ID

45926

Beschreibung

Principal Investigator: Robert Couch, MD, Baylor College of Medicine, Houston, Texas, USA MeSH: Influenza, Human https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001030 The overall purpose of this study is to investigate the host genetic factors in response to influenza virus infection, with the focus on influenza vaccination in the first substudy "Adult Influenza Vaccine Genetics" and with the focus on influenza natural infection and other acute respiratory infections (ARIs) in the second substudy "Acute Viral Respiratory Infection Genetics". In the first substudy, healthy adults were enrolled in 2008 (male cohort) and 2010 (female cohort) and immunized with seasonal influenza vaccine. In the second substudy, healthy adults were invited to enroll to be followed for acute respiratory illness through two consecutive influenza seasons 2009-2010 and 2010-2011. Peripheral blood genomic DNA samples were collected from all the subjects, and time-series RNA and serum samples were obtained pre- and post- immunization/infection. Genotyping was carried out on peripheral blood genomic DNA samples using Illumina HumanOmniExpress-12 v1 arrays. Peripheral blood RNA samples obtained at each visit were analyzed using Illumina Human HT-12 (for all the samples) and HiSeq 2000 (for 130 samples in the "Acute Viral Respiratory Infection Genetics" study). Serum specimens were tested using hemagglutination-inhibition (HAI) antibody assay for Influenza H1N1, H3N2, and Influenza B strains. A detailed description of each substudy is provided under their own pages below and via the grouping tool in the right-hand box:- phs000635 Adult Influenza Vaccine Genetics - phs001031 Acute Viral Respiratory Infection Genetics

Link

dbGaP study = phs001030

Stichworte

Versionen (1)
  1. 27-02-24 27-02-24 - Simon Heim
Rechteinhaber

Robert Couch, MD, Baylor College of Medicine, Houston, Texas, USA

Hochgeladen am

27 februari 2024

DOI

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Lizenz

Creative Commons BY 4.0
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dbGaP phs001030 Viral Respiratory Pathogens Genetics

Englisch

Eligibility Criteria

9 Formulare  
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. This subject consent data table contains subject IDs, consent group information, subject aliases, and affection status (all subjects are controls).
    3. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes the study/substudy (phs accession) that the sample belongs to and sample use.
    4. This subject phenotype data table includes subject sex, race, age, year of enrollment, log2 antibody titers (n=18 variables; Assays: hemagglutination inhibition and neutralization; Antigens: H1N1, H3N2, FluB; Time: preimmune, 14 days, and 28 days).
    5. This sample attributes data table includes body site where sample was collected, analyte type, and genotyping center.
    6. This sample GEO mapping data table includes a mapping of sample IDs to GEO accession IDs, and RNA IDs collected at each study visit.
    7. This subject phenotype data table includes subject sex, age, year of enrollment, receipt of seasonal influenza vaccine (n=3; 2008-2010), recipet of 2009 pH1N1 swine influenza vaccine, virus detected in nasal wash, antiviral drug taken by subjects, maximum oral temperature on first day of illness, duration of symptoms, and log2 antibody titers (n=4 variables; hemagglutination inhibition assay; Time: baseline, acute infection, convalescent, and spring).
    8. This sample attributes data table includes body site where sample was collected, analyte type, genotyping and sequencing centers, and sample collection date.
    9. This subject GEO mapping data table includes a mapping of subject IDs to GEO accession IDs, and RNA IDs collected different time points.
Inclusion and exclusion criteria
Beschreibung

Inclusion and exclusion criteria

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
*Inclusion Criteria:*
Beschreibung

*Inclusion Criteria:*

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1512693
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
Beschreibung

For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C0314603
UMLS CUI [1,3]
C0001675
UMLS CUI [1,4]
C0339901
UMLS CUI [1,5]
C0521026
Adults age 18 to 49 at Texas A&M University and in the community.
Beschreibung

Adults age 18 to 49 at Texas A&M University and in the community.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0001779
In good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
Beschreibung

In good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1277245
UMLS CUI [1,2]
C0518766
UMLS CUI [1,3]
C0018810
UMLS CUI [1,4]
C0005823
UMLS CUI [1,5]
C1532216
UMLS CUI [1,6]
C0262926
UMLS CUI [1,7]
C0031809
Able to understand and comply with planned study procedures.
Beschreibung

Able to understand and comply with planned study procedures.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0525058
Provides informed consent prior to any study procedures and is available for all study visits.
Beschreibung

Provides informed consent prior to any study procedures and is available for all study visits.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C1512346
Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine device, and/or a licensed hormonal method) for the study period.
Beschreibung

Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine device, and/or a licensed hormonal method) for the study period.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4324275
UMLS CUI [1,2]
C0680240
UMLS CUI [1,3]
C4546343
UMLS CUI [1,4]
C0205411
UMLS CUI [1,5]
C0004764
UMLS CUI [1,6]
C0036899
UMLS CUI [1,7]
C0021900
UMLS CUI [1,8]
C5768052
UMLS CUI [1,9]
C1948053
For "Acute Viral Respiratory Infection Genetics" only: Able to report to the study site within 48 hours of onset with a moderate or severe ARI (with fever or that causes them to miss school, work, or social activities) during the surveillance period.
Beschreibung

For "Acute Viral Respiratory Infection Genetics" only: Able to report to the study site within 48 hours of onset with a moderate or severe ARI (with fever or that causes them to miss school, work, or social activities) during the surveillance period.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0729531
UMLS CUI [1,2]
C0314603
UMLS CUI [2,1]
C1299581
UMLS CUI [2,2]
C2825164
UMLS CUI [2,3]
C0332168
UMLS CUI [2,4]
C0332162
UMLS CUI [2,5]
C0205081
UMLS CUI [2,6]
C0205082
UMLS CUI [2,7]
C4759838
UMLS CUI [2,8]
C0015967
UMLS CUI [2,9]
C4330693
UMLS CUI [2,10]
C1283330
UMLS CUI [2,11]
C5453203
*Exclusion Criteria:*
Beschreibung

*Exclusion Criteria:*

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
Beschreibung

For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042200
UMLS CUI [1,2]
C0314603
UMLS CUI [1,3]
C0001675
UMLS CUI [1,4]
C0339901
UMLS CUI [1,5]
C0521026
Is undergoing immunosuppression as a result of an underlying illness or treatment.
Beschreibung

Is undergoing immunosuppression as a result of an underlying illness or treatment.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C5555332
Has an active neoplastic disease or a history of any hematologic malignancy.
Beschreibung

Has an active neoplastic disease or a history of any hematologic malignancy.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C2707252
UMLS CUI [2,1]
C3696964
Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.
Beschreibung

Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C4733047
UMLS CUI [1,3]
C0574135
UMLS CUI [1,4]
C0021081
UMLS CUI [1,5]
C0304497
Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Beschreibung

Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0021027
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0456388
UMLS CUI [1,5]
C4086725
UMLS CUI [1,6]
C1442880
UMLS CUI [1,7]
C4528312
Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
Beschreibung

Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0036341
UMLS CUI [1,3]
C0005586
UMLS CUI [1,4]
C4534351
Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
Beschreibung

Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0023636
UMLS CUI [1,3]
C0042212
UMLS CUI [1,4]
C3494354
UMLS CUI [1,5]
C0332168
UMLS CUI [1,6]
C0332152
UMLS CUI [1,7]
C4528312
Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
Beschreibung

Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).

Datentyp

boolean

Alias
UMLS CUI [1,1]
C5545294
UMLS CUI [1,2]
C4061114
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C1519202
UMLS CUI [1,5]
C0011849
UMLS CUI [1,6]
C0023895
UMLS CUI [1,7]
C0376387
UMLS CUI [1,8]
C0027765
UMLS CUI [1,9]
C0022658
Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week prior to vaccination.
Beschreibung

Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week prior to vaccination.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C1959900
UMLS CUI [1,3]
C1948053
UMLS CUI [1,4]
C0332152
UMLS CUI [1,5]
C0042196
Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in the study.
Beschreibung

Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in the study.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0871738
UMLS CUI [1,3]
C5399710
UMLS CUI [1,4]
C0013227
UMLS CUI [1,5]
C0205460
UMLS CUI [1,6]
C0456388
UMLS CUI [1,7]
C1948053
UMLS CUI [1,8]
C0332152
UMLS CUI [1,9]
C4528312
Is planning to enroll in another clinical trial at any time during the study period.
Beschreibung

Is planning to enroll in another clinical trial at any time during the study period.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301732
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C1705242
UMLS CUI [1,4]
C0947630
UMLS CUI [1,5]
C0347984
UMLS CUI [1,6]
C1948053
Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
Beschreibung

Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0019163
UMLS CUI [1,3]
C0019196
Has a history of alcohol or drug abuse in the last 5 years.
Beschreibung

Has a history of alcohol or drug abuse in the last 5 years.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0237123
UMLS CUI [1,2]
C1948053
Has a history of Guillain-Barre syndrome.
Beschreibung

Has a history of Guillain-Barre syndrome.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0018378
Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Beschreibung

Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4745084
UMLS CUI [1,2]
C1710101
UMLS CUI [1,3]
C0600219
UMLS CUI [1,4]
C1883420
UMLS CUI [1,5]
C0035647
UMLS CUI [1,6]
C3263722
UMLS CUI [1,7]
C1299582
UMLS CUI [1,8]
C0525058
Is pregnant, has not practiced acceptable prophylaxis for the past three months and will not do so for the next three months, or anticipates becoming pregnant for the duration of the study.
Beschreibung

Is pregnant, has not practiced acceptable prophylaxis for the past three months and will not do so for the next three months, or anticipates becoming pregnant for the duration of the study.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [2,1]
C2219720
UMLS CUI [2,2]
C1948053
UMLS CUI [2,3]
C1444637
UMLS CUI [3,1]
C0558080
UMLS CUI [3,2]
C3242006
UMLS CUI [3,3]
C1948053
UMLS CUI [3,4]
C0016884
UMLS CUI [4,1]
C3840775
UMLS CUI [4,2]
C0032961
Is a known relative of a previously enrolled study subject.
Beschreibung

Is a known relative of a previously enrolled study subject.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0080103
UMLS CUI [1,2]
C1516879
UMLS CUI [1,3]
C0205156
UMLS CUI [1,4]
C0681850
Positive urine pregnancy test, or breast feeding.
Beschreibung

Positive urine pregnancy test, or breast feeding.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0430059
UMLS CUI [1,2]
C0006147
For "Adult Influenza Vaccine Genetics" only: Has received an influenza vaccine in the past three years.
Beschreibung

For "Adult Influenza Vaccine Genetics" only: Has received an influenza vaccine in the past three years.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0314603
UMLS CUI [2,1]
C3476067
UMLS CUI [2,2]
C3843792
For "Adult Influenza Vaccine Genetics" only: Has a known allergy to eggs, chicken protein or other components of the vaccine.
Beschreibung

For "Adult Influenza Vaccine Genetics" only: Has a known allergy to eggs, chicken protein or other components of the vaccine.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021403
UMLS CUI [1,2]
C0559469
UMLS CUI [1,3]
C2702614
UMLS CUI [1,4]
C0455593
For "Adult Influenza Vaccine Genetics" only: Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
Beschreibung

For "Adult Influenza Vaccine Genetics" only: Has a history of severe reactions following immunization with contemporary influenza virus vaccines.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0021403
UMLS CUI [1,3]
C0314603
UMLS CUI [1,4]
C3242604
UMLS CUI [1,5]
C0262926
UMLS CUI [1,6]
C0020971
For "Adult Influenza Vaccine Genetics" only: Is of non-European heritage.
Beschreibung

For "Adult Influenza Vaccine Genetics" only: Is of non-European heritage.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0021403
UMLS CUI [1,3]
C0314603
UMLS CUI [1,4]
C2986513
UMLS CUI [1,5]
C1518422
UMLS CUI [1,6]
C0239307
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Eligibility Criteria

9 Formulare
  1. StudyEvent: SEV1
    1. Eligibility Criteria
    2. This subject consent data table contains subject IDs, consent group information, subject aliases, and affection status (all subjects are controls).
    3. This subject sample mapping data table includes a mapping of study subject IDs to sample IDs. Samples are the final preps submitted for genotyping, sequencing, and/or expression data. For example, if one patient (subject ID) gave one sample, and that sample was processed differently to generate 2 sequencing runs, there would be two rows, both using the same subject ID, but having 2 unique sample IDs. The data table also includes the study/substudy (phs accession) that the sample belongs to and sample use.
    4. This subject phenotype data table includes subject sex, race, age, year of enrollment, log2 antibody titers (n=18 variables; Assays: hemagglutination inhibition and neutralization; Antigens: H1N1, H3N2, FluB; Time: preimmune, 14 days, and 28 days).
    5. This sample attributes data table includes body site where sample was collected, analyte type, and genotyping center.
    6. This sample GEO mapping data table includes a mapping of sample IDs to GEO accession IDs, and RNA IDs collected at each study visit.
    7. This subject phenotype data table includes subject sex, age, year of enrollment, receipt of seasonal influenza vaccine (n=3; 2008-2010), recipet of 2009 pH1N1 swine influenza vaccine, virus detected in nasal wash, antiviral drug taken by subjects, maximum oral temperature on first day of illness, duration of symptoms, and log2 antibody titers (n=4 variables; hemagglutination inhibition assay; Time: baseline, acute infection, convalescent, and spring).
    8. This sample attributes data table includes body site where sample was collected, analyte type, genotyping and sequencing centers, and sample collection date.
    9. This subject GEO mapping data table includes a mapping of subject IDs to GEO accession IDs, and RNA IDs collected different time points.
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion and exclusion criteria
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
*Inclusion Criteria:*
Item
*Inclusion Criteria:*
boolean
C1512693 (UMLS CUI [1,1])
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
Item
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
boolean
C0042200 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C0001675 (UMLS CUI [1,3])
C0339901 (UMLS CUI [1,4])
C0521026 (UMLS CUI [1,5])
Adults age 18 to 49 at Texas A&M University and in the community.
Item
Adults age 18 to 49 at Texas A&M University and in the community.
boolean
C0001675 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
In good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
Item
In good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
boolean
C1277245 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
C1532216 (UMLS CUI [1,5])
C0262926 (UMLS CUI [1,6])
C0031809 (UMLS CUI [1,7])
Able to understand and comply with planned study procedures.
Item
Able to understand and comply with planned study procedures.
boolean
C0525058 (UMLS CUI [1,1])
Provides informed consent prior to any study procedures and is available for all study visits.
Item
Provides informed consent prior to any study procedures and is available for all study visits.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C1512346 (UMLS CUI [1,4])
Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine device, and/or a licensed hormonal method) for the study period.
Item
Women of childbearing potential (not surgically sterile or postmenopausal for ≥1 year) must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine device, and/or a licensed hormonal method) for the study period.
boolean
C4324275 (UMLS CUI [1,1])
C0680240 (UMLS CUI [1,2])
C4546343 (UMLS CUI [1,3])
C0205411 (UMLS CUI [1,4])
C0004764 (UMLS CUI [1,5])
C0036899 (UMLS CUI [1,6])
C0021900 (UMLS CUI [1,7])
C5768052 (UMLS CUI [1,8])
C1948053 (UMLS CUI [1,9])
For "Acute Viral Respiratory Infection Genetics" only: Able to report to the study site within 48 hours of onset with a moderate or severe ARI (with fever or that causes them to miss school, work, or social activities) during the surveillance period.
Item
For "Acute Viral Respiratory Infection Genetics" only: Able to report to the study site within 48 hours of onset with a moderate or severe ARI (with fever or that causes them to miss school, work, or social activities) during the surveillance period.
boolean
C0729531 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C1299581 (UMLS CUI [2,1])
C2825164 (UMLS CUI [2,2])
C0332168 (UMLS CUI [2,3])
C0332162 (UMLS CUI [2,4])
C0205081 (UMLS CUI [2,5])
C0205082 (UMLS CUI [2,6])
C4759838 (UMLS CUI [2,7])
C0015967 (UMLS CUI [2,8])
C4330693 (UMLS CUI [2,9])
C1283330 (UMLS CUI [2,10])
C5453203 (UMLS CUI [2,11])
*Exclusion Criteria:*
Item
*Exclusion Criteria:*
boolean
C0680251 (UMLS CUI [1,1])
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
Item
For both "Adult Influenza Vaccine Genetics" and "Acute Viral Respiratory Infection Genetics":
boolean
C0042200 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C0001675 (UMLS CUI [1,3])
C0339901 (UMLS CUI [1,4])
C0521026 (UMLS CUI [1,5])
Is undergoing immunosuppression as a result of an underlying illness or treatment.
Item
Is undergoing immunosuppression as a result of an underlying illness or treatment.
boolean
C0021079 (UMLS CUI [1,1])
C5555332 (UMLS CUI [1,2])
Has an active neoplastic disease or a history of any hematologic malignancy.
Item
Has an active neoplastic disease or a history of any hematologic malignancy.
boolean
C1882062 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C3696964 (UMLS CUI [2,1])
Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.
Item
Is using oral or parenteral steroids or other immunosuppressive or cytotoxic drugs.
boolean
C0087111 (UMLS CUI [1,1])
C4733047 (UMLS CUI [1,2])
C0574135 (UMLS CUI [1,3])
C0021081 (UMLS CUI [1,4])
C0304497 (UMLS CUI [1,5])
Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Item
Has a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
boolean
C0262926 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0456388 (UMLS CUI [1,4])
C4086725 (UMLS CUI [1,5])
C1442880 (UMLS CUI [1,6])
C4528312 (UMLS CUI [1,7])
Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
Item
Has a diagnosis of schizophrenia, bipolar disease or other major psychiatric diagnosis.
boolean
C0011900 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C0005586 (UMLS CUI [1,3])
C4534351 (UMLS CUI [1,4])
Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
Item
Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
boolean
C0042196 (UMLS CUI [1,1])
C0023636 (UMLS CUI [1,2])
C0042212 (UMLS CUI [1,3])
C3494354 (UMLS CUI [1,4])
C0332168 (UMLS CUI [1,5])
C0332152 (UMLS CUI [1,6])
C4528312 (UMLS CUI [1,7])
Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
Item
Has an acute or chronic medical condition that, in the opinion of the investigator would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
boolean
C5545294 (UMLS CUI [1,1])
C4061114 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C1519202 (UMLS CUI [1,4])
C0011849 (UMLS CUI [1,5])
C0023895 (UMLS CUI [1,6])
C0376387 (UMLS CUI [1,7])
C0027765 (UMLS CUI [1,8])
C0022658 (UMLS CUI [1,9])
Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week prior to vaccination.
Item
Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week prior to vaccination.
boolean
C4061114 (UMLS CUI [1,1])
C1959900 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in the study.
Item
Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in the study.
boolean
C0087111 (UMLS CUI [1,1])
C0871738 (UMLS CUI [1,2])
C5399710 (UMLS CUI [1,3])
C0013227 (UMLS CUI [1,4])
C0205460 (UMLS CUI [1,5])
C0456388 (UMLS CUI [1,6])
C1948053 (UMLS CUI [1,7])
C0332152 (UMLS CUI [1,8])
C4528312 (UMLS CUI [1,9])
Is planning to enroll in another clinical trial at any time during the study period.
Item
Is planning to enroll in another clinical trial at any time during the study period.
boolean
C1301732 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C1705242 (UMLS CUI [1,3])
C0947630 (UMLS CUI [1,4])
C0347984 (UMLS CUI [1,5])
C1948053 (UMLS CUI [1,6])
Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
Item
Has known active human immunodeficiency virus, hepatitis B or hepatitis C infection.
boolean
C0019693 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
Has a history of alcohol or drug abuse in the last 5 years.
Item
Has a history of alcohol or drug abuse in the last 5 years.
boolean
C0237123 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Has a history of Guillain-Barre syndrome.
Item
Has a history of Guillain-Barre syndrome.
boolean
C0262926 (UMLS CUI [1,1])
C0018378 (UMLS CUI [1,2])
Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Item
Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
boolean
C4745084 (UMLS CUI [1,1])
C1710101 (UMLS CUI [1,2])
C0600219 (UMLS CUI [1,3])
C1883420 (UMLS CUI [1,4])
C0035647 (UMLS CUI [1,5])
C3263722 (UMLS CUI [1,6])
C1299582 (UMLS CUI [1,7])
C0525058 (UMLS CUI [1,8])
Is pregnant, has not practiced acceptable prophylaxis for the past three months and will not do so for the next three months, or anticipates becoming pregnant for the duration of the study.
Item
Is pregnant, has not practiced acceptable prophylaxis for the past three months and will not do so for the next three months, or anticipates becoming pregnant for the duration of the study.
boolean
C0032961 (UMLS CUI [1,1])
C2219720 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1444637 (UMLS CUI [2,3])
C0558080 (UMLS CUI [3,1])
C3242006 (UMLS CUI [3,2])
C1948053 (UMLS CUI [3,3])
C0016884 (UMLS CUI [3,4])
C3840775 (UMLS CUI [4,1])
C0032961 (UMLS CUI [4,2])
Is a known relative of a previously enrolled study subject.
Item
Is a known relative of a previously enrolled study subject.
boolean
C0080103 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
C0681850 (UMLS CUI [1,4])
Positive urine pregnancy test, or breast feeding.
Item
Positive urine pregnancy test, or breast feeding.
boolean
C0430059 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
For "Adult Influenza Vaccine Genetics" only: Has received an influenza vaccine in the past three years.
Item
For "Adult Influenza Vaccine Genetics" only: Has received an influenza vaccine in the past three years.
boolean
C0021403 (UMLS CUI [1,1])
C0314603 (UMLS CUI [1,2])
C3476067 (UMLS CUI [2,1])
C3843792 (UMLS CUI [2,2])
For "Adult Influenza Vaccine Genetics" only: Has a known allergy to eggs, chicken protein or other components of the vaccine.
Item
For "Adult Influenza Vaccine Genetics" only: Has a known allergy to eggs, chicken protein or other components of the vaccine.
boolean
C0021403 (UMLS CUI [1,1])
C0559469 (UMLS CUI [1,2])
C2702614 (UMLS CUI [1,3])
C0455593 (UMLS CUI [1,4])
For "Adult Influenza Vaccine Genetics" only: Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
Item
For "Adult Influenza Vaccine Genetics" only: Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
boolean
C0001675 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
C0314603 (UMLS CUI [1,3])
C3242604 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,5])
C0020971 (UMLS CUI [1,6])
For "Adult Influenza Vaccine Genetics" only: Is of non-European heritage.
Item
For "Adult Influenza Vaccine Genetics" only: Is of non-European heritage.
boolean
C0001675 (UMLS CUI [1,1])
C0021403 (UMLS CUI [1,2])
C0314603 (UMLS CUI [1,3])
C2986513 (UMLS CUI [1,4])
C1518422 (UMLS CUI [1,5])
C0239307 (UMLS CUI [1,6])
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