About this trial
A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity
Eligibility criteria
Qualifiers
Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
Basic or booster immunization with COVID-19 vaccine ≥6 months.
≥3 months of SARS-CoV-2 infection history, or never infected.
Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.
Disqualifiers
Axillary temperature ≥37.3℃.
SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
It is in the advanced stage of malignant tumor and the disease control is unstable.
Trial design
Treatments tested in this trial
- High dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)
- Low dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)
- control group
- Placebo group