Express Pharma|November 16-30, 2019
Takeda Pharmaceutical Company announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine. Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years. Vaccine efficacy (VE) was 80.2 per cent (95 per cent confidence interval [CI]: 73.3 per cent to 85.3 per cent; p<0.001) in the 12-month period after the second dose, which was administered three months after the first dose. Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue based on planned exploratory analyses of secondary endpoints (VE: 82.2 per cent [95 per cent CI: 74.5 per cent to 87.6 per cent] vs. VE: 74.9 per cent [95 per cent CI: 57.0 per cent to 85.4 per cent], respectively). Other exploratory analyses showed a 95.4 per cent reduction in dengue-associated hospitalisations (95 per cent CI: 88.4 per cent to 98.2 per cent). Efficacy against severe disease could not be assessed due to the limited number of cases. Onset of protection was seen after the first dose, with 81 per cent VE (95 per cent CI: 64.1 per cent to 90.0 per cent) between the first and second doses.
Takeda’s dengue vaccine candidate was generally well tolerated, and no important safety risks have been observed to date. The observed safety profile was consistent with results reported in previous studies of TAK-003.1,2,3,4 The TIDES trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.
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November 16-30, 2019