Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

@article{Biswal2020EfficacyOA,
  title={Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial},
  author={Shibadas Biswal and Charissa Fay Corazon Borja-Tabora and Luis Martinez Vargas and Hector Vel{\'a}squez and Maria Theresa P. Alera and Victor Y. Sierra and Edith Johana Rodriguez-Arenales and Delia Yu and Vithanage Pujitha Wickramasinghe and Edson Duarte Moreira and Asvini D. Fernando and Dulanie Gunasekera and Pope Kosalaraksa and F{\'e}lix Espinoza and Eduardo L{\'o}pez-Medina and Lulu C. Bravo and Suely Hiromi Tuboi and Yanee Hutagalung and Pedro Garbes and Ian Escudero and Martina Rauscher and Svetlana Bizjajeva and Inge Lefevre and Astrid Borkowski and Xavier S{\'a}ez-Llorens and Derek Wallace and Alys Concepci{\'o}n and Ana Cecilia Villarreal and Asvini D. Fernando and Chukiat Sirivichayakul and Edith Johana Rodriguez-Arenales and Humberto Reynales and Kleber Giovanni Luz and Jose ¤ Jimeno and Lakkumar Fernando and Luis Rivera and Onanong Manacharoen and P{\'i}o L{\'o}pez and Vithanage Pujitha Wickramasinghe and Reynaldo Dietze and Rivaldo Ven{\^a}ncio da Cunha and Veerachai Watanaveeradej and Manja Brose and Kelley J Moss and Seetha Meyer and Vianney Tricou},
  journal={The Lancet},
  year={2020},
  volume={395},
  pages={1423-1433}
}
BACKGROUND A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. METHODS We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and… Expand
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TLDR
Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study of TAK-003. Expand
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TLDR
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TLDR
TAK-003 was immunogenic against all four serotypes and was well tolerated in dengue-naïve adolescents living in Mexico City, an area considered non-endemic for d Dengue. Expand
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TLDR
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Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study of TAK-003. Expand
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