ID

36322

Description

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

Keywords

Versions (1)
  1. 5/3/19 5/3/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 3, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Fluvial Trivalent Split Vision Influenza Vaccine; NCT00586469

English

Visit 1 - Day 0

1 forms  
  1. StudyEvent: ODM
    1. Visit 1 - Day 0
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Description

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
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.)
Description

Immunosuppressive Agents, Chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
Administration of immunoglobulins and/or any blood products during the study.
Description

Immunoglobulins, Blood Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Administration of any vaccine other than the study vaccine during the study.
Description

Vaccination, Concomitant Agent,

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Administration of any vaccine other than the study vaccine during the study.
Description

Vaccination, Concomitant Agent

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
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)
Description

Pharmaceutical Preparations, Usage

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0457083
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Institution name, Identifier

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of Birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnic group

Data type

text

Alias
UMLS CUI [1]
C0015031
Race
Description

Racial group

Data type

text

Alias
UMLS CUI [1]
C0034510
Height
Description

Body Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Body Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Eligibility Check
Description

Eligibility Check

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

Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
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.
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Male and female adults, 18 to 60 years.
Description

Gender, Age

Data type

boolean

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

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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.
Description

Childbearing Potential, Absent; Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
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).
Description

Acute Disease

Data type

boolean

Alias
UMLS CUI [1]
C0001314
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.
Description

Immunologic Deficiency Syndromes

Data type

boolean

Alias
UMLS CUI [1]
C0021051
Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
Description

Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018939
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.)
Description

Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1]
C0021081
A history of any demyelinating disease including Guillain-Barré syndrome.
Description

Demyelinating Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0011303
Presence of an active neurological disorder.
Description

nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0027765
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.
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
Receipt of an influenza vaccine within 6 months prior to study enrollment.
Description

Influenza virus vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0021403
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.
Description

Vaccination, Clinical Trials

Data type

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0008976
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.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
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.
Description

Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1]
C0013227
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
Description

Immunoglobulins, Blood product

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
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).
Description

Experimental drug, Hypersensitivity; Egg Food Product, Hypersensitivity; Mercury Compounds, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
UMLS CUI [2,1]
C0013710
UMLS CUI [2,2]
C0020517
UMLS CUI [3,1]
C3536917
UMLS CUI [3,2]
C0020517
A history of severe adverse reaction to a previous influenza vaccination.
Description

Influenza virus vaccine, Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C1519255
Lactating/nursing female.
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Description

Study Subject Participation Status, Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
Randomisation / Treatment Allocation
Description

Randomisation / Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Randomization, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
General Medical History / Physical Examination
Description

General Medical History / Physical Examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

Disease; Symptoms

Data type

boolean

Alias
UMLS CUI [1]
C0012634
UMLS CUI [2]
C1457887
MedDRA System Organ Class
Description

MedDRA System Organ Class

Data type

text

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Past or Current?
Description

Diagnosis, Past, Current

Data type

text

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
UMLS CUI [1,3]
C0521116
Laboratory Tests - Blood Sample
Description

Laboratory Tests - Blood Sample

Alias
UMLS CUI-1
C0005834
Has a blood sample been taken for serology?
Description

Collection of blood specimen for laboratory procedure

Data type

text

Alias
UMLS CUI [1]
C0005834
Date if different from visit date
Description

Collection of blood specimen for laboratory procedure, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
HCG Urine Pregnancy Test
Description

HCG Urine Pregnancy Test

Alias
UMLS CUI-1
C0430056
Has a urine sample been taken?
Description

Urine pregnancy test

Data type

text

Alias
UMLS CUI [1]
C0430056
Date if different from visit date
Description

Urine pregnancy test, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0011008
Result
Description

Urine pregnancy test, Result

Data type

text

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C1274040
History of Influenza Vaccination
Description

History of Influenza Vaccination

Alias
UMLS CUI-1
C0021403
UMLS CUI-2
C0205156
History of Influenza Vaccination
Description

History of Influenza Vaccination

Alias
UMLS CUI-1
C0021403
UMLS CUI-2
C0205156
Has the subject been vaccinated against influenza in the past?
Description

Influenza virus vaccine, Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0205156
If Yes, specify
Description

Influenza virus vaccine, Previous

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0205156
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C0021403
UMLS CUI-2
C2368628
Date if different from visit date
Description

Influenza virus vaccine, Administration of Vaccine, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0011008
Pre-Vaccination temperature
Description

Influenza virus vaccine, Body Temperature, Vaccination, Before

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0005903
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0332152
°C
Route
Description

Influenza virus vaccine, Administration of vaccine, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0013153
Vaccine Administration (only one box must be ticked by vaccine)
Description

Influenza virus vaccine, Administration of Vaccine

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
If Replacement vial, give number
Description

Influenza virus vaccine, Administration of Vaccine, Vial Device, Replacement, Numbers

Data type

integer

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0184301
UMLS CUI [1,4]
C0559956
UMLS CUI [1,5]
C0600091
Side / Site, Route
Description

Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
UMLS CUI [1,4]
C0013153
Has the study vaccine been administered according to the Protocol?
Description

Influenza virus vaccine, Administration of Vaccine, Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0525058
If No, Side
Description

Influenza virus vaccine, Administration of Vaccine, Side

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0441987
If No, Site
Description

Influenza virus vaccine, Administration of Vaccine, Anatomic site

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1515974
If No, Route
Description

Influenza virus vaccine, Administration of Vaccine, Drug Administration Routes

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0013153
Why not administered? Please tick the major reason for non administration.
Description

Influenza virus vaccine, Administration of Vaccine, Not done

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
Please tick who made the decision
Description

Influenza virus vaccine, Administration of Vaccine, Decision

Data type

text

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0679006
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Visit 1 - Day 0

1 forms
  1. StudyEvent: ODM
    1. Visit 1 - Day 0
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
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)
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])
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])
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])
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])
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
Informed Consent, Date in time
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
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])
Pharmaceutical Preparations, Usage
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)
Item Group
Demographics
C1704791 (UMLS CUI-1)
Institution name, Identifier
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
undefined item
Code List
Gender
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity
text
C0015031 (UMLS CUI [1])
Ethnic group
Code List
Ethnicity
CL Item
American Hispanic or Latino  (1)
CL Item
Not American Hispanic or Latino (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Racial group
Code List
Race
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])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Determination
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (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])
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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
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])
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])
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])
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])
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])
Item Group
Randomisation / Treatment Allocation
C0034656 (UMLS CUI-1)
Randomization, Numbers
Item
Record treatment number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
General Medical History / Physical Examination
C0262926 (UMLS CUI-1)
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])
Item
MedDRA System Organ Class
text
C2347091 (UMLS CUI [1])
MedDRA System Organ Class
Code List
MedDRA System Organ Class
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])
Diagnosis, Past, Current
Code List
Past or Current?
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])
Collection of blood specimen for laboratory procedure
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])
Item Group
HCG Urine Pregnancy Test
C0430056 (UMLS CUI-1)
Item
Has a urine sample been taken?
text
C0430056 (UMLS CUI [1])
Urine pregnancy test
Code List
Has a urine sample been taken?
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])
Item
Result
text
C0430056 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Urine pregnancy test, Result
Code List
Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
History of Influenza Vaccination
C0021403 (UMLS CUI-1)
C0205156 (UMLS CUI-2)
Item Group
History of Influenza Vaccination
C0021403 (UMLS CUI-1)
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])
Item
If Yes, specify
text
C0021403 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Influenza virus vaccine, Previous
Code List
If Yes, specify
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)
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])
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])
Item
Route
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of vaccine, Drug Administration Routes
Code List
Route
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])
Influenza virus vaccine, Administration of Vaccine
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])
Influenza virus vaccine, Administration of Vaccine
Code List
If Replacement vial, give number
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])
Influenza virus vaccine, Administration of Vaccine, Anatomic Site, Drug Administration Routes
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])
Item
If No, Side
text
C0021403 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0441987 (UMLS CUI [1,3])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Side
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])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Site
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])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
If No, Route
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])
Influenza virus vaccine, Administration of Vaccine, Side
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])
Influenza virus vaccine, Administration of Vaccine, Side
Code List
Please tick who made the decision
CL Item
Investigator (1)
CL Item
Subject (2)
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