Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults

Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 18 Years and Older: A Multicenter,Open-label Study

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 18 years years and older and in people with pre-existing disease to provide reference for improving the immunization strategy of COVID-19 vaccine.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: Experimental Group

Detailed Description

This study is a multi-center and open design, phase Ⅳ clinical trial in population aged 18 years years and older. 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 May 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 121000 subjects will be enrolled with11000 for each research center, including at least 2000 people with pre-existing disease and at least 4000 people in the elderly group (60 years old and above) (including patients with pre-existing disease).And subjects will receive two doses of vaccine on day 0 and day 28.

• Study Type: Interventional
• Enrollment (Actual): 131650
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Dali, Yunnan, China, 650022
      • Yongping Center for Diseases Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 18 years and above;
• 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 transverse myeliti,Guillain-Barre Syndrome and demyelinating disorders;
• Acute diseas,acute onset of chronic disease and severe chronic diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participant will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28.	Biological: Experimental Group; SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection; Other Names: CoronaVac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-incidence of adverse reactions	Incidence rate of adverse reactions within 0~7 days after each dose in all populations.	Day 0-7 after each dose vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety index-incidence of adverse reactions	Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.	Day 0-7 after each dose vaccination
Safety index-incidence of adverse reactions	Incidence rate of adverse reactions within 0~28 days after each dose in all populations.	Day 0-28 after each dose vaccination
Safety index-incidence of adverse reactions	Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.	Day 0-28 after each dose vaccination

Collaborators and Investigators

• Sponsor: Sinovac Research and Development Co., Ltd.
• Investigators: Principal Investigator: Xiaoqiang Liu, Doctor, Yunnan Provincial Center for Disease Control and Prevention; Principal Investigator: Xing Fang, Liaoning Provincial Center for Disease Control and Prevention; Principal Investigator: Zhaodan Sun, HeilongjiangProvincial Center for Disease Control and Prevention; Principal Investigator: Fubing Wang, Hefei Provincial Center for Disease Control and Prevention; Principal Investigator: Shicheng Guo, Jiangxi Provincial Center for Disease Control and Prevention; Principal Investigator: Qiuyun Deng, Guangxi Center for Disease Control and Prevention; Principal Investigator: Qing Wang, Chongqing Center for Disease Control and Prevention; Principal Investigator: Xiaoshu Zhang, Gansu provincial center for disease control and prevention; Principal Investigator: Dongjuan Zhang, Center for Disease Control and Prevention, Fujian; Principal Investigator: Yeqing Tong, Hubei Provincial Center for Disease Control and Prevention; Principal Investigator: Ruizhi Zhang, Guizhou Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2021
• Primary Completion (Actual): January 2, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PRO-nCOV-MA4002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No