ID
35162
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 Concomitant Vaccination form. It has to be filled in for all Visits/contacts (except screening) for each workbook. Any vaccine not foreseen in the study protocol administered in the period beginning 2 weeks (for inactivated vaccines)or 4 weeks (for live vaccines) preceding each dose of study vaccine and during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days is to be recorded with trade name, route of administration and date(s) of administration. Any influenza vaccine other than the candidate vaccines administered during the study period is to be recorded with trade name, route of administration and date(s) of administration.
Link
https://clinicaltrials.gov/ct2/show/NCT00430521
Keywords
Versions (2)
- 2/18/19 2/18/19 -
- 2/20/19 2/20/19 -
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
Concomitant Vaccination
- StudyEvent: ODM
Description
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C1317250
Description
If you tick "yes" please fill in following items. At each study visit/contact, the investigator should question the subject about any vaccination(s) administered.
Data type
text
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C1444655
- UMLS CUI [1,3]
- C2348563
Description
Trade/ (Generic) Name
Data type
text
Alias
- UMLS CUI [1,1]
- C0027365
- UMLS CUI [1,2]
- C0042210
Description
Route of administration
Data type
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Description
For GSK
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])