Data from Pharmawand - Curated by EPG Health - Date added 09 November 2019

Takeda Pharmaceutical Company Limited announced that results from the primary endpoint analysis of the ongoing pivotal Phase III 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% (95% confidence interval [CI]: 73.3% to 85.3%; 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% [95% CI: 74.5% to 87.6%] vs. VE: 74.9% [95% CI: 57.0% to 85.4%], respectively). Other exploratory analyses showed a 95.4% reduction in dengue-associated hospitalizations (95% CI: 88.4% to 98.2%). 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% VE (95% CI: 64.1% to 90.0%) 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.The TIDES trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.

The Phase III TIDES trial is ongoing, and longer-term data will be important in determining the efficacy and safety profile, particularly in baseline seronegative participants with dengue serotype 3 virus. Takeda is engaging global health experts to provide insights into the burden of dengue in endemic regions and analyses of results from the trial. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world..

See- "Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents".- Shibadas Biswal, M.D., Humberto Reynales, M.D., Ph.D., Xavier Saez-Llorens, M.D.et al., for the TIDES Study Group*-November 6, 2019 DOI: 10.1056/NEJMoa1903869.

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