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])
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])