A randomized, double-blind, placebo-controlled international multicenter clinical trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.
After signing the informed consent form, the volunteers aged 18 years and above will receive the relevant examinations after an inquiry by investigator of the medical history (including COVID-19 history), recent medication(vaccine) history, allergy history and concomitant medications, and demographic data collection by the investigators, including physical examination (skin and mucous membranes, lymph nodes, head, neck, chest, abdomen, spine/limbs), novel Coronavirus (SARS-COV-2) nucleic acid test and antibody test, urine pregnancy (women of childbearing age) test, and vital signs (blood pressure, axillary/oral temperature, pulse) evaluation. Screening eligible subjects will be 1:1 randomly assigned to the experimental group and the placebo control group, and vaccinated as per the 0, 1, 2 month immunization schedule. All adverse events (AEs) up to 30 minutes after each dose of vaccination, all AEs from 0 to 7 days (including both solicited and unsolicited), and all AES from 8 to 30 days (unsolicited) will be collected; All serious adverse events (SAEs) will be collected from the first dose of vaccination to 12 months after the whole vaccination. The incidence rate and efficacy of any severity of COVID-9 of any severity 14 days after whole vaccination. Blood samples (5ml) will be collected before the first dose of vaccination and 14 days and 6 months after the whole course of vaccination to detect neutralizing antibody of SARS-COV-2 and protein binding antibody IgG of receptor binding region (RBD) .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
28,904
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Biodimed Guayaquil Clinical Research Center
Guayaquil, Guayas, Ecuador
Biodimed Alemania Clinical Research Center
Quito, Pichincha, Ecuador
Biodimed Eloy Alfaro Clinical Research Center
Quito, Pichincha, Ecuador
Fkui-Rscm
Jakarta, Jakarta Special Capital Region, Indonesia
FK Unpad/RSHS
Bandung, West Java, Indonesia
Aziz Fatimah Hospital
Faisalabad, Punjab Province, Pakistan
Avicenna Hospital
Lahore, Punjab Province, Pakistan
Central Park Teaching Hospital
Lahore, Punjab Province, Pakistan
National Hospital & Medical Center
Lahore, Punjab Province, Pakistan
...and 8 more locations
The endpoint of efficacy study
The number of any severity of COVID-9 cases 14 days after whole vaccination
Time frame: 14 days to one year after whole vaccination
The endpoint of safety study
Analysis of adverse events from the first dose of vaccination until 30 days after full course of vaccination
Time frame: From the first dose of vaccination until 30 days after full course of vaccination
The endpoint of safety study
Analysis of serious adverse events from the first dose of vaccination until 12 months after full course of vaccination
Time frame: From the first dose of vaccination until 12 months after full course of vaccination
The endpoint of efficacy study
The number of severe and severity above COVID-19 cases 14 days after whole vaccination; The number of any severity of COVID-9 cases after first dose of vaccination; The number of COVID-19 cases of any severity in populations of different age group (18-59 years vs. 60 years and above) 14 days after whole vaccination.
Time frame: Up to one year after the vaccination
Endpoint of immunogenicity and immune persistence study
The level of neutralizing antibody to SARS-COV-2 and IgG level of RBD protein binding antibody at 14 days and 6 months after full course of vaccination.
Time frame: At 14 days and 6 months after full course of vaccination
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