Created at Source Raw Value Validated value
Feb. 11, 2022, 8 a.m. oms

[Immunogenicity]Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 28 days after the second and third doses of the investigational product[Safety]-The incidence and causal relationship to the investigational product of all adverse events; adverse events resulting in death; serious adverse events other than death; important adverse events; and severe (Grade 3 or higher) adverse events occurring after the first dose of the investigational product to the post vaccination test-The incidence and causal relationship to the investigational product of adverse events resulting in death; serious adverse events other than death; and severe (Grade 3 or higher) adverse events occurring after the post vaccination test to the completion of follow-up-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited local adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited systemic adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of unsolicited adverse events-The highest body temperature between each administration of the investigational product and 6 days post-injection

[Immunogenicity]Geometric mean of neutralizing antibody titers against SARS-CoV-2 at 28 days after the second and third doses of the investigational product[Safety]-The incidence and causal relationship to the investigational product of all adverse events; adverse events resulting in death; serious adverse events other than death; important adverse events; and severe (Grade 3 or higher) adverse events occurring after the first dose of the investigational product to the post vaccination test-The incidence and causal relationship to the investigational product of adverse events resulting in death; serious adverse events other than death; and severe (Grade 3 or higher) adverse events occurring after the post vaccination test to the completion of follow-up-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited local adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of solicited systemic adverse events-The incidence; severity; number of days to onset; duration; incidence by the first/second/third dose; and causal relationship to the investigational product of unsolicited adverse events-The highest body temperature between each administration of the investigational product and 6 days post-injection