COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04551547

Yuliang Zhao, Master

yuliang_zh@163.com

2020-09-16

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - healthy children and adolescents aged 3-17 years; - the subject and/or guardian can understand and voluntarily sign the informed consent form (double sign required for 8-17 years old); - proven legal identity.

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; physical examination has clinically significant abnormal hematology and biochemistry laboratory test results that exceed the reference value range (only applicable to phase i clinical trials): blood routine test: white blood cell count, hemoglobin, platelet count; detection of blood biochemical indicators: alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin (tbil), creatinine (cr), fasting blood glucose; urine routine index: urine protein (pro); history of alcohol or drug abuse; 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; acute diseases or acute exacerbation of chronic diseases 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.

3

Sinovac Research and Development Co., Ltd.

3

17

China

Healthy volunteers

N/A

552

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

None

Phase 1/Phase 2

[{"arm_notes": "300SU/0.5ml;2;day0-28", "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;day0-28", "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"}]