The objective of this study is to evaluate the immunogenicity and safety of SCTV01C in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01C compared with either Sinopharm inactivated COVID-19 vaccine or Comirnaty in participants aged ≥18 years and previously fully immunized with either inactivated or mRNA COVID-19 vaccine or previously diagnosed with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
intramuscular injection
intramuscular injection
intramuscular injection
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of solicited AEs from D0 to D7 after study vaccination.
Time frame: Day 0 to Day 7 after the study vaccination
Cohort 2: Incidence and severity of unsolicited AEs from D0 to D28 after study vaccination.
Time frame: Day 0 to Day 28 after the study vaccination
Cohort 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
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Cohort 1: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 28 after the study vaccination
Cohort 2: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Delta variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Seroresponse rates of neutralizing antibodies to Omicron variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Delta (B.1.617.2) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Cohort 1: GMT of neutralizing antibodies to Omicron (B.1.1.529) variant on D28 in different subgroup.
Time frame: Day 28 after the study vaccination
Cohort 2: Incidence and severity of SAEs and AESIs within 180 days after study vaccination.
Time frame: Day 0 to Day 180 after the study vaccination