Status:
UNKNOWN
Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of thi...
Detailed Description
This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine，to compare the similarities and differences of imm...
Eligibility Criteria
Inclusion
- Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
- The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
- Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
- Proven legal identity;
Exclusion
- 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;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
- Pregnancy or lactation;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05329038
Start Date
April 19 2022
End Date
February 20 2024
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rushan City Center for Disease Control and Prevention
Weihai, Shandong, China, 250014