SOBERANA 02-FaseIII

INTERVENTION: Experimental Group 1: FINLAY‐FR‐2 25 ug RBD‐TT, Intramuscular (IM), 0.5 mL, 0 ‐ 28 days. Presentation: Vial with single dose. Experimental Group 2: FINLAY‐FR‐2 25 ug RBD‐TT, IM, 0.5 mL, 0 ‐ 28 days + FINLAY‐FR‐1A (50 ug d‐RBD+ alumina, IM, 0.5 mL) as booster dose 56 days. Presentation: Vial with single dose. Placebo Group: IM, 0.5 mL, 0 ‐ 28 days. Presentation: Vial with single dose. Immunogenicity, Vaccine CONDITION: COVID‐19 COVID‐19 ; COVID‐19 Disease Prevention PRIMARY OUTCOME: Virologically confirmed symptomatic infection of Covid‐19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. INCLUSION CRITERIA: 1. Subjects who give their informed consent to participate in the study in writing. 2. Subjects aged between 19 and 80 years. 3. Women of childbearing age who use contraceptive methods during the study and are willing to use them up to 3 months after the corresponding vaccination schedule has concluded. SECONDARY OUTCOME: 1. Confirmed Covid‐19 infection with signs of severe systemic disease. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 2. Confirmed SARS‐Cov‐2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 3. Death from causes directly attributable to a complication of COVID‐19 Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. 4. Virologically confirmed disease of Covid‐19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days. 5. Duration of the disease, measured from: Time to negativization and Duration of symptoms 6. Immunogenicity (IgG antibody concentration, Neutralizing antibody titre, determined by neutralization assay and ACE2‐RBD interaction inhibition assay (% inhibition at 1/100 dilution; ID50). Measurement time: from 14 days after the candidate's first dose and until the end of the study (approximately 160 days) 7. Reactogenicity (Incidence of Local and systemic Adverse Events (AE) (They will measure as: ‐Occurrence of the AE (Yes, No), Duration (Time from onset date until end date of event), Time of onset (Time from the previous dose to the onset of AE), ‐Intensity of the AE (mild, moderate, severe), ‐Severe (Serious, not serious), ‐Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), ‐ Causal relationship (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: 3 days after each dose 8. Safety Incidence of Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from onset date until end date of event), Time of onset (Time from the previous dose to the onset of AE), ‐Intensity of the AE (mild, moderate, severe), ‐Severe (Serious, not serious), ‐Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), ‐Causality relationship (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: 28 days after each dose