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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
intramuscular injection
intramuscular injection
GMT ratio
Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Time frame: Day 15
Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with local and systemic AEs
Time frame: Day 7
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with unsolicited AEs
Time frame: Day 29
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
Time frame: Up to 1 year post-vaccination
Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)
GMT ratio
Time frame: Day 15
GMTs
Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5
Time frame: Day 1, 15, 180
GMFRs
Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5
Time frame: Day 1, 15, 180
SCRs
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Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5
Time frame: Day 1, 15, 180
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5
Proportion of participants with antibody titer ≥ LLoQ
Time frame: Day 1, 15, 180
GMTs
Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains
Time frame: Day 1, 15
GMFRs
Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains
Time frame: Day 1, 15
SCRs
Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains
Time frame: Day 1, 15
Proportion of subjects with antibody titer >=LLOQ
Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains
Time frame: Day 1, 15