Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
1 other identifier
interventional
1,400
1 country
1
Brief Summary
This study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 covid19
Started Jun 2021
Shorter than P25 for phase_4 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2021
CompletedFirst Submitted
Initial submission to the registry
July 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2021
CompletedSeptember 24, 2021
June 1, 2021
2 months
July 13, 2021
September 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.
1 month after booster immunization
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
1 month after booster immunization
Secondary Outcomes (3)
Safety index-incidence of serious adverse events
1 month after booster immunization
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2
1 month after booster immunization
Seropositivity rate of IgG antibody
1 month after booster immunization
Study Arms (3)
Experimental Group
EXPERIMENTAL200 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.
Control Group
EXPERIMENTAL200 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.
Safety group
EXPERIMENTAL1000 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
Interventions
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Eligibility Criteria
You may qualify if:
- Healthy adults aged 18-59;
- 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.
You may not qualify if:
- History of SARS-CoV-2 infection;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Centers for Diseases Control and Prevention
Beijing, 100013, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiang Wu, Master
Beijing Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2021
First Posted
July 14, 2021
Study Start
June 19, 2021
Primary Completion
August 19, 2021
Study Completion
December 19, 2021
Last Updated
September 24, 2021
Record last verified: 2021-06