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) Safety - Adverse clinical events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Relation of causality (consistent with vaccination, indeterminate, inconsistent with vaccination, not classifiable), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Condition present and unchanged, Worsening, Death caused by this event)). Measurement time: before the application of each dose of the vaccine and in the first hour after the inoculation of the product (in each dose), and on the 7th day after the first dose.
2) A non-inferiority immunobridging study to extrapolate the efficacy of the Abdala vaccine in paediatric ages of 3-18 years, from immunogenicity results based on the evaluation of neutralizing antibodies (NAb) against SARS-CoV-2. The design followed basic principles for this type of analyses according WHO guidelines.
Key secondary outcomes:
1) Proportion of subjects with SARS-CoV-2 anti-RBD IgG antibodies seroconversion (seroconversion will be considered as that ≥ 4 times the initial determination of the antibody titer). Measurement time: at 42 (+3 days) with respect to baseline time.
2) Inhibition to ACE2 (by ELISA - Enzyme-linked immunosorbent assay). Measurement time: at 42 (+3 days) with respect to baseline time.
3) SARS-CoV-2 viral neutralization response percentage (only 10% of those samples that have ≥ 30% inhibition at a 1/100 dilution will be evaluated in the RBD-ACE-2 binding neutralization assay ). Measurement time: at 42 (+3 days) with respect to baseline time.