Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above
Phase 3
- Conditions
- SARS-CoV2 Infection
- Interventions
- Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
- Registration Number
- NCT05164731
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief Summary
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 880
Inclusion Criteria
- Axillary temperature ≤37.0 ℃.
- aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- Proven legal identity, could come each visit.
- Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
Exclusion Criteria
- Persons with a clear history of SARS-CoV-2 infection.
- Using blood products after basic immunization or receiving immunosuppressive therapy.
- Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
- Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
- History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
- Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- Immunization with any vaccine within 14 days.
- Any other situations judged by investigators as not suitable for participating in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 3 months after two doses SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 3 months after two doses 5 months after two doses SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 5 months after two doses 4 months after two doses SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 4 months after two doses 6 months after two doses SARS-CoV-2 Vaccine, Inactivated (Vero Cell) the third does was given 6 months after two doses
- Primary Outcome Measures
Name Time Method Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2 From 0 days to 6 month after the third dose Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
Adverse reactions/events rate 28 days after vaccination Occurence of adverse reactions/events after vaccination
SARS-CoV-2 specific memory B and T cell response From 0 days to 6 month after the third dose SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mile City Centers for Disease Control and Prevention
🇨🇳Mile, Yunnan, China