The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine in two different dose forms in participants who are generally healthy or with stable pre-existing health conditions.
This is a Phase II, prospective, randomized, double-blinded (investigator/site staff and participants; Sponsor open), dose-comparison, multi-center study. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by comorbidity. All eligible participants will be randomized to receive 2 doses of either High-dose or Mid-dose of MVC-COV190 in a predefined ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
420
Approximately 300 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
Approximately 100 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
Hualien Tzu Chi Hospital
Hualien City, Taiwan
Shuang H Hospital
New Taipei City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Medical Hospital Linkou
Taoyuan, Taiwan
Incidence of Adverse Events(AEs) [Safety and Tolerability]
To evaluate the incidence of Adverse Events(AEs) of MVC-COV1901 from Visit 2 (Day 1) to Visit 6 (28 days after the second dose of study intervention) in terms of the number and percentage of participants with the occurrence of: Solicited local AEs (up to 7 days after each dose of study intervention) Solicited systemic AEs (up to 7 days after each dose of study intervention) Unsolicited AEs (up to 28 days after each dose of study intervention) AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs)
Time frame: Day 1 to 28 days after the second vaccination
Immunogenicity of MVC-COV1901
To evaluate the immunogenicity of High-dose MVC-COV1901, as compared to Mid-dose MVC-COV1901, in terms of neutralizing antibody titers.
Time frame: Day 1 to 28 days after the second vaccination
Incidence of Adverse Events(AEs) [Safety and Tolerability]
To evaluate the Incidence of Adverse Events(AEs) of MVC-COV1901 over the study period in terms of the number and percentage of participants with the occurrence of: \>= Grade 3 AE AE of Special Interest (AESI) Vaccine-Associated Enhanced Disease(VAED) Serious adverse events (SAEs)
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901
The antigen-specific immunoglobulin titers and neutralizing antibody titers at Visit 4 (28 days after the first dose of study intervention), Visit 6 (28 days after the second dose of study intervention), Visit 7 (90 days after the second dose of study intervention) and Visit 8 (180 days after the second dose of study intervention) in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers
Time frame: Day 1 to 180 days after the second vaccination
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