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.
Biological: Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.
Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.
Biological: Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly
The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.
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.
Dafeng District Center for Disease Prevention and Control
Yancheng, Jiangsu, China
Hongxing Pan, Master, Principal Investigator
Jiangsu Provincial Center for Disease Prevention and Control