The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants aged ≥ 12 to \< 18 years.
This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center study; the Sponsor will be blinded until the interim analysis. Participants aged ≥ 12 to \< 18 years will be enrolled. All eligible participants will be randomized to receive either MVC-COV1901 or placebo in a 6:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
399
Approximately 330 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 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region
Mackay Memorial Hospital Hsinchu
Hsinchu, Taiwan
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital-HsinChu
Taipei, 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-COV1901-1
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Geometric mean titers (GMT)
Time frame: Day 1 to 28 days after the second vaccination
Immunogenicity of MVC-COV1901-2
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -Seroconversion rate (SCR)
Time frame: Day 1 to 28 days after the second vaccination
Immunogenicity of MVC-COV1901-3
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers. The neutralizing antibody titers at Visit 6 (28 days after the second dose of study intervention) in terms of: -GMT ratio
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)
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National Taiwan University Hosptial
Taipei, Taiwan
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-1
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. 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 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-2
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. 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 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -SCR
Time frame: Day 1 to 180 days after the second vaccination
Immunogenicity of MVC-COV1901-3
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of antigen-specific immunoglobulin titers and neutralizing antibody titers. 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 8 (90 days after the second dose of study intervention) and Visit 9 (180 days after the second dose of study intervention) in terms of: -GMT ratio
Time frame: Day 1 to 180 days after the second vaccination