ID

42318

Descrizione

Study ID: 108708 Clinical Study ID: 108708 Study Title: A phase IIb, controlled, randomized, multicentre, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 compared to a second dose of FluarixTM (GlaxoSmithKline Biologicals) administered intramuscularly in elderly >= 60 years previously vaccinated in FLU-LD-002 clinical trial Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00385840 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Influenza Vaccine GSK1247446A Trade Name: FluarixTM Study Indication: Influenza

Keywords

versioni (1)
  1. 29/05/21 29/05/21 -
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GlaxoSmithKline

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29 maggio 2021

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Creative Commons BY 4.0
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Immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with AS03 NCT00385840

Inglese

ODM-FormVisit 1, Day 0 Vaccination: Eligibility Check

1 moduli  
Administrative
Descrizione

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Descrizione

Eligibility Check

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

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.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.
Descrizione

A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0042196
UMLS CUI [3,1]
C0021403
UMLS CUI [3,2]
C0445550
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).
Descrizione

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).

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0525058
UMLS CUI [2]
C1522577
Written informed consent obtained from the subject.
Descrizione

Written informed consent obtained from the subject.

Tipo di dati

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.
Descrizione

Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2]
C0541889
UMLS CUI [3]
C1456356
Exclusion Criteria
Descrizione

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.
Descrizione

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.

Tipo di dati

boolean

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

Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C2985739
UMLS CUI [2]
C0231921
UMLS CUI [3]
C1704258
UMLS CUI [4]
C0678859
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0232741
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.)
Descrizione

Immunosuppressive Agents; chronic | Non-Specific Immune-Modulator Therapy | Vaccines | Adrenal Cortex Hormones | prednisone | Inhaled steroids use | Topical form corticosteroids

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0279021
UMLS CUI [3]
C0042210
UMLS CUI [4]
C0001617
UMLS CUI [5]
C0032952
UMLS CUI [6]
C0586793
UMLS CUI [7]
C0304604
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Descrizione

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

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2]
C4048329
UMLS CUI [3]
C0262926
UMLS CUI [4]
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.
Descrizione

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.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0456388
UMLS CUI [3]
C0042196
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.
Descrizione

Vaccines | Enrollment in clinical trial | Study Protocol

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042210
UMLS CUI [2]
C4041024
UMLS CUI [3]
C2348563
History of hypersensivity to a previous dose of influenza vaccine.
Descrizione

History of hypersensivity to a previous dose of influenza vaccine.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0020517
UMLS CUI [2]
C0262926
History of confirmed influenza infection within the last 12 months.
Descrizione

History of confirmed influenza infection within the last 12 months.

Tipo di dati

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.
Descrizione

History of allergies | Component (part); Vaccines | Egg Proteins | gelatin | Allergy to formaldehyde | Gentamicins | thimerosal | Chicken antigen | deoxycholic acid, monosodium salt

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0489531
UMLS CUI [2,1]
C1705248
UMLS CUI [2,2]
C0042210
UMLS CUI [3]
C0013700
UMLS CUI [4]
C0017237
UMLS CUI [5]
C0571339
UMLS CUI [6]
C0017436
UMLS CUI [7]
C0039867
UMLS CUI [8]
C1443000
UMLS CUI [9]
C0037500
Acute disease at the time of enrolment. (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) / Axillary temperature <37.5°C (99.5°F)).
Descrizione

Acute Disease | Enrollment in clinical trial | Illness (finding); Moderate (severity modifier) | Illness (finding); Severe (severity modifier) | Fever | Administration of vaccine | Diarrhea | Upper Respiratory Infections; Mild (qualifier value) | Acute febrile illness; Low Grade | Body Temperature; Oral | Axillary temperature

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001314
UMLS CUI [2]
C4041024
UMLS CUI [3,1]
C0221423
UMLS CUI [3,2]
C0205081
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205082
UMLS CUI [5]
C0015967
UMLS CUI [6]
C2368628
UMLS CUI [7]
C0011991
UMLS CUI [8,1]
C0041912
UMLS CUI [8,2]
C2945599
UMLS CUI [9,1]
C0743842
UMLS CUI [9,2]
C1282907
UMLS CUI [10,1]
C0005903
UMLS CUI [10,2]
C0442027
UMLS CUI [11]
C1531924
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Similar models

ODM-FormVisit 1, Day 0 Vaccination: Eligibility Check

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.
Item
A male or female age 60 years or older at the time of the revaccination, who previously received either the low dose adjuvanted (AS03) influenza vaccine or Fluarix during the FLU- LD-002; FLU-LD-006 EXT-002 (D180) clinical trial.
boolean
C0001779 (UMLS CUI [1])
C0042196 (UMLS CUI [2])
C0021403 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
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).
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
C0085732 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
C1522577 (UMLS CUI [2])
Written informed consent obtained from the subject.
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Item
Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
boolean
C0018759 (UMLS CUI [1])
C0541889 (UMLS CUI [2])
C1456356 (UMLS CUI [3])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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.
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])
C1301732 (UMLS CUI [3])
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or 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 [2])
C1704258 (UMLS CUI [3])
C0678859 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
Immunosuppressive Agents; chronic | Non-Specific Immune-Modulator Therapy | Vaccines | Adrenal Cortex Hormones | prednisone | Inhaled steroids use | Topical form corticosteroids
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
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0279021 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
C0001617 (UMLS CUI [4])
C0032952 (UMLS CUI [5])
C0586793 (UMLS CUI [6])
C0304604 (UMLS CUI [7])
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1])
C4048329 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
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.
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])
C0456388 (UMLS CUI [2])
C0042196 (UMLS CUI [3])
Vaccines | Enrollment in clinical trial | Study Protocol
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])
C4041024 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
History of hypersensivity to a previous dose of 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 [2])
History of confirmed influenza infection within the last 12 months.
Item
History of confirmed influenza infection within the last 12 months.
boolean
C0021400 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of allergies | Component (part); Vaccines | Egg Proteins | gelatin | Allergy to formaldehyde | Gentamicins | thimerosal | Chicken antigen | deoxycholic acid, monosodium salt
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])
C1705248 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
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 (UMLS CUI [9])
Acute Disease | Enrollment in clinical trial | Illness (finding); Moderate (severity modifier) | Illness (finding); Severe (severity modifier) | Fever | Administration of vaccine | Diarrhea | Upper Respiratory Infections; Mild (qualifier value) | Acute febrile illness; Low Grade | Body Temperature; Oral | Axillary temperature
Item
Acute disease at the time of enrolment. (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) / Axillary temperature <37.5°C (99.5°F)).
boolean
C0001314 (UMLS CUI [1])
C4041024 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C0221423 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0015967 (UMLS CUI [5])
C2368628 (UMLS CUI [6])
C0011991 (UMLS CUI [7])
C0041912 (UMLS CUI [8,1])
C2945599 (UMLS CUI [8,2])
C0743842 (UMLS CUI [9,1])
C1282907 (UMLS CUI [9,2])
C0005903 (UMLS CUI [10,1])
C0442027 (UMLS CUI [10,2])
C1531924 (UMLS CUI [11])
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