Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of the Third Dose Using Inactivated COVID-19 Vaccine in Population Aged 18 Years and Above

PRO-nCOV-MA4009-SD

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 this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.

2022-04-19

2022-06-19

2024-02-20

Active (not recruiting)

Early phase I

180

Inclusion Criteria: * 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 Criteria: * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 180, 'type': 'ESTIMATED'}}

2023-11-07