Status:
WITHDRAWN
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
Lead Sponsor:
Clover Biopharmaceuticals AUS Pty
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 wi...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06567457
Start Date
October 1 2023
End Date
October 1 2024
Last Update
August 22 2024
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