METHODS
dengue
DENGUE, EVENTS, DENGUE
The dengue episodes reported in this article were observed during a phase 3 randomized, double-blind, placebo-controlled trial of TAK-003 in eight countries in Latin America and Asia considered to be endemic for dengue (NCT02747927). During the trial, healthy children and adolescents age 4 to 16 years were randomized 2:1 to receive either two doses of TAK-003 (months 0 and 3) or placebo. Full details of enrollment criteria and trial procedures have been published previously.In brief, the multipart trial had up to 4.5 years of follow-up for individual participants after administration of the two doses of TAK-003 or placebo,Dengue RNA was detected and quantified with a validated serotype-specific RT-PCR assay. The upper limit of quantification (ULoQ) was determined to be 85,714,286 genome copy equivalents per milliliter (logDescriptive details of VCD in participants who experienced multiple episodes between the first dose and 4.5 years after the second dose are presented. Relative risk was calculated as the number of events divided by the number of participants in the TAK-003 group, over the number of events divided by the number of participants in the placebo group. All the analyses presented in this manuscript are exploratory and post hoc in nature.