Flavivirus serostatus (i.e. dengue and JE) at baseline and safety data at each time point were summarized by vaccine group. The safety analysis set was defined for each dose as those children who received a vaccine; data were analyzed according to the vaccine received. Between

14 August 2010 and 31 July 2012, 550 participants were enrolled and 468 completed the Selleck 3MA study (Fig. 2). The main reason for discontinuation was voluntary withdrawal. No child withdrew owing to an AE. Mean age at inclusion, BMI, and ratio of male:female were similar in the three groups (Table 1). All children except one were Asian. Before vaccination, 2 children (2.0%) in JE-CV Group, 18 children (9.1%) in MMR Group and 5 children (2.3%) in Co-Ad Group were flavivirus seropositive i.e. they presented with pre-existing antibodies against either JE or dengue virus. All groups had low seroprotection/seropositivity rates before vaccination for all antigens (JE, measles, mumps and rubella). Non-inferiority was demonstrated for all analyses as the lower bound of the 95% CI of the difference in seroconversion rates between groups stood above −10.0% (Fig. 3). On Day 42 after vaccination, seroconversion rates were above 96% for all antigens in both concomitant selleck products and sequential groups (Fig. 3). The seropositivity/seroprotection

rates were similar to the seroconversion rates. The PP population only included children with GMTs of JE antibodies under the seroprotective threshold

of 10.0 1/dil before JE-CV vaccination. The GMTs of JE antibody were increased in all groups 42 days after JE-CV vaccination and were higher in the sequential administration groups compared with Co-Ad Group. For JE-CV, GMTs were 510 1/dil (95% CI: 356; 731) for JE-CV Group, 581 1/dil (95% CI: 449; 752) for MMR Group, and 332 1/dil (95% CI: 258; 426) for Co-Ad Group. Likewise, the GMTRs tended to be higher in JE-CV Group (102 [95% CI: Adenosine 71.3; 146]) and MMR Group (116 [95% CI: 89.8; 150]) compared with Co-Ad Group (66.3 [95% CI: 51.6; 85.2]); however, this difference is not clinically significant as the GMT values in all groups were well above the threshold considered to be protective. Results in the FAS were similar to those in the PP population. Persistence in seroprotection/seropositivity remained high for all four antigens up to 6 months after the last vaccination, as the level of antibody titers remained far above the threshold for seroprotection or seropositivity. The seroprotection rates for JE remained high at 12 months after first vaccination in the two groups with successive administration of the vaccines, and decreased slightly in the co-administration group (Fig. 4). All GMTs remained well above the level of protection (Fig. 4). Seroprotection rates remained high at 12 months after vaccination in all groups for measles, mumps, and rubella (Fig. 4).