phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The incidence rate of any adverse reactions/events
Timeframe: within 30 minutes after vaccination
The incidence severity of any adverse reactions/events
Timeframe: within 30 minutes after vaccination
the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine
Timeframe: on the 4th day after each dose of vaccination
The incidence rate of solicited adverse reactions/events
Timeframe: within 0-7 days after vaccination
The incidence severity of solicited adverse reactions/events
Timeframe: within 0-7 days after vaccination
The incidence rate of solicited adverse reactions/events
Timeframe: within 8-30 days after vaccination
The incidence severity of solicited adverse reactions/events
Timeframe: within 8-30 days after vaccination
Incidence of adverse events leading to withdrawal
Timeframe: within 8-30 days after vaccination
Severity of adverse events leading to withdrawal
Timeframe: within 8-30 days after vaccination
The incidence of SAE observed
Timeframe: up to 12 months after full course of immunization
The incidence of AESI observed
Timeframe: up to 12 months after full course of immunization
Neutralizing antibody level against SARS-CoV-2 GMT
Timeframe: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 IgG antibody GMC
Timeframe: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 positive rate
Timeframe: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization
Neutralizing antibody level against SARS-CoV-2 Positive conversion rate
Timeframe: Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization