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):
IgG antiPRP GMT, Short-term (=0,15 mcg/mL) and long-term (=1 mcg/mL) seroprotection percentages, seroconversion rate (increase in =2 folds in baseline IgG antiPRP antibody titer measured at day 30 after administration of the last vaccine dose).
Key secondary outcomes:
Percentage of local and systemic adverse events Evaluation times: 1h, 24h, 48h, 72h, Days 7 and 30 post-vaccination in each dose. -Occurrence of the Adverse Event (AE) -Description of the AE (name of the AE) -Duration of the AE (difference between start date and stop date) -Intensity of the AE (Mild, Moderate, Severe) -Seriousness of the AE (Serious, no serious) -Action taken with study drug (None, Dose reduced, Dose temporarily reduced, Discontinued ) -Outcomes (Recovered, improved, persisting or recovered with sequels) -Causality (1.Very likely, 2.Probable, 3.Possible, 4. Not Probable, 5. Non-related, 6. Not evaluable)