Fig 1.
TAK-003, tetravalent dengue vaccine candidate; YF-17D, live attenuated yellow fever vaccine.
Fig 2.
aThis includes 1 participant who received YF-17D vaccine instead of Placebo at 3rd vaccination. AE, adverse event; LTF, lost to follow-up; PD, protocol deviation; TAK-003, tetravalent dengue vaccine candidate; WOC, withdrawal of consent; YF-17D, live attenuated yellow fever vaccine.
Table 1.
Demographic and baseline characteristics (safety set).
Table 2.
Non-inferiority comparisons (YF PPS and PPS).
Table 3.
Geometric mean titers of anti-YF neutralizing antibodies and seroprotection rates (95% confidence interval) on Days 1 (Month 0), 30 (Month 1), 180 (Month 6), and 210 (Month 7) (YF PPS).
Fig 3.
Geometric mean titers (GMTs) of neutralizing antibodies against each DENV serotype in each of the vaccine groups (PPS).
Number of participants included at each time point are given in the table below the graphs. DENV, dengue virus; PPS, per-protocol set.
Fig 4.
Seropositivity rates (95% confidence intervals) against individual and multiple DENV serotypes in each vaccine group (PPS).
Number of participants included at each time point are given in the table below the graphs. DENV, dengue virus.
Table 4.
Number (%) of participants reporting solicited local adverse events (AEs) within 7 days or systemic AEs within 14 days after any vaccination overall and by severity (safety set).
Table 5.
Number (%) of participants reporting unsolicited adverse events (AEs) within 28 days post vaccination, and the number of events reported by MedDRA system organ class and preferred term.
Data are shown for preferred terms in ≥2% of participants in any vaccine group (safety set).