COVID-19
Conditions
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.
Interventions
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research& Development Co., Ltd.600SU inactivated SARS-CoV-2 CZ strain virus in 0.5 mL of aluminium hydroxide solution per injection.
Sponsors
Sinovac Life Sciences Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
China
Outcome results
None listed