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

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ClinicalTrials.gov Identifier: NCT04911790
Recruitment Status : Recruiting
First Posted : June 3, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Experimental Group Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 121000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 18 Years and Older: A Multicenter,Open-label Study
Actual Study Start Date : June 5, 2021
Estimated Primary Completion Date : September 5, 2021
Estimated Study Completion Date : December 31, 2022

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 Name: CoronaVac




Primary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-7 after each dose vaccination ]
    Incidence rate of adverse reactions within 0~7 days after each dose in all populations.


Secondary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-7 after each dose vaccination ]
    Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.

  2. Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence rate of adverse reactions within 0~28 days after each dose in all populations.

  3. Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions within 0~28 days after each dose in the population with pre-existing disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04911790


Contacts
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Contact: Xiaoqiang Liu, Doctor 15911568282 lxq7611@126.com

Locations
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China, Yunnan
Yongping Center for Diseases Control and Prevention Recruiting
Dali, Yunnan, China, 650022
Contact: XiaoQiang Liu       lxq7611@126.com   
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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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: Dongjuan Zhang Fujian Provincial Center for Disease Control and Prevention
Principal Investigator: Shicheng Guo Jiangxi Provincial Center for Disease Control and Prevention
Principal Investigator: Yeqing Tong Hubei 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: Ruizhi Zhang Guizhou Provincial Center for Disease Control and Prevention
Principal Investigator: Xiaoshu Zhang Gansu Provincial Center for Disease Control and Prevention
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04911790    
Other Study ID Numbers: PRO-nCOV-MA4002
First Posted: June 3, 2021    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No