Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Minor group:Experimental vaccination
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
3 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. At least 3 ~ 17 years old (both included); 2. The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol; 3. The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements; 4. There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period; 5. Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination.
Exclusion criteria
Exclusion criteria: 1. The results of the physical examination during the screening period are abnormal and have clinical significance as determined by the clinician (not suitable for vaccination); 2. Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (>14 years old, axillary body temperature >=37.3 degree; =37.5 degree); 3. Have a history of severe allergy to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioedema, etc.; or any previous history of History of the above-mentioned serious side effects after the use of vaccines or drugs; 4. Those with a history of SARS and SARS-CoV-2; 5. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination; 6. Those who have been vaccinated against the new coronavirus, or vaccinated with subunit vaccine and/or inactivated vaccine within 7 days before the first dose of vaccine, or vaccinated with live attenuated vaccine within 14 days; 7. Received blood or blood-related products, including immune globulin, within 3 months before the experimental vaccine; or planned to use it during the study; 8. Those suffering from the following diseases: suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; congenital or acquired immunity History of deficiency or autoimmune disease or treatment with immunomodulatory agents within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/day for more than one week); or monoclonal antibodies; or thymosin ; or interferon, etc.; but topical medication (such as ointment, eye drops, inhalation, or nasal spray) is allowed; known to be diagnosed with an existing infectious disease, such as: active tuberculosis, viral hepatitis, Human immunodeficiency virus infection or Treponema pallidum infection; neurological disease or neurodevelopmental dysplasia (eg, convulsions, migraine, epilepsy, stroke, seizures within the last three years, encephalopathy, focal neurological deficit, Guillain- Barre syndrome, encephalomyelitis, or transverse myelitis); psychiatric or family history; functional asplenia, and any cause of asplenia or splenectomy; severe chronic disease or disease that is progressive and uncontrolled, Such as diabetes, hypertension uncontrolled by medication; severe liver and kidney disease; current respiratory disease requiring daily medication (eg, chronic obstructive pulmonary disease [COPD], asthma) or worsening of respiratory disease within the past 5 years (eg, asthma exacerbations); history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis ; Patients with thrombocytopenia, any coagulation disorder or receiving anticoagulant therapy, etc.; Cancer patients (except basal cell carcinoma); 9. Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test); 10. Those who have participated in or are participating in other clinical trials related visits have not ended, or are clearly vaccinated against the new crown
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody;RBD protein binding antibody (IgG) detection; | — |
Countries
China
Contacts
Public ContactLi Fangjun
Hunan Provincial Center for Disease Control and Prevention
Outcome results
None listed