Document Classification

Section Type: RESULTS

Text: Although the overall incidence of vaccine-related serious adverse events (1 in each group) and the all-cause mortality rate (201/3958 vs 177/3967 ; 5. 7 [95 % CI, 4. 9-6. 5] vs 5. 0 [95 % CI, 4. 3-5. 7] deaths per 100 person-years ; P =. 20) were not statistically different between groups, the mortality rate in patients with staphylococcal infections was significantly higher among V710 vaccine than placebo recipients (15/73 vs 4/96 ; 23. 0 [95 % CI, 12. 9-37. 9] vs 4. 2 [95 % CI, 1. 2-10. 8] per 100 person-years ; difference, 18. 8 [95 % CI, 8. 0-34. 1] per 100 person-years).