study of the commercial scale sars-cov-2 vaccine against the pilot scale among adults, and bridging study of the immunogenicity in elderly against that in adults

Conditions: Covid19

Summary: this study is a randomized, double-blinded clinical trial, to evaluate the non-inferiority of the commercial scale inactivated sars-cov-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults.

this study is a randomized, double-blinded clinical trial, to evaluate the non-inferiority of the commercial scale inactivated sars-cov-2 vaccine against that of the pilot scale among adults aged 26-45 years, and the open-labelled, bridging non-inferiority of the vaccine induced immunogenicity in elderly against that in adults. the experimental vaccine was manufactured by sinovac research \& development co.,ltd. totally 1040 subjects，including: 130 subjects aged 18\~25 years; 520 subjects aged 26\~45 years, with 260 in each group; 130 subjects aged 46\~59 years; 260 subjects aged ≥60 years. subjects will be assigned to receive two doses of medium-dosage vaccine on the schedule of 0,14.

Eligibility criteria:
inclusion criteria: 1. healthy adults aged 18-59 or elderly aged ≥60 years; 2. proven legal identity. exclusion criteria: 1. travel/residence history of communities with reported cases within 14 days before trial; 2. history of exposure to novel coronavirus infection (nucleic acid positive) within 14 days prior to the trial; 3. exposed to patients with fever or respiratory symptoms from communities with reported cases within 14 days prior to the trial; 4. two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial; 5. history of sars-cov-2 infection; 6. history of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema; 7. congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 8. autoimmune disease or immunodeficiency/immunosuppression; 9. patients with serious chronic diseases, serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.; 10. serious neurological disorder (epilepsy, convulsions or convulsions) or psychosis; 11. history of thyroid disease or thyroidectomy, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy caused by any circumstance; 12. coagulation dysfunction (such as coagulation factor deficiency, coagulation disease, platelet abnormality) or obvious bruising or coagulation disorder diagnosed by doctors; 13. immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months; 14. long history of alcohol or drug abuse; 15. received blood products within 3 months prior to receiving the vaccine; 16. received other research drugs within 30 days prior to receiving the vaccine; 17. received live attenuated vaccine within 14 days prior to receiving the vaccine; 18. received subunit or inactivated vaccine within 7 days prior to receiving the vaccine; 19. onset of various acute or chronic diseases within 7 days prior to the study; 20. axillary temperature of \>37.0℃ before inoculation of the vaccine; 21. those who are already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to become pregnant within 2 months; 22. in the opinion of the investigator, the participants had any other factors that made them unsuitable to participate in the clinical trial.