This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006)in healthy participants aged 18 or more.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
450
SARS-CoV-2 mRNA Vaccine
SARS-CoV-2 mRNA Vaccine
Placebo
Hebei Provincial Center For Disease Control and Prevention
Shijiazhuang, Hebei, China
Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu, China
Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: 14 days after the second dose
Adverse events (AEs), including solicited AEs and unsolicited AEs
Time frame: From the first dose through 30 days following the second dose
AEs associated with the study intervention
Time frame: From the first dose through 30 days following the second dose
Serious adverse events (SAEs)
Time frame: from the first dose through 12 months after the second dose.
Adverse events of special interest (AESIs)
Time frame: rom the first dose through 12 months after the second dose.
Laboratory test related adverse events
Time frame: 4 days following each dose.
Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: from the first dose through 21 days
GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Time frame: 30, 90, 180 and 360 days after the second dose.
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