The two groups were comparable with respect to gender and age (Table 2). Of the 301 infants, 297 subjects received at least 1 vaccine/placebo dose, and participated in the intensive safety surveillance. Over the course of 42 days, 14 (9.5%) participants receiving rotavirus vaccine experienced a SAE compared with 23 (15.3%) among

those receiving the placebo, (p = 0.13) ( Table 3). The Selleck Venetoclax most common serious adverse events for participants receiving rotavirus vaccine were pneumonia (7.5%) and gastroenteritis (6.8%). The most common serious adverse events for participants in the placebo group were gastroenteritis (11.3%), malaria (5.3%), and pneumonia (5.3%). Four deaths on or before day 42 after any vaccination [1 (0.7%) in the vaccine group due to HIV/pneumonia and 3 (2.0%) in the placebo group due to therapeutic toxicity, febrile infection and unknown cause] were reported. None of these deaths were considered by the investigators to be vaccine-related. Clinicians (blinded as to vaccine or placebo status) indicated that they thought SAEs in 3 (2%) vaccine recipients and in 9 (6%) placebo recipients in the intensive safety surveillance cohort were related to receiving the study MS-275 supplier vaccine. These 12 SAEs were due to gastroenteritis. There were no statistical differences for overall or cause-specific SAEs by treatment group. Serious and non-serious adverse events were experienced among

137/147 (93.2%) vaccine recipients and 147/150 (98.0%) placebo recipients respectively (RR = 0.95, 95% CI 0.91–1.00; p = 0.05) ( Table 4). The most common clinical adverse events for participants in the vaccine group were pyrexia (65.3%), cough (59.9%), and diarrhea (48.3%). Likewise, the most common clinical adverse events for the placebo group were pyrexia (64.7%), cough (59.3%), and diarrhea (42.7%). There were no statistically significant differences between the two groups with

respect to vomiting, diarrhea and elevated temperature. Among enrolled participants, 1167 (89.8%) consented to HIV testing and 1158 (88.5%) were tested. Of the 1158, 21/581 (3.6%) children in the vaccine group and 17/577 (2.9%) in the placebo group were found to be HIV-infected at enrolment. Among these, the median CD4% others at enrollment for the vaccine recipients (n = 14 with CD4%) was 26% (range: 13–54%) and for placebo recipients (n = 12 with CD4%) was 21% (range: 9–35%) (p = 0.17). 37/38 (97.4%) HIV-infected participants completed SAE surveillance or were in the intensive safety cohort (21/649 vaccine recipients and 16/643 placebo recipients). Five of 21 (23.8%) vaccine recipients and 2/16 (12.5%) placebo recipients with safety follow up experienced an SAE within 14 days of any dose (p = 0.67) ( Table 5A); the most common SAE for both HIV-infected treatment groups was reported as HIV infection (19% in the vaccine group and 6.3% in the placebo group (p = 0.36) ( Table 5B). One of 21 (4.8%) vaccine recipients and 1/16 (6.