A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅱb Clinical Trial, to Evaluate the Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 3 to 17 Years.

Sinovac Life Sciences Co., Ltd.1 site in 1 country500 target enrollmentMay 3, 2021

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Sinovac Life Sciences Co., Ltd.
Enrollment: 500
Locations: 1
Primary Endpoint: Safety index-incidence of adverse reactions
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a randomized, double-blinded, placebo-controlled, phase Ⅱb clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co. , Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in healthy children and adolescents aged 3-17 years.

Detailed Description

This study is a randomized, double-blinded, placebo-controlled,phase Ⅱb clinical trial in children and adolescents aged 3-17 years. The experimental vaccine and placebo were both manufactured by Sinovac Life Sciences Co. , Ltd. A total of 500 subjects will be enrolled, including 100 children aged 3-5 years, 200 children aged 6-11 years and 200 adolescents aged 12-17 years. Each age group will be randomly divided into two groups in a 3:1 ratio and received two doses of experimental vaccine or placebo on on day 0 and day 28.

Registry

clinicaltrials.gov

Start Date

May 3, 2021

End Date

June 20, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinovac Life Sciences Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy children and adolescents aged 3-17 years;
•The subjects and/or guardians can understand and voluntarily sign the informed consent form (For subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form);
•Proven legal identity.

Exclusion Criteria

•Travel history / residence history of communities with case reports within 14 days;
•History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
•Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days;
•Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
•History of SARS-CoV-2 infection;
•History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
•Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
•Autoimmune disease or immunodeficiency / immunosuppression;
•Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
•Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;

Outcomes

Primary Outcomes

Safety index-incidence of adverse reactions

Time Frame: Day 0-28 after each dose

Incidence rate of adverse reactions occured from the beginning of the vaccination to 28 days after the second dose.

Secondary Outcomes

Safety index-incidence of adverse reactions(Day 0-7 after each dose vaccination)
Safety index-incidence of serious adverse events(From the beginning of the vaccination to 6 months after the second dose vaccination)