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<p>The approved, live-attenuated tetravalent dengue vaccine TAK-003 has undergone extensive preclinical and clinical assessment. This review provides an overview of the rationale for some key decisions made during TAK-003 development. These include decisions around vaccine composition, assessment of factors that may be associated with the safety of live-attenuated viral vaccines, dosing schedule, immunogenicity assessments, and design of the pivotal phase 3 efficacy study.</p>

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The TAK-003 story: key decisions that shaped development of a tetravalent dengue vaccine

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月2日

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  • Ian Escudero,
  • Dieter Gniel,
  • Shibadas Biswal,
  • Eckhardt Petri,
  • Gonzalo Perez,
  • Mayuri Sharma,
  • John Weil,
  • Derek Wallace

摘要

The approved, live-attenuated tetravalent dengue vaccine TAK-003 has undergone extensive preclinical and clinical assessment. This review provides an overview of the rationale for some key decisions made during TAK-003 development. These include decisions around vaccine composition, assessment of factors that may be associated with the safety of live-attenuated viral vaccines, dosing schedule, immunogenicity assessments, and design of the pivotal phase 3 efficacy study.