Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04911790 |
Recruitment Status :
Recruiting
First Posted : June 3, 2021
Last Update Posted : October 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Biological: Experimental Group | Phase 4 |
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 |
Actual Primary Completion Date : | October 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.
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Biological: Experimental Group
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Other Name: CoronaVac |
- 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.
- 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.
- 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.
- 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 |
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.

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
Contact: Xiaoqiang Liu, Doctor | 15911568282 | lxq7611@126.com |
China, Yunnan | |
Yongping Center for Diseases Control and Prevention | Recruiting |
Dali, Yunnan, China, 650022 | |
Contact: XiaoQiang Liu lxq7611@126.com |
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 | Center for Disease Control and Prevention, Fujian | |
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 |
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: | October 29, 2021 |
Last Verified: | May 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |