COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=66405

Jing Chen

524210737@qq.com

2021-01-01

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

1. Subjects aged 18-59 years, 2. The subjects who signed the informed consent form and participated voluntarily, 3. Subjects with good compliance, 4. Subjects with the interval of more than 14 days from the last vaccination, 5. Before entering this study, subjects with history and clinical examination and body temperature <= 37.0 degrees C.

1. Patients with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history, 2. Those who are allergic to any component of the vaccine, and those who have had any history of severe allergy to the vaccine (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain), 3. Patients with immunodeficiency, cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or close family members with congenital immune diseases, 4. Subjects injected with non-specific immunoglobulin within one month before enrollment, 5. Severe liver and kidney diseases, respiratory system diseases, cardiovascular diseases, malignant tumors, patients with uncontrollable diabetic complications, acute attack of various acute or chronic diseases, various infectious, suppurative and allergic skin diseases, 6. Subjects injected with non-specific immunoglobulin within one month before enrollment, 7. Subjects with acute febrile diseases and infectious diseases whose body temperature is more than 37.0 degrees C, 8. Pregnant or lactating women.

3

Shanxi Center for Disease Control and Prevention

18

59

China

Healthy volunteers

N/A

360

Serum neutralizing antibodies; IgG antibodies; and IgM antibodies of SARS-CoV-2 28 days after the last dose of vaccination;

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 0

[{"arm_notes": "2;days 0-14", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;days 0-21", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;days 0-28", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]