The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.
This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center, multi-regional study; the Sponsor will be blinded until the interim analysis. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by age (≥ 20 to \< 65 years and ≥ 65 years of age).All eligible participants will be randomized to receive 2 doses of either MVC-COV1901 or placebo in a predefined ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,854
Approximately 3180 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 530 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
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901)
To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1) to Visit 7 (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 second vaccination
Immunogenicity of MVC-COV1901
To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers
Time frame: Day 1 to 28 days after second vaccination
Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901)
To evaluate the safety 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 second vaccination
lot to lot consistency
To evaluate the lot-to-lot consistency of MVC-COV1901 in participants of the ≥ 20 to \< 65 years age group, the equivalence of the neutralizing antibody Geometric Mean Titer(GMT) among 3 different lots of MVC-COV1901
Time frame: Day 1 to 28 days after second vaccination
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National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang-Guang Memorial Hospital Lin-Kou
Taoyuan District, Taiwan
...and 2 more locations