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):
Immunogenicity (ELISA technique for tetanus antitoxin. Tetanus antitoxin with values at the rate of 0.01 IU / mL (serum antitoxin units per milliliter) Protective titers, From 0.1 IU / mL, reliable protection titles are reached and Values above 1-UI/mL--- Reliable Titles which confer long-term protection. Measuring time: pre-and post-vaccination response at the day 21.
Key secondary outcomes:
Reactogenicity (Local adverse events (Pain in the injection site, redness in the injection site, induration in the injection site); general adverse events (Fever, Malaise, Headache); unexpected adverse events). Measuring time: 30 days. Active daily surveillance in both groups during 7 days from the day of immunization and after weekly until the remaining 30 days.