ID

35052

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 Elimination criteria during the study form. It has to be filled in for all workbooks. The elimination criteria should be checked at each visit subsequent to the first visit.

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Keywords

Versions (1)
  1. 2/12/19 2/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 12, 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

English

Elimination criteria during the study

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Elimination criteria during the study
Description

Elimination criteria during the study

Alias
UMLS CUI-1
C0680251
Administration of any other vaccine during the following periods: 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Day 0 up to Day 51; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
Description

Administration of other vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0042210
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Description

chronis is defined as more than 14 days

Data type

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0021081
UMLS CUI [2,1]
C0205191
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0005525
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C0683607
UMLS CUI [4,2]
C2064827
Administration of immunoglobulins and/or any blood products during the study period.
Description

Administration of immunoglobulins and/or any blood products

Data type

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0021027
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0456388
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
Description

Use of other investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0304229
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Similar models

Elimination criteria during the study

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit Day 21 (all WB's)  (1)
CL Item
Visit Day 30 (WB1+2) (2)
CL Item
Visit Day 42 (WB3+4) (3)
CL Item
Visit Day 51 (WB3+4) (4)
CL Item
Visit Month 6 (all WB's)  (5)
CL Item
Visit Month 6+7D (WB1+3) (6)
CL Item
Visit Month 6+21D (WB1+3) (7)
CL Item
Visit Month 6+30D (WB1+)3 (8)
CL Item
Visit Month 12 (all WB's)  (9)
CL Item
Visit Month 12+7D (WB2+4) (10)
CL Item
Visit Month 12+21D (WB2+4) (11)
CL Item
Visit Month 12+30D (WB2+4) (12)
CL Item
Visit Month 18 (all WB's)  (13)
Item Group
Elimination criteria during the study
C0680251 (UMLS CUI-1)
Administration of other vaccine
Item
Administration of any other vaccine during the following periods: 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Day 0 up to Day 51; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0205191 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
C0205191 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0005525 (UMLS CUI [2,3])
C0683607 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C0683607 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Administration of immunoglobulins and/or any blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
Use of other investigational product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
boolean
C1524063 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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