COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=134642

Tao Huang

ymlc01@hncdc.com

2021-09-29

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1) Persons aged 18 and above, 2) The subject has independent judgment ability, can read, understand and complete the vaccination diary card, and voluntarily participates in it and signs the informed consent, 3) The subject can comply with the requirements of the clinical trial protocol, 4) Armpit temperature <= 37.2 degrees C, 5) No birth plan in the first 3 months after enrollment (including male subjects' partners), Effective contraceptive measures were taken within 2 weeks prior to enrollment.

Exclusion criteria for first dose: 1) Within 14 days prior to vaccination, travel abroad and villages/communities affected by COVID-19, contact with novel coronavirus infected or suspected cases, persons in the quarantine period, or novel coronavirus infected or suspected cases in the same village/community, 2)Novel coronavirus cases, suspected cases or asymptomatic infected persons, 3) Received other COVID-19 vaccines before enrollment, 4) SarS-COV-2 nucleic acid or antibody (IgG or IgM) test results are positive, 5) Women with positive pregnancy test, or in lactation, 6) Have a history of SARS and MERS virus infection, 7) Past severe allergic reaction to vaccination or allergy to known components of novel coronavirus inactivated vaccine (aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride), 8) History or family history of convulsions, epilepsy, encephalopathy and mental illness, 9) Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., 10) Within 3 days prior to vaccination, suffering from acute diseases or acute episodes of chronic diseases, or having used antipyretic, analgesic and antiallergic drugs, 11) Known or suspected diseases include: serious respiratory disease, serious cardiovascular disease, serious liver and kidney disease, hypertension beyond drug control (18-59 years: systolic blood pressure >= 140mmHg, diastolic blood pressure >= 90mmHg, Systolic blood pressure >= 160mmHg, diastolic blood pressure >= 100 mmHg), diabetes mellitus (unstable blood glucose control, or inability to control blood glucose with medication, or diabetes complications), malignant tumor, 12) have been diagnosed with congenital or acquired immune deficiency, or are suspected of having a systemic disease that may interfere with the conduct or completion of the study, such as active tuberculosis, current viral hepatitis, positive initial screening of human immunodeficiency virus (HIV), syphilis infection (positive specific antibody to syphilis), etc., 13) There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, 14) Receiving other study drugs within 6 months prior to vaccination, 15) Those who received immunobooster or inhibitor treatment within 3 months prior to vaccination (continuous oral or drip for more than 14 days), 16) Received blood products within 3 months before vaccination (including but not limited to immunoglobulin products, albumin products, coagulation products, etc.), 17) Received live attenuated vaccine within 14 days prior to vaccination, or received other vaccines other than live attenuated vaccine within 7 days prior to vaccination, 18) No spleen or abnormal splenic function, 19) Other conditions that the investigator determines are not suitable for participation in the clinical trial. Exclusion criteria for the second dose: 1) Have received other COVID-19 vaccines after the first dose exemption, 2) The newly discovered cases that meet the exclusion criteria are not suitable for follow-up vaccination after evaluation by researchers, 3) The occurrence of any major disease that would pose additional risk to the subject if he/she continues to participate in the study, 4) Severe acute allergic reaction (grade 3 or above) after the first dose of vaccine, 5) Occurrence of vaccine-related SAE, 6) Positive pregnancy

5

Hunan Provincial Center for Disease Control and Prevention

18

100

China

Healthy volunteers

N/A

600

Humoral immunity (IgG; neutralizing antibody);

| Declared number of arm (3.0) differs from found arms (5.0)

Phase 2

[{"arm_notes": "Low dose;1;18-59 years old", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose;1;18-59 years old", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Low dose;1;18-59 years old", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose;1;18-59 years old", "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"}]