None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Administer a single dose of each IP into the deltoid muscle.
- Experimental (GC4006A): 0.15mL/0.3mL/0.5mL
- Placebo comparator (Normal Saline): 0.15mL/0.3mL/0.5mL
Sponsors
Koera University Guro Hospital
Hallym University Medical Center-Kangnam
Korea University Ansan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Males and females aged 19–64 who voluntarily agree to participate and provide written informed consent - =16 weeks since last COVID-19 vaccination - Subjects of childbearing potential who agree to use highly effective contraception during the study period - Female subjects of childbearing potential who test negative on a pregnancy test prior to administration of the investigational product. - Subjects who agree not to donate or receive blood (including whole blood, plasma, platelets, and platelet-rich plasma) during participation in the clinical trial.
Exclusion criteria
Exclusion criteria: - Positive SARS-CoV-2 test (RT-PCR) or Rapid Antigen Test at screening or randomization - Subjects who tested positive for COVID-19 within 16 weeks prior to the date of IP administration - Subjects who had an acute febrile illness with a temperature of 38°C or higher within 72 hours prior to IP administration, or those suspected of or having symptoms of other infectious diseases - History of serious adverse event, allergy, or hypersensitivity to the vaccines - Subjects with a history or suspicion of drug or alcohol abuse within 6 months prior to IP administration - Subjects who have received other investigational products or medical devices within 24 weeks prior to participating in this clinical trial - Pregnant or lactating women - Subjects who are deemed unsuitable for participation in this clinical trial by the investigator for any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited local and systemic adverse events;Acute adverse events;Unsolicited adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events (SAE), Adverse events of special interest (AESI), Medically Attended Adverse Events (MAAE);Vital signs, laboratory tests, and physical examinations;Electrocardiograms;Immunogenicity response (SRR, GMT, GMFR for neutralizing antibodies; SRR, GMC, GMFR for binding antibodies);Cell-mediated immunity | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Suk Lee
Koera University Guro Hospital
Outcome results
None listed