This study is a randomized, double-blinded, and placebo controlled phase Ⅱ clinical trial of the SARS-CoV-2 inactivated vaccine to evaluate the safety and immunogenicity of the experimental vaccine in healthy population aged 3 to 17 years.
Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated
2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose.
Administer as an intramuscular injection into the lateral deltoid of the upper arm.
Biological: Placebo
2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
Inclusion Criteria:
- Healthy residents aged 3 to 17 years at the time of consent
- Subjects and/or their guardian agree to sign the informed consent forms voluntarily.
- Be able to comply with study requirements/procedures.
- Axillary temperature ≤ 37.0℃
Exclusion Criteria:
- 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;
- History of vaccination of various COVID-19 vaccines or positive in SARS-CoV-2 antibody
test;
- Positive urine pregnancy test for females with menarche
- 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;
- History or family history of convulsion, epilepsy, encephalopathy or mental illness;
- 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, drug-uncontrollable
hypertension, diabetic complications, malignant tumors, various acute diseases or
acute onset of chronic diseases;
- Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma,
leukemia or other autoimmune diseases;
- 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.
Hunan Provincial Center for Diseases Control and Prevention
Changsha, Hunan, China
Investigator: Tao Huang
Contact: +8673184305935
ymlc01@hncdc.com
Guifan Li, M.S
+861059613591
liguifan@biominhai.com