This is a phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trialof 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-immuneresponse of booster immunization using COVID-19 vaccine,to compare the similarities anddifferences of immune responses between primary immunization and booster immunization andto detect antibody against hepatitis A and evaluate the immune persistence of the onedose immunization schedule of hepatitis A vaccine in healthy population aged 18 years andolder.
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 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. The experimental vaccine is manufactured by Sinovac
Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated
COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical
trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged
60 years and older.Subjects in each age group will receive the booster immunization of
CoronaVac(the third dose) and will be collected blood sample before booster immunization
and 14 days after booster immunization.
Biological: Inactivated COVID-19 Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
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.
Rushan City Center for Disease Control and Prevention
Weihai, Shandong, China
Li Zhang, Master, Principal Investigator
Shandong Provincial Center for Disease Control and Prevention