The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21
This is an extension study of the main study CT-COV-21, "A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901." This extension study is a prospective, open-label, multicenter study. In this extension study, approximately 500 participants who received the placebo and have remained blinded in the main study until Day 119 (90 days after the second vaccination of the main study) are enrolled and receive MVC-COV1901. Each participant will receive 2 doses of MVC-COV1901, administered 28 days apart via IM injection in the deltoid region, preferably of the non-dominant arm, at Day 1 and Day 29.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
274
Approximately 500 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (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
Number of Adverse Event (Safety of MVC-COV1901)
To evaluate the safety and tolerability of MVC-COV1901 from Day 1 to 28 days after the second dose of study intervention in terms of the number 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
Percentage of Adverse Event (Safety of MVC-COV1901)
To evaluate the safety and tolerability of MVC-COV1901 from Day 1 to 28 days after the second dose of study intervention in terms of the 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(Neutralizing Antibody)
To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention
Time frame: Day 1 to 28 days after second vaccination
Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
To evaluate the safety of MVC-COV1901 over the study period in terms of the number 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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, Taiwan
...and 1 more locations
Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
To evaluate the safety of MVC-COV1901 over the study period in terms of the 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
Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)
To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention
Time frame: Day 1 to 28 days after second vaccination