Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents

COVID-19 Clinical Trial

Official title:

Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04992208
• Other study ID #: PRO-nCOV-MA4008
• Status: Completed
• Phase: Phase 4
• Start date: July 24, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: August 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety of the SARS-CoV-2 Inactivated vaccine in population aged 3~17 years and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

Description:

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 3~17 years . The experimental vaccine will be manufactured by Sinovac Research and Development Co.,Ltd.The study is planned to be carried out in 11 provinces from August 2021 to December 2022, including Liaoning, Heilongjiang, Anhui, Fujian, Jiangxi, Hubei, Guangxi, Chongqing, Guizhou, Yunnan and Gansu. Each province will serve as a research center, and each research center will select the corresponding research site.A total of 33000 subjects including patients with pre-existing will be enrolled with 3000 for each research center, including 600 subjects aged 3~5years，1200 subjects aged 6~11 years,1200 subjects aged 12~17 years.

And subjects will receive two doses of vaccine on day 0 and day 28.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31041
• Est. completion date: August 31, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac manufactured by Sinovac Research and Development Co.,Ltd;

• Population aged 3~17 years ;

• The subjects can understand and voluntarily sign the informed consent form and participate in the follow-up;

Exclusion Criteria:

• History of severe allergy to the vaccine such as acute allergic reaction,angioedema and dyspnea ;

• Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and demyelinating disorders;

• Acute disease,acute onset of chronic disease and severe chronic diseases.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• Experimental Group
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

Locations

Country	Name	City	State
China	Yongping Center for Diseases Control and Prevention	Dali	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Life Sciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety index 1-incidence of adverse reactions	Incidence rate of adverse reactions within 0~7 days after each dose in all populations.	Within 0~7 days after each dose
Secondary	Safety index 2-incidence of adverse reactions	Incidence rate of adverse reactions within 0~28 days after each dose in all populations	Within 0-28 days after each dose vaccination
Secondary	Safety index 3-incidence of adverse reactions	Incidence of adverse reactions within 0~7 days after each dose in each age group	Within 0~7 days after each dose vaccination
Secondary	Safety index 4-incidence of adverse reactions	Incidence rate of adverse reactions within 0~28 days after each dose in each age group	Within 0~28 days after each dose vaccination
Secondary	Safety index 5-incidence of adverse reactions	Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.	Within 0~7 days after each dose vaccination
Secondary	Safety index 6-incidence of adverse reactions	Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.	Within 0~28 days after each dose vaccination