By pooling the groups, the target sample size of 60 toddlers per group (120 per pooled group) allowed for detection of a 10% increase in absolute values of the prevalence of grade 3 fever with at least 90% power. The primary objective

was reached if the asymptotic standardized 95% confidence interval (CI) of the defined difference included 0, or if the upper limit of this 95% CI was below 10%. All other analyses were descriptive. Incidences of local and general solicited symptoms and unsolicited AEs were calculated with exact 95% CIs after each vaccine dose and for overall primary doses, according to the type of symptom, intensity and relationship to vaccination. Descriptive immunogenicity analyses were performed www.selleckchem.com/products/MK-2206.html on the according-to-protocol (ATP) cohort for immunogenicity, comprising vaccinated toddlers who met all eligibility criteria, complied with the protocol-defined procedures and intervals, and with results for at least one antibody assay available. ELISA geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) with 95% CIs and seropositivity rates with exact 95% CIs were determined for each vaccine serotype or antigen. Selleck Quizartinib Analyses were performed with Statistical Analysis System (SAS® Institute

Inc., Cary, NC). Of the 257 vaccinated toddlers, 256 completed the study and 220 were included in the ATP cohort for immunogenicity (Fig. 1). One toddler in the PHiD-CV group was withdrawn due to a non-serious AE (eczema), not considered to be causally related to vaccination by the investigators. Demographic characteristics were similar between groups. The mean age in these the TVC was 16.8 ± 3.9 months at dose 1 (range: 12–24 months) and 23.2 ± 4.0 months at booster vaccination (range: 17–30 months). Most toddlers (98.8%) were

of white-Caucasian/European heritage and 50.6% were male. Post-dose 1, grade 3 fever was reported for one toddler in the pooled dPly/PhtD group and one toddler in the pooled PHiD-CV/dPly/PhtD group; no grade 3 fever was reported for toddlers in the PHiD-CV group (difference in rates, for each comparison: 0.97% [−6.10 to 5.32]). No grade 3 fever was reported post-dose 2 or post-booster. No statistically significant differences were detected in the incidence of grade 3 fever during primary vaccination with investigational formulations (protein alone or combined with PS-conjugates) compared to PHiD-CV; thus the primary objective was reached. Incidences of solicited local and general symptoms after vaccination with the investigational formulations were generally within the same ranges as for PHiD-CV, except swelling which was reported less frequently post-dose 1 in the dPly/PhtD-30 group (Fig. 2 and Fig. 3). Pain and redness were the most common solicited local symptoms after both primary doses (Fig. 2).