COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05112913

Weijun Hu, Master

huweijun0828@163.com

2021-11-09

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - healthy children aged 3-17; - 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.

- history of sars-cov-2 infection; - history of receiving covid-19 vaccine; - 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 (systemic lupus erythematosus)or immunodeficiency / immunosuppression(hiv,history after organ transplantation) - 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,absence of spleen, functional absence of spleen, absence of spleen due to any condition or splenectomy; - 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; - 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; - onset of various acute or chronic diseases within 7 days prior to the study; - axillary temperature >37.0°c; - the subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months; - already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months; - according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

7

Sinovac Research and Development Co., Ltd.

3

17

China

Healthy volunteers

N/A

2520

Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2

None

Phase 4

[{"arm_notes": "Lot 1", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 3", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 4", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 5", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 6", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Lot 7", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]