Serious Adverse Events - Phase 2 and 3 Relatedness to Study Product / Preferred Term / Severity Placebo (N=205) 15 mcg vaccine (N=625) # of Even ts # of Subj ects% of Subj ects 95% CI # of Events # of Subj ects% of Subj ects 95% CI Total 4 4 2, 0 0, 53 - 4, 92 8 8 1, 4 0, 66 - 2, 72 Unrelated 4 4 2, 0 0, 53 - 4, 92 8 8 1, 5 0, 66 - 2, 72 Abdominal adhesion Grade 2 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Abdominal symptom 1 1 0, 5 0, 01 - 2, 69 0 0 0, 0 0, 00 - 0, 59 Appendicitis Grade 2 1 1 0, 5 0, 01 - 2, 69 1 1 0, 2 0, 00 - 0, 89 Appendicitis Grade 3 1 1 0, 5 0, 01 - 2, 69 0 0 0, 0 0, 00 - 0, 59 Concussion Grade 2 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Diverticulitis Grade 2 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Pharyngitis Grade 2 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Sebaceous gland infection Grade 2 1 1 0, 5 0, 01 - 2, 69 0 0 0, 0 0, 00 - 0, 59 Tonsillitis Grade 3 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Viral infection Grade 3 0 0 0, 0 0, 00 - 1, 78 1 1 0, 2 0, 00 - 0, 89 Wound độ Grade 2 1 1 0, 5 0, 01 - 2, 69 1 1 0, 2 0, 00 - 0, 89 An SAE was reported for 1.4% of subjects in the 15 mcg vaccine group and 2.0% of subjects in the placebo group.