COVID-19Phase 4NCT04911790
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults
A Phase 4 study testing Experimental Group in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.
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 18 years years and older and in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Experimental Group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131,650 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2021to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Yongping Center for Diseases Control and Prevention
Dali, Yunnan, 650022
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Experimental Group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupBiological
Also called CoronaVac
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participant will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. Receives: Biological: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 0~7 days after each dose in all populations.
Measured: Day 0-7 after each dose vaccination
Secondary outcomes (3)
Safety index-incidence of adverse reactions
Incidence of adverse reactions within 0~7 days after each dose in the population with pre-existing disease.
Measured: 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.
Measured: 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.
Measured: Day 0-28 after each dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start5 Jun 2021
- Primary completion2 Jan 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Research and Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Liu, Doctor, Principal investigator, Yunnan Center for Disease Control and PreventionXing Fang, Principal investigator, Liaoning Provincial Center for Disease Control and PreventionZhaodan Sun, Principal investigator, HeilongjiangProvincial Center for Disease Control and PreventionFubing Wang, Principal investigator, Hefei Provincial Center for Disease Control and PreventionDongjuan Zhang, Principal investigator, Center for Disease Control and Prevention, FujianShicheng Guo, Principal investigator, Jiangxi Provincial Center for Disease Control and PreventionYeqing Tong, Principal investigator, Hubei Provincial Center for Disease Control and PreventionQiuyun Deng, Principal investigator, Guangxi Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911790
- Sponsor's protocol ID
- PRO-nCOV-MA4002
- Status last verified
- May 2021
- First submitted
- 2 Jun 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang H, Li Z, Zhang R, Guo S, Wang B, Fang X, Zhang D, Zhang X, Tong Y, Wang Q, Deng Q, Sun Z, Liu X, Gao Y. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac(R)) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China. Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13.
PubMed 36658045
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04911790
- Acronym / sponsor ID
- PRO-nCOV-MA4002
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131,650 participants (actual)
- Lead sponsor
- Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Experimental GroupParticipant will receive two doses inactivated SARS-CoV-2 vaccine . Vaccine will given by intramuscular injection on day 0 and day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental GroupAlso: CoronaVacSARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection | Biological | Experimental Group |
Primary outcome
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.
3 secondary outcomes
Safety index-incidence of adverse reactions
Time frame: Day 0-7 after each dose vaccination
Safety index-incidence of adverse reactions
Time frame: Day 0-28 after each dose vaccination
Safety index-incidence of adverse reactions
Time frame: Day 0-28 after each dose vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 36658045Yang H, Li Z, Zhang R, Guo S, Wang B, Fang X, Zhang D, Zhang X, Tong Y, Wang Q, Deng Q, Sun Z, Liu X, Gao Y. Safety of primary immunization using inactivated SARS-CoV-2 vaccine (CoronaVac(R)) among population aged 3 years and older in a large-scale use: A multi-center open-label study in China. Vaccine. 2023 Feb 10;41(7):1354-1361. doi: 10.1016/j.vaccine.2023.01.020. Epub 2023 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoqiang Liu, Doctor principal investigator
Yunnan Center for Disease Control and Prevention
Xing Fang principal investigator
Liaoning Provincial Center for Disease Control and Prevention
Zhaodan Sun principal investigator
HeilongjiangProvincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Experimental Group in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety index-incidence of adverse reactions (time frame: Day 0-7 after each dose vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.