The purpose of this study is to assess the immunogenicity and safety of SCB-2023Bmonovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine inparticipants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 monthsprior to enrollment.
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B
monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in
participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months
prior to enrollment.
Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
intramuscular injection
Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
intramuscular injection
Inclusion Criteria:
- Male or female ≥18 years of age.
- Individuals willing and able to comply with study requirements, including all
scheduled visits, vaccinations, laboratory tests and other study procedures.
- Individuals willing and able to give an informed consent, prior to screening.
- Healthy participants or participants with pre-existing medical conditions who are in
a stable medical condition.
- Individuals who received three doses of inactivated COVID-19 vaccine
Exclusion Criteria:
- Body temperature >37.8°C (axillary), or any acute illness at baseline.
- Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
- Individuals who have received an investigational or licensed COVID-19 vaccine prior
to Day 1 (except for inactivated COVID-19 vaccine).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting
from disease or immunosuppressive/cytotoxic therapy.
- Any progressive unstable or uncontrolled clinical conditions.
- Individuals who are pregnant, or breastfeeding, or planning to become pregnant while
enrolled in this study or during the study period.
- History of severe adverse reaction associated with a vaccine or severe allergic
reaction.
- History of malignancy within 1 year before screening.
- Individuals who have received any other investigational product.
- Individuals who have received any other licensed vaccines within 14 days prior to
enrollment.
- Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
- Known bleeding disorder that would, in the opinion of the investigator,
contraindicate i.m. injection.
- Administration of intravenous immunoglobulins and/or any blood products.
- Any condition that, in the opinion of the investigator, would interfere with the
primary study objectives or pose additional risk to the participant.
Not Provided
Not Provided