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

Phase 2

• Conditions: COVID-19
• Interventions: Biological: Placebo; Biological: SARS-CoV-2 Vaccine (Vero Cells), Inactivated

• Registration Number: NCT05003466
• Lead Sponsor: Shenzhen Kangtai Biological Products Co., LTD

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-18
• Study Start: 2021-09
• Primary Completion: 2023-03
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
candidate vaccine	SARS-CoV-2 Vaccine (Vero Cells), Inactivated	-

Primary Outcome Measures

Name	Time	Method
Seroconversion rate of SARS-CoV-2 neutralizing antibody	28 days post full primary immunization course
Geometric mean titer of SARS-CoV-2 neutralizing antibody	28 days post full primary immunization course

Secondary Outcome Measures

Name	Time	Method
Seroconversion rate of SARS-CoV-2 IgG binding antibody	28 days post full primary immunization course
Geometric mean titer of SARS-CoV-2 IgG binding antibody	28 days, 3 months, 6 months and 12 months after the booster dose
Incidence of adverse reactions/events	0-28 days after each vaccination
Serious Adverse Events (SAE)	within 12 months post full primary immunization course and the booster dose respectively
Geometric mean titer of SARS-CoV-2 neutralizing antibody	28 days, 3 months, 6 months and 12 months after the booster dose
Seropositive rate of SARS-CoV-2 neutralizing antibody	28 days, 3 months, 6 months and 12 months after the booster dose
Seropositive rate of SARS-CoV-2 IgG binding antibody	28 days, 3 months, 6 months and 12 months after the booster dose

Trial Locations

Locations (1)

Hunan Provincial Center for Diseases Control and Prevention; 🇨🇳 Changsha, Hunan, China