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):
Serious Adverse Events related to the vaccine (Adverse Events “serious” with causality relationship “very probable” or “probable”). Measuring time: Every 3 months until 20 months
Overall Survival (Time from the date of each patient randomization until the date of death, regardless of the cause of death). Measuring time: 20 months.
Key secondary outcomes:
Progression-free survival (time from randomization until objective tumor progression or death). Measuring time: 20 months.
Antitumor response (RECIST-version 1.1 scale). Measuring time: every 4 months up to 20 months.
Immune response:
IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, 85, 169, 337 days.
Recognition and lytic capacity of IgM and IgG antibodies induced by vaccination and directed to NGcGM3 on tumor lines expressing ganglioside (flow cytometry). Measuring time: At baseline, 85, 169, 337 days.
Safety:
Adverse Events-AE (Description of the AE (Name of the AE) Intensity of the AE (mild, moderate, severe, life threatening, death), Causality relationship (very probable, probable, possible, unlikely, not related, not evaluable), Gravity (serious, non-serious), Previous knowledge (expected, non-expected), Result (recovered, improved, squeals, death), Treatment (none, medication, surgical procedure, transfusion, other). Measuring time: every 3 months up to 20 months.