Healthy Volunteers | Age
Item
1. healthy people aged over 18 years old on the day of enrollment
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Axillary temperature
Item
2. axillary temperature is below than 37.0 ℃
boolean
C1531924 (UMLS CUI [1])
Blood pressure determination | Pharmaceutical Preparations | Pharmaceutical Preparations Absent
Item
3. blood pressure is not higher than 160/100 mmhg (with or without any medicine)
boolean
C0005824 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Healthy | Patient Eligible Vaccination | Medical History | Physical Examination
Item
4. judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
boolean
C3898900 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
Comprehension Study Protocol | Protocol Compliance
Item
5. able to understand this study information and willing to comply with all study requirements.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Informed Consent
Item
6. willing to participate in this study and sign informed consent form.
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status
Item
1. participated in any other clinical trial during the study period.
boolean
C2348568 (UMLS CUI [1])
Investigational New Drugs | Drugs, Non-Prescription | Vaccines
Item
2. use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Therapeutic immunosuppression | Immunoregulation Therapy | CORTICOSTEROIDS FOR SYSTEMIC USE | Exception Local Therapy
Item
3. received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
boolean
C0021079 (UMLS CUI [1])
C0678889 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C3653708 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C1517925 (UMLS CUI [4,2])
Immunoglobulins | Blood product | Immunoglobulins Planned | Blood product Planned
Item
4. administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
boolean
C0021027 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0021027 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0456388 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Vaccines, Inactivated | Vaccines, Attenuated
Item
5. administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
boolean
C0042212 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
Fever | Axillary temperature | Acute illness Requirement Antibiotics for systemic use | Acute illness Requirement Antiviral Therapy
Item
6. had a fever (axillary temperature over 38°c) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
boolean
C0015967 (UMLS CUI [1])
C1531924 (UMLS CUI [2])
C4061114 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3540704 (UMLS CUI [3,3])
C4061114 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0280274 (UMLS CUI [4,3])
Immunodeficiency | HIV carrier | Disease Organ Important | Malignant Neoplasms | Immune System Diseases | Lupus Erythematosus, Systemic | Other Coding | Splenectomy | Functional asplenia | Disease Affecting Immune response
Item
7. immunodeficiency (such as hiv carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
boolean
C0021051 (UMLS CUI [1])
C0853961 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0178784 (UMLS CUI [3,2])
C3898777 (UMLS CUI [3,3])
C0006826 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0024141 (UMLS CUI [6])
C3846158 (UMLS CUI [7])
C0037995 (UMLS CUI [8])
C0272405 (UMLS CUI [9])
C0012634 (UMLS CUI [10,1])
C0392760 (UMLS CUI [10,2])
C0301872 (UMLS CUI [10,3])
Disease allergic | Serious Adverse Event Post Vaccination | Hypersensitivity | Urticaria | Dyspnea | Angioedema | Abdominal Pain
Item
8. history of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
boolean
C0012634 (UMLS CUI [1,1])
C0700624 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0042196 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3])
C0042109 (UMLS CUI [4])
C0013404 (UMLS CUI [5])
C0002994 (UMLS CUI [6])
C0000737 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
9. pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity Vaccines Component
Item
10. allergic history to any component of this vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1705248 (UMLS CUI [1,3])
Medical condition Affecting Protocol Compliance | Psychological Factors Affecting Protocol Compliance | Social factor Affecting Protocol Compliance | Factor Occupational Affecting Protocol Compliance | Medical condition Affecting Informed Consent | Psychological Factors Affecting Informed Consent | Social factor Affecting Informed Consent | Factor Occupational Affecting Informed Consent
Item
11. other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0033898 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0337460 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
C1521761 (UMLS CUI [4,1])
C0521127 (UMLS CUI [4,2])
C0392760 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C3843040 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0021430 (UMLS CUI [5,3])
C0033898 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0021430 (UMLS CUI [6,3])
C0337460 (UMLS CUI [7,1])
C0392760 (UMLS CUI [7,2])
C0021430 (UMLS CUI [7,3])
C1521761 (UMLS CUI [8,1])
C0521127 (UMLS CUI [8,2])
C0392760 (UMLS CUI [8,3])
C0021430 (UMLS CUI [8,4])