Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
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ClinicalTrials.gov Identifier: NCT04894227 |
Recruitment Status :
Completed
First Posted : May 20, 2021
Last Update Posted : April 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1080 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac) in Health Adults Aged 26-45 Years |
Actual Study Start Date : | May 11, 2021 |
Actual Primary Completion Date : | May 11, 2021 |
Actual Study Completion Date : | November 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Inactivated SARS-CoV-2 vaccine Lot 1
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.
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Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac |
Experimental: Inactivated SARS-CoV-2 vaccine Lot 2
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.
|
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac |
Experimental: Inactivated SARS-CoV-2 vaccine Lot 3
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.
|
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac |
- Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
- Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
- GMT of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
- Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population
- Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
- Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
- GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population
- Seropositivity rate of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
- Seroconversion rate of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
- Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
- GMI of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose
- Incidence of adverse reactions after vaccination [ Time Frame: From the beginning of the vaccination to 28 days after the second dose ]Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose

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Ages Eligible for Study: | 26 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adults aged 26-45;
- The subjects can understand and voluntarily sign the informed consent form ;
- Proven legal identity.
Exclusion Criteria:
- Travel history / residence history of communities with case reports within 14 days prior to the study;
- History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
- Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
- Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days prior to the study;
- History of SARS-CoV-2 infection or receiving COVID-19 vaccine;
- 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;
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
- Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
- 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;
- Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
- 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;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- Axillary temperature >37.0°C;
- Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
- The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

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): NCT04894227
China, Jiangsu | |
Jingliang Wu | |
Huai'an, Jiangsu, China, 223300 |
Principal Investigator: | Hongxing Pan, Master | Jiangsu Provincial Center for Disease Prevention and Control |
Responsible Party: | Sinovac Research and Development Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04894227 |
Other Study ID Numbers: |
PRO-nCOV-4001 |
First Posted: | May 20, 2021 Key Record Dates |
Last Update Posted: | April 13, 2022 |
Last Verified: | May 2021 |
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 |