Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
3-8 year old group:Vaccination
9-17 year old group:Vaccination
18-59 year old group:Vaccination
60-70 year old group:Vaccination
>=71 years old group:Vaccination
Sponsors
He'nan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
3 Years to 86 Years
Inclusion criteria
Inclusion criteria: 1. Age range: aged 3 and above (the group will be assigned according to age after enrollment); 2. Ask the medical history and physical examination, and the researcher judges that the physical condition is good; 3. Female patients were not pregnant at the time of enrollment (negative urine pregnancy test), not breastfeeding, and had no reproductive plan within the first 6 months after enrollment and took effective contraceptive measures; have taken effective contraceptive measures within 2 weeks before enrollment; 4. No history of new coronavirus vaccination before enrollment; 5. Able and willing to complete the entire prescribed research plan during the entire study follow-up period; 6. Patients or/and their legal guardians or delegates have the ability to understand the research procedures, sign the informed consent form voluntarily after informed consent, and be able to comply with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1. First dose exclusion criteria: (1) Confirmed cases, suspected cases or asymptomatic infections of the new coronavirus infection (check the ''China Disease Prevention and Control Information System''); (2) Have a history of SARS and MERS virus infection (self-report, on-site inquiry); (3) Underarm temperature of 14-year-old subjects >=37.3?, and underarm temperature of =37.5?; (4) Severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioedema or abdominal pain) or allergy to known components of the new coronavirus inactivated vaccine; (5) Severe respiratory disease, severe liver and kidney disease, hypertension (systolic blood pressure >= 160 mmHg, diastolic blood pressure >= 100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute exacerbations of chronic diseases; (6) Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; (7) History or family history of convulsions, epilepsy, encephalopathy or mental illness; (8) Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; (9) History of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease); (10) Those receiving immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days); (11) Have been vaccinated with live attenuated vaccine within 1 month before vaccination, and have received other vaccines within 14 days before vaccination; (12) Received blood products within 3 months before vaccination; (13) Received other research drugs within 6 months before vaccination; (14) Other circumstances judged by the investigator to be unsuitable to participate in this clinical trial. 2. Exclusion criteria for subsequent vaccinations: (1) Patients with high fever (axillary temperature >= 39.0?) for three days and severe allergic reaction after the previous dose of vaccine; (2) Serious adverse reactions that are causally related to the previous dose of vaccination; (3) Those newly discovered or newly discovered after the previous dose of vaccine do not meet the first-dose inclusion criteria or meet the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study; (4) Other reasons for exclusion considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-COVID-19 neutralizing antibody and IgG antibody 4 times growth rate, GMT and GMI;Incidence of any adverse reaction/event within 30 minutes of each vaccine dose;Incidence of adverse reactions/events on days 0 to 7 and 8 to 21/30 after each dose of vaccine;Incidence of serious adverse reactions within 6 months from first dose to full immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of anti-nCoV neutralizing antibody drops >=1:40, >=1:80 and >=1:160; | — |
Countries
China
Contacts
Public ContactXia Shengli
He'nan Provincial Center for Disease Control and Prevention
Outcome results
None listed