The purpose of this study is to evaluate the efficacy, safety and immunogenicity of GX-19N in healthy individuals who have received one of COVID-19 vaccine authorized for emergency use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
First occurrence of COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed COVID-19 as described in the study
Time frame: Up to 1 year after first vaccination
Incidence of severe solicited adverse events (AEs)
Percentage of subjects reporting grade 3 or higher AEs after each vaccination
Time frame: Up to 7 days after each vaccination
Incidence of AEs and Serious AEs (SAEs) after each vaccination
Percentage of subjects reporting AEs and SAEs after each vaccination
Time frame: Up to 1 month after each vaccination
Incidence of SAE, and Adverse events of special interest (AESIs), which relevant to COVID-19 including possible vaccine-enhanced disease
SAE and AESIs reported in all subjects at any time after the first vaccination
Time frame: Up to 1 year after first vaccination
First occurrence of severe COVID-19 at least 14 days after the second vaccination
Symptomatic, virologically confirmed severe COVID-19 as described in the study
Time frame: Up to 1 year after first vaccination
Cell-mediated immune responses after vaccination
Antigen-specific T cell response in a subset of Phase 2/3
Time frame: Up to 1 year after first vaccination
Antibody responses after vaccination
Analysis of binding antibodies and neutralizing antibodies in a subset of Phase 2/3
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Time frame: Up to 1 year after first vaccination