ID

39747

Beskrivning

Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）; ODM derived from: https://clinicaltrials.gov/show/NCT02189603

Länk

https://clinicaltrials.gov/show/NCT02189603

Nyckelord

Versioner (1)
  1. 2020-02-15 2020-02-15 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

15 februari 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis E NCT02189603

Engelsk

Eligibility Hepatitis E NCT02189603

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
Beskrivning

Healthy Volunteers | Age | Average intellect | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0423900
UMLS CUI [4]
C0021430
healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
Beskrivning

Healthy Volunteers Medical History | Healthy Volunteers Clinical examination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C1456356
subjects will reside in the study region in the next 7 months.
Beskrivning

Residence Study Site Region

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C2825164
UMLS CUI [1,3]
C0017446
free of history of hepatitis e.
Beskrivning

Free of Medical History Hepatitis E

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0262926
UMLS CUI [1,3]
C0085293
can comply with the request of study.
Beskrivning

Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0525058
axillary temperature is below 37 degree centigrade.
Beskrivning

Axillary temperature Degree Celsius

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1531924
UMLS CUI [1,2]
C0439237
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
for dose 1:
Beskrivning

Exclusion Criteria Dose Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0237753
receiving other vaccine or immunoglobulin within two weeks;
Beskrivning

Vaccine Other | Immunoglobulin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0021027
having serious allergic history to vaccine and medicine
Beskrivning

Vaccines allergy | Drug Allergy

Datatyp

boolean

Alias
UMLS CUI [1]
C0571550
UMLS CUI [2]
C0013182
eclampsia, epilepsy, encephalopathy and history of mental disease or family;
Beskrivning

Eclampsia | Epilepsy | Encephalopathy | Personal history of mental disorder | Family history of mental disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0013537
UMLS CUI [2]
C0014544
UMLS CUI [3]
C0085584
UMLS CUI [4]
C0260462
UMLS CUI [5]
C0455379
thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
Beskrivning

Thrombocytopenia Preventing Injection of muscle | Blood Coagulation Disorder Preventing Injection of muscle

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040034
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0565407
UMLS CUI [2,1]
C0005779
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0565407
fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, hiv or other factors;
Beskrivning

Immunologic Deficiency Syndrome | Immunologic Deficiency Syndrome Suspected | Immunosuppressant drug therapy | Defect Genetic | HIV | Factor Other

Datatyp

boolean

Alias
UMLS CUI [1]
C0021051
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C1096650
UMLS CUI [4,1]
C1457869
UMLS CUI [4,2]
C0314603
UMLS CUI [5]
C0019682
UMLS CUI [6,1]
C1521761
UMLS CUI [6,2]
C0205394
congenital malformation, eccyliosis or severe chronic disease;
Beskrivning

Congenital Abnormality | Developmental Disability | Chronic disease Severe

Datatyp

boolean

Alias
UMLS CUI [1]
C0000768
UMLS CUI [2]
C0008073
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0205082
fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
Beskrivning

Disease Other | Disease Other Suspected | Fever | Communicable Disease | Liver disease | Kidney Disease | Cardiovascular Disease | Malignant Neoplasms | Acute Disease | Chronic disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0750491
UMLS CUI [3]
C0015967
UMLS CUI [4]
C0009450
UMLS CUI [5]
C0023895
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0007222
UMLS CUI [8]
C0006826
UMLS CUI [9]
C0001314
UMLS CUI [10]
C0008679
joining other clinical study undergoing;
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
women pregnant or in lactation.
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
for dose 2 or 3:
Beskrivning

Exclusion Criteria Dose Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0237753
severe allergy for dose 1 or 2;
Beskrivning

Severe allergy Dose Number

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0237753
severe adverse reaction associated with last vaccination;
Beskrivning

Adverse reaction Associated with Vaccination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0042196
new occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
Beskrivning

Occurrence New Symptoms | Symptoms Fulfill Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C1457887
UMLS CUI [2,1]
C1457887
UMLS CUI [2,2]
C1550543
UMLS CUI [2,3]
C0680251
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Similar models

Eligibility Hepatitis E NCT02189603

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Age | Average intellect | Informed Consent
Item
healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0423900 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
Healthy Volunteers Medical History | Healthy Volunteers Clinical examination
Item
healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C1456356 (UMLS CUI [2,2])
Residence Study Site Region
Item
subjects will reside in the study region in the next 7 months.
boolean
C0237096 (UMLS CUI [1,1])
C2825164 (UMLS CUI [1,2])
C0017446 (UMLS CUI [1,3])
Free of Medical History Hepatitis E
Item
free of history of hepatitis e.
boolean
C0332296 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0085293 (UMLS CUI [1,3])
Protocol Compliance
Item
can comply with the request of study.
boolean
C0525058 (UMLS CUI [1])
Axillary temperature Degree Celsius
Item
axillary temperature is below 37 degree centigrade.
boolean
C1531924 (UMLS CUI [1,1])
C0439237 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Dose Number
Item
for dose 1:
boolean
C0680251 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Vaccine Other | Immunoglobulin
Item
receiving other vaccine or immunoglobulin within two weeks;
boolean
C0042210 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0021027 (UMLS CUI [2])
Vaccines allergy | Drug Allergy
Item
having serious allergic history to vaccine and medicine
boolean
C0571550 (UMLS CUI [1])
C0013182 (UMLS CUI [2])
Eclampsia | Epilepsy | Encephalopathy | Personal history of mental disorder | Family history of mental disorder
Item
eclampsia, epilepsy, encephalopathy and history of mental disease or family;
boolean
C0013537 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C0085584 (UMLS CUI [3])
C0260462 (UMLS CUI [4])
C0455379 (UMLS CUI [5])
Thrombocytopenia Preventing Injection of muscle | Blood Coagulation Disorder Preventing Injection of muscle
Item
thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
boolean
C0040034 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0565407 (UMLS CUI [1,3])
C0005779 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0565407 (UMLS CUI [2,3])
Immunologic Deficiency Syndrome | Immunologic Deficiency Syndrome Suspected | Immunosuppressant drug therapy | Defect Genetic | HIV | Factor Other
Item
fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, hiv or other factors;
boolean
C0021051 (UMLS CUI [1])
C0021051 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1096650 (UMLS CUI [3])
C1457869 (UMLS CUI [4,1])
C0314603 (UMLS CUI [4,2])
C0019682 (UMLS CUI [5])
C1521761 (UMLS CUI [6,1])
C0205394 (UMLS CUI [6,2])
Congenital Abnormality | Developmental Disability | Chronic disease Severe
Item
congenital malformation, eccyliosis or severe chronic disease;
boolean
C0000768 (UMLS CUI [1])
C0008073 (UMLS CUI [2])
C0008679 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Disease Other | Disease Other Suspected | Fever | Communicable Disease | Liver disease | Kidney Disease | Cardiovascular Disease | Malignant Neoplasms | Acute Disease | Chronic disease
Item
fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
boolean
C0012634 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0750491 (UMLS CUI [2,3])
C0015967 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
C0006826 (UMLS CUI [8])
C0001314 (UMLS CUI [9])
C0008679 (UMLS CUI [10])
Study Subject Participation Status
Item
joining other clinical study undergoing;
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
women pregnant or in lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Exclusion Criteria Dose Number
Item
for dose 2 or 3:
boolean
C0680251 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Severe allergy Dose Number
Item
severe allergy for dose 1 or 2;
boolean
C2945656 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Adverse reaction Associated with Vaccination
Item
severe adverse reaction associated with last vaccination;
boolean
C0559546 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
Occurrence New Symptoms | Symptoms Fulfill Exclusion Criteria
Item
new occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
boolean
C2745955 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C1457887 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
C0680251 (UMLS CUI [2,3])
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