Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
NCT ID: NCT04962308
Last Updated: 2021-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1400 participants
INTERVENTIONAL
2021-06-19
2021-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Group
200 subjects in group A1 will receive one dose of booster immunization 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.
SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Control Group
200 subjects in group A2 will receive one dose of booster immunization 5 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.
The SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Safety group
1000 subjects in group B will be enrolled and receive 1 dose of booster immunization more than 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine
SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Interventions
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SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
The SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd for group B;
* The subjects can understand and voluntarily sign the informed consent form;
* Proven legal identity.
Exclusion Criteria
* Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
* Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
* 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;
* Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization;
* Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
* Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
* Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
* Axillary temperature \>37.0°C prior to booster vaccination;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
18 Years
59 Years
ALL
Yes
Sponsors
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Sinovac Research and Development Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jiang Wu, Master
Role: PRINCIPAL_INVESTIGATOR
Beijing Center for Disease Control and Prevention
Locations
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Beijing Centers for Diseases Control and Prevention
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PRO-nCOV-4003
Identifier Type: -
Identifier Source: org_study_id
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