No grade 3 fever was reported in any group. No trend for higher incidence rates of solicited general symptoms after dose 2 compared to dose 1 was observed (Fig. 3D–I). The combination of pneumococcal proteins with PS-conjugates BMS-754807 concentration seemed to be associated with higher incidences of solicited local and general symptoms than the control vaccine (23PPV at dose 1, placebo at dose 2) (Fig. 3). The formulations containing the pneumococcal proteins alone tended to be the least reactogenic. At least one unsolicited AE was reported after 44.7%–66.7% of primary investigational doses,

and 46.8% of control doses. At least one grade 3 unsolicited AE was reported following 4.5%–13.3% of primary investigational doses, and 8.5% of control doses (Table S1). At least one unsolicited AE considered causally related to vaccination was reported following 10.4%–33.3% of investigational vaccine doses and 12.8% of control doses (Table S2). No SAEs were reported in the investigational DAPT datasheet groups. One participant in the control group reported two SAEs (myalgia and skeletal injury), which were considered not to be causally related to vaccination. Pain was the most commonly reported solicited

local symptom in both groups post-booster (Fig. 3). Redness and swelling tended to be reported more frequently following vaccination with the higher protein-content formulation than the lower protein-content formulation. Grade 3 solicited local symptoms were reported by one participant in each group (Fig. 3). Headache and fatigue tended to be reported more frequently in the dPly/PhtD-30 group than in the dPly/PhtD-10 group, although one participant in the dPly/PhtD-10 group reported grade 3 fatigue that was considered to be vaccine-related. No other grade 3 solicited general symptoms were reported. Fever was reported by one participant (in the dPly/PhtD-10 group) (Fig. 3). Unsolicited Isotretinoin symptoms post-booster were reported by six participants (27.3%) in the dPly/PhtD-10 group and five participants (23.8%) in the dPly/PhtD-30 group. One participant in each group reported a grade 3

unsolicited AE (pharyngitis [dPly/PhtD-10] and upper respiratory tract infection [dPly/PhtD-30]). One participant in each group reported an unsolicited AE that was considered vaccine-related (aphthous stomatitis [dPly/PhtD-10] and peripheral edema in the right hand of a participant vaccinated in the left arm [dPly/PhtD-30]). No SAEs were reported during the booster study. No clinically significant changes in the hematology, biochemistry or urinary parameters were observed during the primary and booster study (data not shown). Before vaccination, all participants had anti-Ply and anti-PhtD concentrations above the assays cut-offs. All remained seropositive post-dose 1 and post-dose 2. Anti-Ply antibody GMCs increased after each vaccination in all groups except control. For PhtD, antibody GMCs increased following each vaccination in the groups that received a PhtD-containing formulation.