Immunogenicity and Safety of a Third Dose of COVID-19 Vaccine(Vero Cell), Inactivated in the Elderly
- Conditions
- COVID-19
- Interventions
- Biological: COVID-19 Vaccine (Vero cell), Inactivated
- Registration Number
- NCT05398926
- Lead Sponsor
- Sinovac Life Sciences Co., Ltd.
- Brief Summary
This is an open phase Ⅲ clinical trial of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated in the Elderly Aged 60 years and above.
- Detailed Description
This study is an open phase Ⅲ clinical trial. The main purpose of this study is to evaluate Immunogenicity and safety of a third dose at different times after two-dose of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd. in the elderly aged 60 years and above.A total of 400 subjects aged 60 years and above who had received two doses of COVID-19 vaccine(Vero Cell), inactivated manufactured by Sinovac Research \& Development Co., Ltd. between 3 - 6 months ago (100 subjects for 3 months, 4 months, 5 months and 6 months,respectively) will be enrolled and receive a third dose of two-dose of COVID-19 vaccine (Vero cell), inactivated were enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- Subjects aged 60 years and above;
- Provide legal identification;
- Have completed two-dose of COVID-19 vaccine (Vero cell), inactivated manufactured by Sinovac Research& Development Co., Ltd. for 3~6 months（The interval between two doses was 21~35 days）；
- Be able to understand and voluntarily sign the informed consent form and be willing to complete the study according to the research plan.
- History of SARS-CoV-2 infection(laboratory confirmed);
- Those who have received COVID-19 vaccine from other manufacturers other than Sinovac Research& Development Co., Ltd., or who have received booster immunization with COVID-19 vaccine after two doses of COVID-19 vaccine (Vero cell),inactivated manufactured by Sinovac Research& Development Co., Ltd.;
- History of serious adverse reactions to the vaccine or vaccine components, such as urticaria dyspnea and angioneuroedema;
- 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) in the past 6 months or plan to receive these treatments during the study period;
- Receipt of blood products within in the past 3 months or plan to receive these treatments during the study period;
- Receipt of other investigational drugs in the past 30 days;
- Receipt of attenuated live vaccines in the past 14 days,or receipt of inactivated or subunit vaccines in the past 7 days;
- Onset of various acute or chronic diseases within 7 days prior to the study;
- Axillary temperature >37.0°C;
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group 3 (5-month interval) COVID-19 Vaccine (Vero cell), Inactivated 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (5-month interval）. Experimental group 1 (3-month interval) COVID-19 Vaccine (Vero cell), Inactivated 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (3-month interval）. Experimental group 2 (4-month interval) COVID-19 Vaccine (Vero cell), Inactivated 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (4-month interval）. Experimental group 4 (6-month interval) COVID-19 Vaccine (Vero cell), Inactivated 100 subjects who have received two doses of COVID-19 vaccine (Vero cell), Inactivated will receive a 3rd dose of the vaccine (6-month interval）.
- Primary Outcome Measures
Name Time Method Immunogenicity index-GMT of neutralizing antibodies At 14 days after vaccination GMT of neutralizing antibodies at 14 days after vaccination
Immunogenicity index- GMT of neutralizing antibodies At 28 days after vaccination GMT of neutralizing antibodies at 28 days after vaccination
Safety index-Incidence of adverse reactions 0~28 days after vaccination Incidence of adverse reactions 0\~28 days after vaccination
- Secondary Outcome Measures
Name Time Method Immunogenicity index-GMT of neutralizing antibodies Day 0 before vaccination and 180 days after vaccination GMT of neutralizing antibodies before vaccination and at different points after vaccination.
Immunogenicity index-4-fold increase rate of neutralizing antibodies At 14 days and 28 days after vaccination. 4-fold increase rate of neutralizing antibodies at different points after vaccination.
Safety index-Incidence of adverse reactions 0~7 days after vaccination Incidence of adverse reactions 0\~7 days after vaccination.
Immunogenicity index-seropositive rate of neutralizing antibodies Day 0 before vaccination and 14 days, 28 days and 180 days after vaccination Seropositive rate of neutralizing antibodies of neutralizing antibodies before vaccination and at different points after vaccination
Safety index-Incidence of serious adverse events 6 months after vaccination Incidence of serious adverse events 6 months after vaccination.
Trial Locations
- Locations (1)
Yongde Center for Diseases Control and Prevention
🇨🇳Lincang, Yunnan, China