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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05003466
• Other study ID #: 2020L001-2B
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2021
• Est. completion date: April 2023

Study information

• Verified date: August 2021
• Source: Shenzhen Kangtai Biological Products Co., LTD
• Contact: Guifan Li, M.S
• Phone: +861059613591
• Email: liguifan[@]biominhai.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Hunan Provincial Center for Diseases Control and Prevention	Changsha	Hunan

Sponsors (3)

Lead Sponsor	Collaborator
Shenzhen Kangtai Biological Products Co., LTD	Beijing Minhai Biotechnology Co., Ltd, Hunan Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

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