Unsolicited Adverse Events during 21 Days Post Each Injection - Phase 2 and 3 Unsolicited AE Placebo 15 mcg vaccine Giá trị p n (%) (95% CI) n (%) (95% CI) st injection, n 205 625 Total number of unsolicited AEs 44 112 Subjects with at least one AE 37 (18, 0) 13, 04 - 24, 01 93 (14, 9) 12, 18 - 7, 92 0, 279 Subjects with at least one severe AE 3 (1, 5) 0, 30 - 4, 22 0 (0, 0) 0, 00 - 0, 59 0, 015 Subjects with at least one serious AE 0 (0, 0) 0, 00 - 1, 78 0 (0, 0) 0, 00 - 0, 59 N / A Subjects with at least one treatment-related AE 1 (0, 5) 0, 01 - 2, 69 0 (0, 0) 0, 00 - 0, 59 0, 247 Subjects with a fatal AE 0 (0, 0) 0, 00 - 1, 78 0 (0, 0) 0, 00 - 0, 59 N / A nd injection, n 201 615 Total number of unsolicited AEs 23 73 Subjects with at least one AE 22 (10, 9) 6, 99 - 16, 10 66 (10, 7) 8, 40 - 13, 45 0, 932 Subjects with at least one severe AE 2 (1, 0) 0, 12 - 3, 55 2 (0, 3) 0, 04 - 1, 17 0, 255 Subjects with at least one serious AE 4 (2, 0) 0, 54 - 5, 02 9 (1, 5) 0, 67 - 2, 76 0, 403 Subjects with at least one treatment-related AE 0 (0, 0) 0, 00 - 1, 82 0 (0, 0) 0, 00 - 0, 60 N / A Subjects with a fatal AE 0 (0, 0) (0, 00 - 1, 82) 0 (0, 0) (0, 00 - 0, 60) N / A Within 21 days following the first study product injection, unsolicited AEs were reported for 14.9% of subjects in the 15 mcg vaccine group compared with 18.0% of subjects in the placebo group.