Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

Inclusion Criteria:

1. Clinically healthy children aged 12-17 years.
2. Parent and/or legal guardian has been informed properly regarding the study and signedthe informed consent form (and assent for subjects aged 12-17 years).
3. Parent and/or legal guardian will commit to comply with the instructions of theinvestigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any COVID-19 vaccine (based on anamnesis).
3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. History of asthma, history of allergy to vaccines or vaccine ingredients, and severeadverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscularinjection.
7. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolledhypertension and diabetes, liver and kidney diseases, malignant tumors, etc) whichaccording to the investigator might interfere with the assessment of the trialobjectives.
8. Subjects who have any history of confirmed or suspected immunosuppressive orimmunodeficient state, or received in the previous 4 weeks a treatment likely to alterthe immune response (intravenous immunoglobulins, blood-derived products or long-termcorticosteroid therapy (> 2 weeks)).
9. Subjects who have history of uncontrolled epilepsy or other progressive neurologicaldisorders, such as Guillain-Barre Syndrome.
10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month beforeand after IP immunization.
11. Female who are pregnant or planning to become pregnant during the study period (judgedby self-report of subjects and urine pregnancy test results).
12. Subjects plan to move from the study area before the end of study period.