COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=129744

Li Fangjun

646022285@qq.com

2021-07-07

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Aged 3-17 years (both inclusive), 2. The subject voluntarily agrees to participate in the research (or the subject's legal guardian voluntarily agrees that the child participates in the research), the guardian and the subject (8-17 years old) sign the informed consent form, and can provide valid identification, comply with the requirements of the test protocol, 3. The subject and/or the subject's legal guardian has the ability to understand (non-literate) research procedures and to participate in planned follow-up visits, 4. Underarm body temperature <37.3? (>14 years old), armpit body temperature <37.5? (<=14 years old), 5. Subjects of childbearing age agree to take effective contraceptive measures during the study.

1. The results of physical examination and laboratory examination before screening are abnormal and clinically significant as determined by the clinician, 2. History of severe allergy to any component of the trial vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioedema, etc., or have a history of the above-mentioned serious side effects after using any vaccines or drugs in the past, 3. Those with a history of SARS and SARS-CoV-2 (meet any of the following: (1) Have a history of SARS and SARS-CoV-2 infection or disease in the past, (2) During the current SRAS-CoV-2 epidemic, there is a history of contact with confirmed/suspected patients of the new crown, (3) Detection of SARS-CoV-2 IgM and/or IgG antibody positive, (4) Real-time fluorescent RT-PCR nucleic acid positive,), 4. Antipyretics or pain relievers have been taken within 24 hours before the first dose of vaccination, 5. Those who have been vaccinated against the new coronavirus, or subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and live attenuated vaccine within 30 days, 6. Those suffering from the following diseases: (1) Acute (within 72 hours) febrile illness (aged >14 years, armpit temperature >=37.3?, aged <=14 years, armpit temperature >=37.5?), (2) Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days, (3) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc., (4) History of congenital or acquired immunodeficiency or autoimmune disease or receiving immunomodulatory treatment within 6 months, such as immunosuppressive dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than a week), or monoclonal antibody, or thymosin, or interferon, (5) Known to be diagnosed with infectious diseases, such as: active tuberculosis, viral hepatitis patients and/or human immunodeficiency virus HIV antibody positive or syphilis-specific antibody positive or parents are HIV-infected, (6) Neurological diseases or neurodevelopmental disorders (eg, migraine, epilepsy, stroke, seizure within the last three years, encephalopathy, focal neurological deficit, Guillain-Barre syndrome, encephalomyelitis, or transverse myelitis), psychiatric or family history, (7) Functional asplenia, as well as asplenia or splenectomy due to any cause, (8) Patients with serious chronic diseases or in advanced stages that cannot be controlled smoothly, such as diabetes and thyroid diseases, (9) Severe liver and kidney disease, current respiratory disease requiring daily drug treatment (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory disease (eg, asthma exacerbation) within the past 5 years, a history of severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis, (10) Thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc., (11) Cancer patients, 7. Received blood or blood-related products, including immune globulin, within 3 months, or planned to use it during the study, 8. Those who are pregnant (including positive urine pregnancy test), or are breastf

2

Hu'nan Provincial Center for Disease Control and Prevention

3

17

China

Healthy volunteers

N/A

0

SARS-CoV-2 neutralizing antibody;RBD protein binding antibody (IgG) ;

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 1

[{"arm_notes": "", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]