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COVID-19Phase 4NCT04953325

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

A Phase 4 study testing Inactivated COVID-19 Vaccine, 23-valent pneumococcal polysaccharide vaccine and Inactivated Hepatitis A Vaccine in people with COVID-19, run by Sinovac Research and Development Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. 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?
Inactivated COVID-19 Vaccine, 23-valent pneumococcal polysaccharide vaccine and Inactivated Hepatitis A Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
1 siteChina
Study dates
9 Jul 2021to 31 Jan 2022
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

  • Healthy population aged 18 years and above;
  • The subjects can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Who cannot join

  • History of SARS-CoV-2 infection;
  • Have received any COVID-19 vaccine;
  • Participants with abnormal fasting blood glucose or diabetes;
  • History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
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  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, May-Thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • Abnormal hematological laboratory test results outside the reference range during previous physical examination within one year: Blood routine indicators (white blood cell count, hemoglobin, platelet count), Coagulation function test (prothrombin time PT, activated partial prothrombin time APTT, fibrinogen FIB, thrombin time TT, international standardized ratio INR, D-dimer), other indicators (blood glucose, platelet factor 4 HIT ELISA, erythrocyte sedimentation rate);
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
  • History of taking aspirin drugs and other drugs that affect blood coagulation;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Rushan City Center for Disease Control and Prevention

    Weihai, Shandong, 250014

Other trials in China

About this study

Official title: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Healthy Population Aged 18 Years and Older

This study is a randomized, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Read the detailed description

This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac）in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.

Conditions
COVID-19
Being tested
Inactivated COVID-19 Vaccine, 23-valent pneumococcal polysaccharide vaccine, Inactivated Hepatitis A Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inactivated COVID-19 VaccineBiological

    Also called CoronaVac

    600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection

  • 23-valent pneumococcal polysaccharide vaccineBiological

    25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F

  • Inactivated Hepatitis A VaccineBiological

    500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.

Study groups in NCT04953325
Study groupRoleWhat they receive
Experimental GroupExperimental180 subjects (including 90 adults aged 18-59 years and 90 elderly aged 60 year and older）will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28
Receives: Biological: Inactivated COVID-19 Vaccine
Control GroupPlacebo comparator90 subjects (including 45 adults aged 18-59 years and 45 elderly aged 60 year and older）will receive one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28
Receives: Biological: 23-valent pneumococcal polysaccharide vaccine; Biological: Inactivated Hepatitis A Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Seroconversion rate of the neutralizing antibody to SARS-CoV-2

    Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine

    Measured: Day 28 after the second dose

Secondary outcomes (11)

  1. Seroconversion rate of the neutralizing antibody to SARS-CoV-2

    Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

    Measured: Day 4, 14, 32,42 and 56 after the first dose

  2. Seropositivity rate of the neutralizing antibody to SARS-CoV-2

    Seropositivity rate of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

    Measured: Day 4, 14, 28, 32,42 and 56 after the first dose

  3. GMT of the neutralizing antibody to SARS-CoV-2

    GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

    Measured: Day 4, 14, 28, 32,42 and 56 after the first dose

  4. GMI of the neutralizing antibody to SARS-CoV-2

    GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

    Measured: Day 4, 14, 28, 32,42 and 56 after the first dose

  5. Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA)

    Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

    Measured: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

  6. Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA)

    Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

    Measured: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

  7. Seroconversion rate of the hepatitis A antibody by Electrochemiluminescence

    Seroconversion rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

    Measured: Day 28 after vaccination of Inactivated Hepatitis A Vaccine

  8. Seropositivity rate of the hepatitis A antibody by Electrochemiluminescence

    Seropositivity rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

    Measured: Day 28 after vaccination of Inactivated Hepatitis A Vaccine

  9. GMT of the hepatitis A antibody by Electrochemiluminescence

    GMT of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

    Measured: Day 28 after vaccination of Inactivated Hepatitis A Vaccine

  10. GMI of the hepatitis A antibody by Electrochemiluminescence

    GMI of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

    Measured: Day 28 after vaccination of Inactivated Hepatitis A Vaccine

  11. Occurrence of abnormal changes of laboratory safety examinations

    Occurrence of abnormal changes of laboratory safety examinations (Platelet factor 4 HIT, blood sugar, ESR, White blood cell count, hemoglobin, platelet count and Coagulation function index)

    Measured: Day 4, 14, 28, 32,42 and 56 after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study start9 Jul 2021
  3. Primary completion31 Oct 2021
  4. Study completion31 Jan 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04953325
Sponsor's protocol ID
PRO-nCOV-MA4004-SD
Status last verified
Jul 2021
First submitted
5 Jul 2021
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu Q, Lu X, Liu X, Zhao Y, Sun D, Cao Q, Liu H, Yang T, Song Y, Lv J, Xiong P, Li J, Sun J, Xie M, Gao Y, Zhang L. Effect of an inactivated coronavirus disease 2019 vaccine, CoronaVac, on blood coagulation and glucose: a randomized, controlled, open-label phase IV clinical trial. Front Immunol. 2023 May 31;14:1122651. doi: 10.3389/fimmu.2023.1122651. eCollection 2023.

    PubMed 37325662

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Inactivated COVID-19 Vaccine, 23-valent pneumococcal polysaccharide vaccine and Inactivated Hepatitis A Vaccine 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 21 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 14 Apr 2022. 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. Some participants in this study may receive a placebo. 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?

Seroconversion rate of the neutralizing antibody to SARS-CoV-2 (time frame: Day 28 after the second dose). 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 NCT04953325, 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 14 Apr 2022.

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