Shots:

• The submission is based on a P-III TIDES trial assessing TAK-003 (0.5ml- SC) vs PBO in 20-000+ healthy children & adolescents aged 4-16yrs. to prevent dengue fever of any severity and due to any of the four dengue virus serotypes
• The trial met its 1EPs showed overall vaccine efficacy against VCD @12 mos. follow-up and all 2EPs @18 mos. follow-up. The results demonstrated TAK-003 was well-tolerated with no observed safety issue
• The company plans to file for regulatory submission in the US and other countries during 2021. EMA to conduct first-ever parallel assessment for TAK-003 for use in the EU and through the EU-M4all procedure for countries outside of the EU

 ­ Ref: Takeda | Image: Takeda