ID

35019

Beschreibung

Study ID: 107022 Clinical Study ID: 107022 Study Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00321373 Study Link: https://clinicaltrials.gov/ct2/show/NCT00321373 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine GSK1247446A - 2 different formulations Trade Name: FluarixTM Study Indication: Influenza The purpose of his form is to check for the subjects eligibility for the study. Also, to record the randomization of the subject. It should be filled out at visit 1. Visit 1: Day 0, Pre vaccination Visit 2: Day 21, Post vaccination 1 Phone contact: Day 30, post vaccination 1 Visit 3: Day 180, post vaccination 1

Link

https://clinicaltrials.gov/ct2/show/NCT00321373

Stichworte

Versionen (3)
  1. 30.01.19 30.01.19 -
  2. 06.02.19 06.02.19 -
  3. 10.02.19 10.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

10. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Demonstration of the Non-Inferiority of the Low Dose Influenza Vaccine Compared with Fluarix NCT00321373

Englisch

Eligibility Criteria and Randomisation

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility Check
Beschreibung

Eligibility Check

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

If 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.

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
A male or female age 60 years or older at the time of the vaccination.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards).
Beschreibung

Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Written informed consent obtained from the subject.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Beschreibung

No Acute Aggravation of Health Status Established by Clinical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1446390
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C1456356
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Beschreibung

Recent Use of Investigational Product

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0332185
UMLS CUI [2,3]
C0013230
UMLS CUI [3,1]
C0013230
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C1301732
UMLS CUI [4,3]
C0013230
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Beschreibung

Pulmonary, Cardiovascular, Hepatic or Renal Functional Abnormality established by Physical Examination or Laboratory Test

Datentyp

text

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C1704258
UMLS CUI [2,1]
C0678859
UMLS CUI [2,2]
C1704258
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C1704258
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C1704258
UMLS CUI [5,1]
C0443211
UMLS CUI [5,2]
C0031809
UMLS CUI [6,1]
C0443211
UMLS CUI [6,2]
C0438215
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beschreibung

Recent Chronic Administration of Immunosuppressants or Immune-modifying Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332185
UMLS CUI [1,2]
C0021081
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0332185
UMLS CUI [2,2]
C0005525
UMLS CUI [3]
C0582125
UMLS CUI [4,1]
C0332300
UMLS CUI [4,2]
C4050091
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Beschreibung

Confirmed or Suspected Immunodeficient Condition

Datentyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3,1]
C4048329
UMLS CUI [3,2]
C0750491
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5,1]
C0443211
UMLS CUI [5,2]
C0262926
UMLS CUI [6,1]
C0443211
UMLS CUI [6,2]
C0031809
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Beschreibung

Recent Administration of Immunoglobulins or Blood Products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
Beschreibung

Administration of Other Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
History of hypersensivity to a previous dose of influenza vaccine.
Beschreibung

History of Hypersensivity to Influenza Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0262926
Previous vaccination against influenza (2005-2006 influenza vaccine) within the 9 months prior to enrollment.
Beschreibung

Previous Vaccination Against Influenza

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0332185
History of confirmed influenza infection within the last 12 months.
Beschreibung

Recent Influenza Infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021400
UMLS CUI [1,2]
C0332185
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
Beschreibung

History of Allergy to Vaccine Component

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0489531
UMLS CUI [1,2]
C1705248
UMLS CUI [1,3]
C0304229
UMLS CUI [2]
C0013700
UMLS CUI [3]
C0017237
UMLS CUI [4]
C0571339
UMLS CUI [5]
C0017436
UMLS CUI [6]
C0039867
UMLS CUI [7]
C1443000
UMLS CUI [8]
C0037500
Acute disease at the time of enrolment. Axillary temperature <37.5°C (99.5°F)).
Beschreibung

(Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F)

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
Randomisation/Treatment Allocation
Beschreibung

Randomisation/Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record Treatment Number
Beschreibung

Randomisation/Treatment Allocation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0600091
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Ähnliche Modelle

Eligibility Criteria and Randomisation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Entry Criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
A male or female age 60 years or older at the time of the vaccination.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Protocol Compliance
Item
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visit and completion of the diary cards).
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
No Acute Aggravation of Health Status Established by Clinical Examination
Item
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Recent Use of Investigational Product
Item
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0042210 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
Pulmonary, Cardiovascular, Hepatic or Renal Functional Abnormality established by Physical Examination or Laboratory Test
Item
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
text
C0231921 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0678859 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0232741 (UMLS CUI [4,1])
C1704258 (UMLS CUI [4,2])
C0443211 (UMLS CUI [5,1])
C0031809 (UMLS CUI [5,2])
C0443211 (UMLS CUI [6,1])
C0438215 (UMLS CUI [6,2])
Recent Chronic Administration of Immunosuppressants or Immune-modifying Drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0332185 (UMLS CUI [1,1])
C0021081 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0332185 (UMLS CUI [2,1])
C0005525 (UMLS CUI [2,2])
C0582125 (UMLS CUI [3])
C0332300 (UMLS CUI [4,1])
C4050091 (UMLS CUI [4,2])
Confirmed or Suspected Immunodeficient Condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C4048329 (UMLS CUI [3,1])
C0750491 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0443211 (UMLS CUI [5,1])
C0262926 (UMLS CUI [5,2])
C0443211 (UMLS CUI [6,1])
C0031809 (UMLS CUI [6,2])
Recent Administration of Immunoglobulins or Blood Products
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
Administration of Other Vaccines
Item
Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
History of Hypersensivity to Influenza Vaccine
Item
History of hypersensivity to a previous dose of influenza vaccine.
boolean
C0021403 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
Previous Vaccination Against Influenza
Item
Previous vaccination against influenza (2005-2006 influenza vaccine) within the 9 months prior to enrollment.
boolean
C0021403 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Recent Influenza Infection
Item
History of confirmed influenza infection within the last 12 months.
boolean
C0021400 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of Allergy to Vaccine Component
Item
History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg, chicken protein, gelatine, formaldehyde, gentamicin sulphate, thimerosal or sodium deoxycholate.
boolean
C0489531 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0013700 (UMLS CUI [2])
C0017237 (UMLS CUI [3])
C0571339 (UMLS CUI [4])
C0017436 (UMLS CUI [5])
C0039867 (UMLS CUI [6])
C1443000 (UMLS CUI [7])
C0037500 (UMLS CUI [8])
Acute Disease
Item
Acute disease at the time of enrolment. Axillary temperature <37.5°C (99.5°F)).
boolean
C0001314 (UMLS CUI [1])
Item Group
Randomisation/Treatment Allocation
C0034656 (UMLS CUI-1)
Randomisation/Treatment Allocation
Item
Record Treatment Number
integer
C0034656 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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