The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
84
Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine
Normal saline solution
Clinical Trial Institution for Anning First Hospital
Kunming, Yunan, China
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody
Time frame: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody
Time frame: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies
Time frame: 28 days after each dose
Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.
Time frame: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..
Time frame: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.
Time frame: 28 days after each dose
Incidence of adverse events (AEs) after vaccination
Percentage of participants with AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.
Time frame: 28 days after the first or second vaccination
Incidence of solicited adverse events (AEs) after vaccination
Percentage of participants with solicited AEs for 30 minutes and 7 days following each vaccination (Days 0, 28) by intensity, relevance
Time frame: 30 minutes and 7 days after the first or second vaccination
Incidence of unsolicited adverse events (AEs) after vaccination
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Percentage of participants with unsolicited AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.
Time frame: 28 days after the first or second vaccination
Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters
Safety Laboratory Values (Serum Chemistry, Hematology)
Time frame: Day 4 after first or second vaccination
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Percentage of participants with SAEs or AESIs for 12month after last dose vaccination
Time frame: up to 12month after last dose vaccination