Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:test vaccine
Control group:placebo
Sponsors
Hu'nan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 3-17 years (both inclusive); 2. The subject voluntarily agrees to participate in the research (or the subject's legal guardian voluntarily agrees that the child participates in the research), the guardian and the subject (8-17 years old) sign the informed consent form, and can provide valid identification; comply with the requirements of the test protocol; 3. The subject and/or the subject's legal guardian has the ability to understand (non-literate) research procedures and to participate in planned follow-up visits; 4. Underarm body temperature 14 years old), armpit body temperature <37.5? (<=14 years old); 5. Subjects of childbearing age agree to take effective contraceptive measures during the study.
Exclusion criteria
Exclusion criteria: 1. The results of physical examination and laboratory examination before screening are abnormal and clinically significant as determined by the clinician; 2. History of severe allergy to any component of the trial vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc.; or have a history of the above-mentioned serious side effects after using any vaccines or drugs in the past; 3. Those with a history of SARS and SARS-CoV-2 (meet any of the following: (1) Have a history of SARS and SARS-CoV-2 infection or disease in the past; (2) During the current SRAS-CoV-2 epidemic, there is a history of contact with confirmed/suspected patients of the new crown; (3) Detection of SARS-CoV-2 IgM and/or IgG antibody positive; (4) Real-time fluorescent RT-PCR nucleic acid positive;); 4. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination; 5. Those who have been vaccinated against the new coronavirus, or subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and live attenuated vaccine within 30 days; 6. Those suffering from the following diseases: (1) Acute (within 72 hours) febrile illness (aged >14 years, armpit temperature >=37.3?; aged =37.5?); (2) Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; (3) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; (4) History of congenital or acquired immunodeficiency or autoimmune disease or receiving immunomodulatory treatment within 6 months, such as immunosuppressive dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than a week); or monoclonal antibody; or thymosin; or interferon; (5) Known to be diagnosed with infectious diseases, such as: active tuberculosis, viral hepatitis patients and/or human immunodeficiency virus HIV antibody positive or syphilis-specific antibody positive or parents are HIV-infected; (6) Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy, stroke, seizure within the last three years, encephalopathy, focal neurological deficit, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis); psychiatric or family history; (7) Functional asplenia, as well as asplenia or splenectomy due to any cause; (8) Patients with serious chronic diseases or in advanced stages that cannot be controlled smoothly, such as diabetes and thyroid diseases; (9) Severe liver and kidney disease; current respiratory disease requiring daily drug treatment (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory disease (eg, asthma exacerbation) within the past 5 years; a history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis; (10) Thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc.; (11) Cancer patients; 7. Received blood or blood-related products, including immune globulin, within 3 months; or planned to use it during the study; 8. Those who are pregnant (including positive urine pregnancy test), or are breastf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody;RBD protein binding antibody (IgG) ; | — |
Countries
China
Contacts
Public ContactLi Fangjun
Hu'nan Provincial Center for Disease Control and Prevention
Outcome results
None listed