Clinical Trial of SARS-CoV-2 Vaccine (Vero Cells), Inactivated in Healthy Population Aged 3 to 17 Years(COVID-19)

Shenzhen Kangtai Biological Products

Status and phase

Unknown

Phase 1

Conditions

COVID-19

Treatments

Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated

Biological: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05003479

2020L001-2A

Details and patient eligibility

About

This study is a randomized, double-blinded, and placebo controlled phase Ⅰ 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.

Enrollment

84 estimated patients

Sex

All

Ages

3 to 17 years old

Volunteers

Accepts Healthy Volunteers

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
With abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration;
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.