QDENGA® (TAK-003) is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes.

In Brazil, QDENGA is indicated for the prevention of dengue disease caused by any dengue virus serotype in individuals from 4 to 60 years of age and should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule pursuant to approved dosing regimen. 

The approval of QDENGA is based on results across 19 Phase 1, 2 and 3 trials with more than 28,000 children and adults, including four and a half years of follow-up data from the global, pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. The TIDES trial met its primary endpoint of overall vaccine efficacy (VE) by preventing 80.2% of symptomatic dengue cases 12 months after vaccination.¹ In addition, TAK-003 met its key secondary endpoint by preventing 90.4% of hospitalizations 18 months after vaccination.⁵ Efficacy varied by serotype (DENV-1 – 4).² ³ The TIDES exploratory analyses showed that throughout the four and a half-year study follow-up, TAK-003 prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases in the overall study population, which included both seropositive and seronegative individuals.³ TAK-003 has been generally well tolerated, with no evidence of increased incidence of severe disease in baseline sero-negative vaccine recipients, and no important safety risks identified, to date.⁴