COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04993365

Zhuhang Huang

Not reported

2021-08-06

Completed

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: children aged 3-5 years ; the subject and/or guardian can understand and voluntarily sign the informed consent form proven legal identity;

history of contact with a sars-cov-2 infection (positive in nucleic acid test) within 14 days; history of multiple system inflammatory syndrome (mis-c); history of hand, foot and mouth disease, herpetic angina or ev71 vaccination; 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, 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 noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; history of 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; severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; axillary temperature >37.0°c; the subjects participated in other clinical trials during the follow-up period, or will be planned 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 Research and Development Co., Ltd.

3

5

China

Healthy volunteers

N/A

520

Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71;Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2

None

Phase 4

[{"arm_notes": "combined immunization group", "treatment_id": 2039, "treatment_name": "Ev71 vaccine+inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Non covid vaccine+inactivated virus", "pharmacological_treatment": "Non covid vaccine+vaccine"}, {"arm_notes": "Non-combined immunization group", "treatment_id": 2039, "treatment_name": "Ev71 vaccine+inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Non covid vaccine+inactivated virus", "pharmacological_treatment": "Non covid vaccine+vaccine"}]