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Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH)

Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH)
November 26
14:09 2019

(UTV|COLOMBO) – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that updated results from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting. 

The data presented include an update on overall vaccine efficacy (VE) and a formal assessment of secondary efficacy endpoints by serotype, baseline serostatus and disease severity (18 months after the second dose, which was administered three months after the first dose). The TIDES trial met all secondary endpoints for which there were a sufficient number of cases. Overall vaccine efficacy and safety results from the second part of the study were generally consistent with the data reported in the primary endpoint analysis (overall VE was 73.3% [95% confidence interval (CI): 66.5% to 78.8%; p<0.001] in the 18-month analysis, and VE was 80.2% (95% CI: 73.3% to 85.3%) in the primary endpoint analysis [12 months after the second dose]). The primary endpoint analysis of overall VE was recently published in the New England Journal of Medicine, demonstrating protection against virologically-confirmed dengue (VCD) in children ages four to 16 years, regardless of previous exposure to dengue. 

 

 

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