 Takeda's liver-tenuated dengue tetravalent vaccine candidate, TAK-003, has been shown to be immunogenic with acceptable reactogenicity in phase 1 trials and a randomized, double-blind, phase 2 study. The primary objective was to show immunologic equivalents in terms of geometric mean titers, GMT, of neutralizing antibodies to the four dengue serotypes one month after one dose of the lyophilized and liquid formulations. However, the primary endpoint was not met because immunologic equivalents after one dose was only shown for the DNV-2 serotype. Nonetheless, GMTs and seropositivity rates to all four serotypes were achieved with all formulations after two doses and are in line with what was observed in previous studies. The data support continuing further clinical development of the lyophilized TAK-003 formulation.