COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04758273

Beijing Minhai Biotechnology Co., Ltd

Not reported

2021-02-17

Unknown

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: healthy permanent residents aged 18 years and above; subjects agree to sign the informed consent forms voluntarily; subjects are able to comply with the requirements of the clinical trial protocol; armpit temperature <=37.0 degree c; female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.

within 14 days before vaccination, subjects have been abroad and to villages/communities experienced covid-19 epidemics, and in contact with covid-19 cases or suspected cases. subjects are under isolation observation, or living in the villages/communities with covid-19 cases or suspected cases; confirmed cases, suspected cases or asymptomatic cases with covid-19 (refer to information system of china disease prevention and control); subjects with history of sars virus infection by self-reported; positive in throat swab through rt-pcr; positive in sars-cov-2 antibody test; subjects with abnormal indicators, such as blood biochemistry, blood routine, urine routine and coagulation function which might show clinical meaning, before administration; subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated sars-cov-2 vaccine; subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmhg, diastolic pressure >=90 mmhg; subjects aged >=60 years with systolic pressure >=150 mmhg, diastolic pressure >=100 mmhg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; subjects diagnosed with congenital or acquired immune deficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; subjects with history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease); subjects receiving anti-tb treatment; subjects receiving other research drugs within 6 months before vaccination; subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); subjects receiving blood products within 3 months before administration; subjects vaccinated with live attenuated vaccine within 14 days before vaccination; subjects vaccinated with other vaccine within 7 days before vaccination; the researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.

5

Beijing Minhai Biotechnology Co., Ltd

18

100

China

Healthy volunteers

N/A

180

Incidence of adverse reactions/events

None

Phase 1

[{"arm_notes": "medium dosage;2;day 0, 14(18~59 years)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dosage;2;day 0, 14(18~59 years)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "medium dosage;3;day 0, 28, 56(18~59 years, >59 years)", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dosage;3;day 0, 28, 56 (18~59 years, >59 years)", "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"}]