Official Title
A Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years
Brief Summary

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.

Not yet recruiting
COVID-19

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 3 Years ~ Maximum: 17 Years
Countries
China
Locations

Hunan Provincial Center for Diseases Control and Prevention
Changsha, Hunan, China

Investigator: Tao Huang
Contact: +8673184305935
ymlc01@hncdc.com

Contacts

Guifan Li, M.S
+861059613591
liguifan@biominhai.com

Shenzhen Kangtai Biological Products Co., LTD
NCT Number
MeSH Terms
COVID-19