Safety:
Serious Adverse Events (SAEs) related to the vaccine (anaphylactic reaction, temperature higher than 40oC, hypotension, bronchospasm, glottis edema, convulsions). Measuring time: 1, 2, 3, 4, 5, 6, 7, 15 28 days after vaccination.
Reactogenicity:
Local Adverse Events (Pain in the injection site, redness in the injection site, induration in the injection site). Measuring time: Day 1,2,3,4,5,6,7, 15 and 28 after vaccination
General Adverse Events (Fever, Malaise, Headache and somnolence). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.
Description of the unexpected adverse events (Adverse Event name). Measuring time: 7, 15 and 28 days after the vaccination.
Intensity of adverse events (Mild, moderate, or severe). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.
Adverse events with causality relationship (related, unrelated). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.