ID
35115
Beschreibung
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
Stichworte
Versionen (2)
- 18.02.19 18.02.19 -
- 20.09.21 20.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. Februar 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521
Demography, informed consent, randomisation/ treatment allocation
Beschreibung
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beschreibung
Randomisation/ Treatment Allocation
Alias
- UMLS CUI-1
- C1522541
Beschreibung
Demography
Alias
- UMLS CUI-1
- C0011298
Beschreibung
Center number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Sex
Datentyp
text
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
Race
Alias
- UMLS CUI-1
- C0034510
Beschreibung
A person having origins in any of the black racial groups of Africa
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschreibung
A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschreibung
A person having origins in China, Korea
Datentyp
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschreibung
A person having origins in Japan
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschreibung
A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschreibung
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
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschreibung
A person having origins in any of the original peoples of Middle East or North Africa
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Beschreibung
A person having origins in any of the original peoples of Europe
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0043157
Beschreibung
Other racial group
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other racial group, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
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Demography, informed consent, randomisation/ treatment allocation
C0011008 (UMLS CUI [1,2])
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C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
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C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])