COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04383574

Yuliang Zhao

yuliang_zh@163.com

2020-05-12

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - healthy adults aged ≥60 years; - be able to understand and sign the informed consent voluntarily; - provide legal identification;

- travel / residence history of wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment; - contact with sars-cov-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment; - contact patients with fever or respiratory symptoms from wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment; - two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment; - history of sars; - history of sars-cov-2 infection; - history of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema; - congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc; - autoimmune disease or immunodeficiency / immunosuppression; - serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc; - serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis; - thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months; - long history of alcohol or drug abuse; - receipt of blood products 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; - acute diseases or acute exacerbation of chronic diseases in the past 7 days; - axillary temperature >37.0°c; - according to the investigator's judgment, the subject has any other factors that are not suitable for the clinical trial.

4

Sinovac Life Sciences Co., Ltd.

60

100

China

Healthy volunteers

N/A

422

Immunogenicity index-seroconversion rates of neutralizing antibody;Safety index-incidence of adverse reactions

None

Phase 1/Phase 2

[{"arm_notes": "300SU/0.5ml;2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "600SU/0.5ml;2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1200SU/0.5ml;2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]