ID

35053

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 Eligibility criteria form. It has to be filled in for screening for each workbook (wb1-4).

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

Eligibility criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility criteria
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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Eligibility check
Description

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If you tick no, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

text

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
Description

Ability to comply study requirements

Data type

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C2348563
A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
Description

Gender, Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Written informed consent obtained from the subject.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Healthy subjects as established by medical history and clinical examination before entering into the study.
Description

Healthy medical status (Medical history, clinial examination)

Data type

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C3898900
UMLS CUI [2,2]
C0031809
If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
Description

Non-childbearing potential/ Use of contraceptive precautions, negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
UMLS CUI [3]
C0427780
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
Description

Administration of licensed vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C0042210
History of vaccination with investigational influenza pandemic vaccine.
Description

Vaccination with investigational influenza pandemic vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1960631
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C1964065
History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E).
Description

Licensed vaccine containing squalene and/or tocopherol

Data type

boolean

Alias
UMLS CUI [1]
C1960631
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0038071
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0332256
UMLS CUI [3,3]
C3255108
Planned administration of a vaccine not foreseen by the study protocol 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.
Description

Planned administration of a vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C1518384
UMLS CUI [1,3]
C1301732
UMLS CUI [1,4]
C0042210
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Description

Chronic administration of immunosuppressants or other immune-modifying drugs

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
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Description

Confirmed or suspected immunosuppressive or immunodeficient condition (medical history, physical examination)

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0021051
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0242114
UMLS CUI [2,3]
C0021051
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0750484
UMLS CUI [3,3]
C0021051
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C0242114
UMLS CUI [4,3]
C0021051
History of hypersensitivity to vaccines.
Description

History of hypersensitivity to vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0042210
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Description

Allergic disease to components of vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1705248
History of chronic alcohol consumption and/or drug abuse.
Description

Chronic alcohol consumption and/or drug abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0001948
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0013146
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Description

Clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality ( physical examination/laboratory screening tests)

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0231921
UMLS CUI [1,4]
C1704258
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0678859
UMLS CUI [2,4]
C1704258
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C2985739
UMLS CUI [3,3]
C0232804
UMLS CUI [3,4]
C1704258
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C2985739
UMLS CUI [4,3]
C0232741
UMLS CUI [4,4]
C1704258
Serious chronic disease. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
Description

including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0683607
UMLS CUI [2,2]
C2106658
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C2826678
UMLS CUI [3,3]
C0004096
Acute disease at the time of enrolment.
Description

Acute disease is defined as the presence of a moderate or severe illness with or without fever (defined as axillary temperature ³37.5°C).

Data type

boolean

Alias
UMLS CUI [1]
C0001314
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
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
Lactating women.
Description

Lactating women

Data type

boolean

Alias
UMLS CUI [1]
C2828358
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Description

Use of/planned use of investigational product

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C1301732
UMLS CUI [2,2]
C1524063
UMLS CUI [2,3]
C0304229
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Description

Contraindications for study participation

Data type

boolean

Alias
UMLS CUI [1,1]
C0522473
UMLS CUI [1,2]
C2348568
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Similar models

Eligibility criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility criteria
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 Group
Eligibility check
C0013893 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Ability to comply study requirements
Item
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
boolean
C0085732 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Gender, Age
Item
A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Informed consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Healthy medical status (Medical history, clinial examination)
Item
Healthy subjects as established by medical history and clinical examination before entering into the study.
boolean
C3898900 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C3898900 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Non-childbearing potential/ Use of contraceptive precautions, negative pregnancy test
Item
If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam) for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
C0427780 (UMLS CUI [3])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Administration of licensed vaccines
Item
Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study.
boolean
C1533734 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccination with investigational influenza pandemic vaccine
Item
History of vaccination with investigational influenza pandemic vaccine.
boolean
C1960631 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1964065 (UMLS CUI [1,3])
Licensed vaccine containing squalene and/or tocopherol
Item
History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E).
boolean
C1960631 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0038071 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C3255108 (UMLS CUI [3,3])
Planned administration of a vaccine
Item
Planned administration of a vaccine not foreseen by the study protocol 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.
boolean
C1533734 (UMLS CUI [1,1])
C1518384 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines. (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])
Confirmed or suspected immunosuppressive or immunodeficient condition (medical history, physical examination)
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0262926 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0021051 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0242114 (UMLS CUI [2,2])
C0021051 (UMLS CUI [2,3])
C0031809 (UMLS CUI [3,1])
C0750484 (UMLS CUI [3,2])
C0021051 (UMLS CUI [3,3])
C0031809 (UMLS CUI [4,1])
C0242114 (UMLS CUI [4,2])
C0021051 (UMLS CUI [4,3])
History of hypersensitivity to vaccines
Item
History of hypersensitivity to vaccines.
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Allergic disease to components of vaccine
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C1527304 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Chronic alcohol consumption and/or drug abuse
Item
History of chronic alcohol consumption and/or drug abuse.
boolean
C0262926 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0013146 (UMLS CUI [2,3])
Clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality ( physical examination/laboratory screening tests)
Item
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
boolean
C0031809 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0231921 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
C0031809 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0678859 (UMLS CUI [2,3])
C1704258 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C0232804 (UMLS CUI [3,3])
C1704258 (UMLS CUI [3,4])
C0031809 (UMLS CUI [4,1])
C2985739 (UMLS CUI [4,2])
C0232741 (UMLS CUI [4,3])
C1704258 (UMLS CUI [4,4])
Serious chronic disease
Item
Serious chronic disease. (Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included).
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0683607 (UMLS CUI [2,1])
C2106658 (UMLS CUI [2,2])
C0683607 (UMLS CUI [3,1])
C2826678 (UMLS CUI [3,2])
C0004096 (UMLS CUI [3,3])
Acute disease
Item
Acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Administration of immunoglobulins and/or any blood products
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the candidate vaccine or during the study.
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
Lactating women
Item
Lactating women.
boolean
C2828358 (UMLS CUI [1])
Use of/planned use of investigational product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1301732 (UMLS CUI [2,1])
C1524063 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
Contraindications for study participation
Item
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
boolean
C0522473 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
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