safety of an inactivated sars-cov-2 vaccine (coronavac) in children and adolescents

Conditions: COVID-19

Summary: this study is a randomized, double-blinded, placebo-controlled, phase ⅱb clinical trial of an inactivated sars-cov-2 vaccine (coronavac) manufactured by sinovac life sciences co. , ltd.the purpose of this study is to evaluate the safety of the sars-cov-2 inactivated vaccine in healthy children and adolescents aged 3-17 years.

this study is a randomized, double-blinded, placebo-controlled,phase ⅱb clinical trial in children and adolescents aged 3-17 years. the experimental vaccine and placebo were both manufactured by sinovac life sciences co. , ltd. a total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.

Eligibility criteria:
inclusion criteria: * healthy children and adolescents aged 3-17 years; * the subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form); * proven legal identity. exclusion criteria: * travel history / residence history of communities with case reports within 14 days; * history of contact with a sars-cov-2 infection (positive in nucleic acid test) within 14 days; * have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days; * two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days; * history of sars-cov-2 infection; * history of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; * congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; * autoimmune disease or immunodeficiency / immunosuppression; * severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition; * diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; * immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; * history of alcohol or drug abuse; * acute diseases or acute exacerbation of chronic diseases in the past 7 days; * receipt of blood products within in the past 3 months; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * axillary temperature \>37.0°c; * already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.