COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04884685

Yuliang Zhao, Master

yuliang_zh@163.com

2021-05-13

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

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.

- 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.

2

Sinovac Life Sciences Co., Ltd.

3

17

China

Healthy volunteers

N/A

500

Safety index-incidence of adverse reactions

None

Phase 2

[{"arm_notes": "600SU in 0.5mL;2;Days0-28;IM", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]