Informações:
Falhas:
ID
36322
Descrição
Study ID: 111258 Clinical Study ID: 111258 Study Title: A phase IV, observer-blind, randomized single-dose post-marketing study to compare the safety and immunogenicity of Fluviral Trivalent Split Virion Influenza Vaccine (2007 - 2008 Season) made with new vs. aged bulk material, in adults ranging in age from 18 to 60 Years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00586469 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Influenza Vaccine Trade Name: Fluviral Study Indication: Influenza
Palavras-chave
Versões (1)
- 03/05/2019 03/05/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
3 de maio de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469
Similar models
Visit 1 - Day 0
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Elimination Criteria During the Study
C0680251 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013227 (UMLS CUI [1])
Immunosuppressive Agents, Chronic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune- modifying 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
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,2])
Immunoglobulins, Blood Product
Item
Administration of immunoglobulins and/or any blood products during the study.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Vaccination, Concomitant Agent,
Item
Administration of any vaccine other than the study vaccine during the study.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Vaccination, Concomitant Agent
Item
Administration of any vaccine other than the study vaccine during the study.
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the Fluviral vaccine or Influenza disease under study? (only for the subset group)
text
C0013227 (UMLS CUI [1,1])
C0457083 (UMLS CUI [1,2])
C0457083 (UMLS CUI [1,2])
Code List
Did the subject agree that her/his biological samples(s) may be used by GSK Biologicals for further research that is NOT RELATED to the Fluviral vaccine or Influenza disease under study? (only for the subset group)
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (1)
CL Item
Female (2)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other, specify (10)
Body Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Protocol Compliance
Item
Subjects who the investigator believes 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
C0525058 (UMLS CUI [1])
Gender, Age
Item
Male and female adults, 18 to 60 years.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
Informed Consent
Item
Written informed consent obtained from the subject.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential, Absent; Contraceptive methods
Item
If the subject is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study. Adequate methods of contraceptives include: - Barrier method plus spermicide; - Oral or implanted contraceptive use (at 30 days prior to study enrollment); - Intra-uterine device (at least 30 days to study enrollment); - Depot injection of a progestogen drug (e.g., Depo-Provera®) (starting at least 30 days prior to study enrollment); - History of abstinence - Adequate contraception is further defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent). For azoospermia, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age, e.g., > 45 years.
boolean
C3831118 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
C0332197 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2])
Acute Disease
Item
Acute disease at the time of enrollment. (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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C / Axillary temperature <37.5°C).
boolean
C0001314 (UMLS CUI [1])
Immunologic Deficiency Syndromes
Item
Any confirmed or suspected immunosuppressive condition including: -History of human immunodeficiency virus (HIV) infection, -Cancer or treatment for cancer, within 3 years of study enrollment. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
boolean
C0021051 (UMLS CUI [1])
Hematological Disease
Item
Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
boolean
C0018939 (UMLS CUI [1])
Immunosuppressive Agents
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six 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])
Demyelinating Diseases
Item
A history of any demyelinating disease including Guillain-Barré syndrome.
boolean
C0011303 (UMLS CUI [1])
nervous system disorder
Item
Presence of an active neurological disorder.
boolean
C0027765 (UMLS CUI [1])
Blood Coagulation Disorders
Item
Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency are eligible.
boolean
C0005779 (UMLS CUI [1])
Influenza virus vaccine
Item
Receipt of an influenza vaccine within 6 months prior to study enrollment.
boolean
C0021403 (UMLS CUI [1])
Vaccination, Clinical Trials
Item
Administration of any vaccines within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the Safety Set, but excluded from the Per Protocol Set.
boolean
C0042196 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,2])
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
boolean
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
boolean
C0013227 (UMLS CUI [1])
Immunoglobulins, Blood product
Item
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
C0456388 (UMLS CUI [1,2])
Experimental drug, Hypersensitivity; Egg Food Product, Hypersensitivity; Mercury Compounds, Hypersensitivity
Item
Any known or suspected allergy to any constituent of Fluviral (egg protein, thimerosal) and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury (such as thimerosal).
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0013710 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C3536917 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
C0020517 (UMLS CUI [1,2])
C0013710 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C3536917 (UMLS CUI [3,1])
C0020517 (UMLS CUI [3,2])
Influenza virus vaccine, Serious Adverse Event
Item
A history of severe adverse reaction to a previous influenza vaccination.
boolean
C0021403 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
Breast Feeding
Item
Lactating/nursing female.
boolean
C0006147 (UMLS CUI [1])
Study Subject Participation Status, Inappropriate
Item
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,2])
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
C0031809 (UMLS CUI-2)
Disease; Symptoms
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
boolean
C0012634 (UMLS CUI [1])
C1457887 (UMLS CUI [2])
C1457887 (UMLS CUI [2])
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (incl allergies, autoimmune disorders) (15)
CL Item
Infections and infestations (16)
CL Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps) (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (19)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Past or Current?
text
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
C1444637 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,3])
CL Item
Past (1)
CL Item
Current (2)
Item Group
Laboratory Tests - Blood Sample
C0005834 (UMLS CUI-1)
Item
Has a blood sample been taken for serology?
text
C0005834 (UMLS CUI [1])
Code List
Has a blood sample been taken for serology?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Collection of blood specimen for laboratory procedure, Date in time
Item
Date if different from visit date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (Not of childbearing potential or male.) (3)
Urine pregnancy test, Date in time
Item
Date if different from visit date
date
C0430056 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
History of Influenza Vaccination
C0021403 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C0205156 (UMLS CUI-2)
Item Group
History of Influenza Vaccination
C0021403 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
C0205156 (UMLS CUI-2)
Influenza virus vaccine, Previous
Item
Has the subject been vaccinated against influenza in the past?
boolean
C0021403 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
Item
If Yes, specify
text
C0021403 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,2])
CL Item
Season 2006 – 2007 (1)
CL Item
Season 2005 – 2006 (2)
CL Item
Season 2004 – 2005 (3)
CL Item
Season prior to 2004 (4)
Item Group
Vaccine Administration
C0021403 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C2368628 (UMLS CUI-2)
Influenza virus vaccine, Administration of Vaccine, Date in time
Item
Date if different from visit date
date
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Influenza virus vaccine, Body Temperature, Vaccination, Before
Item
Pre-Vaccination temperature
float
C0021403 (UMLS CUI [1,1])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0005903 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
Item
Route
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
CL Item
Axillary (1)
CL Item
Oral (protocol case - using an oral digital thermometer) (2)
CL Item
Rectal (3)
Item
Vaccine Administration (only one box must be ticked by vaccine)
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,2])
Code List
Vaccine Administration (only one box must be ticked by vaccine)
CL Item
Study Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Not administered (3)
Item
If Replacement vial, give number
integer
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
C2368628 (UMLS CUI [1,2])
C0184301 (UMLS CUI [1,3])
C0559956 (UMLS CUI [1,4])
C0600091 (UMLS CUI [1,5])
Item
Side / Site, Route
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C0013153 (UMLS CUI [1,4])
Code List
Side / Site, Route
CL Item
Non dominant, Deltoid, I.M. (Non dominant, Deltoid, I.M.)
Influenza virus vaccine, Administration of Vaccine, Protocol Compliance
Item
Has the study vaccine been administered according to the Protocol?
boolean
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Item
If No, Side
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
CL Item
Dominant (1)
CL Item
Non dominant (2)
Item
If No, Site
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,3])
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
If No, Route
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
CL Item
I.M. (1)
CL Item
S.C (2)
Item
Why not administered? Please tick the major reason for non administration.
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Code List
Why not administered? Please tick the major reason for non administration.
CL Item
Serious adverse event (Please specify SAE No.) (1)
CL Item
Non-Serious adverse event. (Please specify AE No.) (2)
CL Item
Other, please specify (3)
Item
Please tick who made the decision
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
C2368628 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,3])
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Subject (2)