
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)
Data type
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
A person having origins in China, Korea
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
A person having origins in Japan
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia
Data type
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
A person having origins in any of the original peoples of Middle East or North Africa
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Description
A person having origins in any of the original peoples of Europe
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Description
Other racial group
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Description
Other racial group, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Similar models
Demography, informed consent, randomisation/ treatment allocation
C0011008 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
(Comment:en)
(Comment:en)
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])