Status:
UNKNOWN
Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Hubei Provincial Center for Disease Control and Prevention
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 6 months since finished t...
Eligibility Criteria
Inclusion
- Axillary temperature ≤37.0 ℃.
- aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
- 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
- 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.
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05216484
Start Date
February 18 2022
End Date
December 30 2022
Last Update
May 23 2022
Active Locations (1)
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1
Xiangyang City Centers for Disease Control and Prevention
Xiangyang, Hubei, China, 441022