Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the candidate's last dose.
2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: from 14 days after the candidate's last dose.
3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: from 14 days after the candidate's last dose.
4. Death from causes directly attributable to a complication of COVID-19. Measurement time: from 14 days after the candidate's last dose.
5. Case Cumulative incidence: Measurement time: from 14 days after the candidate's last dose.
6. Evaluate the immunogenicity of a dose of the vaccine candidate, in convalescent patients from COVID-19 with mild and moderate clinical symptoms and asymptomatic PCR positive.
Key secondary outcomes:
1. Virologically confirmed disease of Covid-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days.
2. Confirmed Covid-19 infection with signs of severe systemic disease. Measurement time: starting 14 days after the candidate's first dose and up to 28 days.
3. Confirmed SARS-Cov-2 infection from routine surveillance or determinations of the presence of antigens. Measurement time: starting 14 days after the candidate's first dose and up to 28 days.
4. Death from causes directly attributable to a complication of COVID-19. Measurement time: starting 14 days after the candidate's first dose and up to 28 days.
5. 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.
6. Proportion of hospitalized subjects. Measurement time: from 14 days after the candidate's first dose.
8. Evaluate the duration of the immune response in primed subjects.
9. Evaluate the capacity to reinforce the immune response of SOBERANA 01 and SOBERANA Plus, after administration of the planned heterologous scheme, between 5-6 months after the last dose.
10. Evaluate the duration of the immune response induced by both booster doses for a minimum period of 6 months.