Objectives
SECONDARY
The primary study objective was non-inferiority (NI) of the YF seroprotection rate one month after concomitant administration of YF-17D with TAK-003 (Group 3) vs YF-17D with placebo (Group 1).Secondary objectives included assessments of NI of GMTs of neutralizing antibodies against individual DENV serotypes one month after the second dose of TAK-003 (Month 4) concomitantly administered with YF-17D vs TAK-003 with placebo (Group 3 vs Group 2) and NI of GMTs of neutralizing antibodies against YF, one month following concomitant administration of YF-17D with TAK-003 compared to YF-17D with placebo (Month 1; Group 3 vs Group 1).Additional secondary immunogenicity objectives were seropositivity rates for individual DENV serotypes, one month post-second dose of TAK-003; GMTs of neutralizing antibodies and the seropositivity rates for all four DENV serotypes, one month post-first dose of TAK-003; GMTs of YF neutralizing antibodies and seroprotection rate in Group 2 one month post-YF-17D; GMTs of neutralizing antibodies and seropositivity rates for all four DENV serotypes one month post-second dose of TAK-003 in Group 1. Safety profiles of each vaccine were also assessed.