Status:
COMPLETED
Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine 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 the investigational SCB-2019 vaccine, administered as a booster dose, to adults who: * Received primary series with one of the ...
Eligibility Criteria
Inclusion
- Male and female participants at least 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 primary vaccination series with one of the selected COVID-19 vaccines (Comirnaty, Vaxzevria, or CoronaVac) ≥3 months prior to enrollment; or received primary series and a booster dose (≥3 months after primary series) of CoronaVac, ≥3 months prior to enrollment.
Exclusion
- Individuals with fever \>37.5°C (axillary), or any acute illness at baseline (Day 1) or within 3 days prior to randomization;
- Individuals with laboratory-confirmed SARS-CoV-2 infection at Visit 1 (determined by positive Rapid Antigen Test or RT-PCR);
- Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for primary series with Comirnaty, Vaxzevria, CoronaVac vaccines, or primary and booster dose of CoronaVac), or plan to receive COVID-19 vaccine during the study period;
- Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines;
- Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2023
Estimated Enrollment :
1831 Patients enrolled
Trial Details
Trial ID
NCT05188677
Start Date
June 13 2022
End Date
June 6 2023
Last Update
August 24 2023
Active Locations (2)
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1
Las Piñas Doctors Hospital
Las Piñas, National Capital Region, Philippines, 1741
2
Manila Doctors Hospital
Manila, National Capital Region, Philippines, 1000