Clinical trial NCT05003466: Study of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 3 to 17 Years(COVID-19)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Shenzhen Kangtai Biological Products Co., LTD
Sponsor class: INDUSTRY
Collaborators: name: Beijing Minhai Biotechnology Co., Ltd
name: Hunan Provincial Center for Disease Control and Prevention
First posted: 2021-08-12
Enrollment: 480
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Seroconversion rate of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days post full primary immunization course
measure: Geometric mean titer of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days post full primary immunization course
Secondary outcomes:
measure: Incidence of adverse reactions/events
timeFrame: 0-28 days after each vaccination
measure: Serious Adverse Events (SAE)
timeFrame: within 12 months post full primary immunization course and the booster dose respectively
measure: Seroconversion rate of SARS-CoV-2 IgG binding antibody
timeFrame: 28 days post full primary immunization course
measure: Geometric mean titer of SARS-CoV-2 IgG binding antibody
timeFrame: 28 days, 3 months, 6 months and 12 months post full primary immunization course
measure: Geometric mean titer of SARS-CoV-2 IgG binding antibody
timeFrame: 28 days, 3 months, 6 months and 12 months after the booster dose
measure: Geometric mean titer of SARS-CoV-2 neutralizing antibody
timeFrame: 3 months, 6 months and 12 months post full primary immunization course
measure: Geometric mean titer of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days, 3 months, 6 months and 12 months after the booster dose
measure: Seropositive rate of SARS-CoV-2 neutralizing antibody
timeFrame: 3 months, 6 months and 12 months post full primary immunization course
measure: Seropositive rate of SARS-CoV-2 neutralizing antibody
timeFrame: 28 days, 3 months, 6 months and 12 months after the booster dose
measure: Seropositive rate of SARS-CoV-2 IgG binding antibody
timeFrame: 3 months, 6 months and 12 months post full primary immunization course
measure: Seropositive rate of SARS-CoV-2 IgG binding antibody
timeFrame: 28 days, 3 months, 6 months and 12 months after the booster dose
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial Center for Diseases Control and Prevention
state: Hunan
Study officials:
References: