The P-III (TIDES) trial evaluated the 2 doses of TAK-003 (0.5ml, SC) vs PBO in a ratio (2:1) in 20,000 healthy children & adolescents ages 4 to 16yrs. for the prevention of dengue fever of any severity & due to any of the four dengue virus serotypes for 4.5yrs.
The results showed a vaccine efficacy of 84.1% with 85.9% & 79.3% VE in seropositive & negative patients, overall VE of 61.2% against VCD with 64.2% & 53.5% VE in seropositive & negative patients. The results were consistent with prior reported results, were well tolerated with no imp. safety risks & no evidence of disease enhancement over 54mos. follow-up exploratory analysis
TAK-003 is currently under EMA’s review for dengue disease in children & adults and select dengue-endemic countries
Ref: Businesswire | Image: Takeda
