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

dc.creatorBiswal, Shibadas
dc.creatorTabora, Charissa Borja
dc.creatorVargas, Luis Martinez
dc.creatorVelásquez, Hector
dc.creatorAlera, Maria Theresa
dc.creatorSierra, Victor
dc.creatorArenales, Edith Johana Rodriguez
dc.creatorYu, Delia
dc.creatorWickramasinghe, V Pujitha
dc.creatorMoreira Junior, Edson Duarte
dc.creatorFernando, Asvini D.
dc.creatorGunasekera, Dulanie
dc.creatorKosalaraksa, Pope
dc.creatorEspinoza, Felix
dc.creatorMedina, Eduardo López
dc.creatorBravo, Lulu
dc.creatorTuboi, Suely
dc.creatorHutagalung, Yanee
dc.creatorGarbes, Pedro
dc.creatorEscudero, Ian
dc.creatorRauscher, Martina
dc.creatorBizjajeva, Svetlana
dc.creatorLeFevre, Inge
dc.creatorBorkowski, Astrid
dc.creatorLlorens, Xavier Saez
dc.creatorWallace, Derek
dc.creatorTIDES study group, TIDES study group
dc.date2020-06-01T14:32:42Z
dc.date2020-06-01T14:32:42Z
dc.date2020
dc.date.accessioned2023-09-26T22:15:23Z
dc.date.available2023-09-26T22:15:23Z
dc.identifierBISWAL, Shibadas et al. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial. Lancet, p. 1-11, Mar. 2020.
dc.identifier0140-6736
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/41467
dc.identifier10.1016/S0140-6736(20)30414-1
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8876917
dc.descriptionMoreira Júnior, Edson Duarte - Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Salvador, BA, Brasil. "Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta à informação no documento". (Prof A D Fernando MD); Faculty of Medical Sciences, University of Sri Jayawardenenpura, Gangodawila, Sri Lanka (Prof D Gunasekera MD); Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand (P Kosalaraksa MD); National Autonomous University of Nicaragua, León, Nicaragua (F Espinoza MD); Centro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Colombia , (E López -Medina MD); University of the Philippines Manila, Ermita, Philippines (Prof L Bravo MD); Takeda Pharmaceuticals, São Paulo, Brazil (S Tuboi MD); Takeda Vaccines, Singapore (Y Hutagalung MD, I Escudero MD); Takeda Pharmaceuticals International, Zurich, Switzerland (M Rauscher PhD, S Bizjajeva PhD, I LeFevre MD, A Borkowski MD); and Hospital del Niño Dr José Renán Esquivel, Sistema Nacional de Investigación at Secretaría Nacional de Ciencia y Tecnología, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama (Prof Xavier Saez-Llorens MD
dc.descriptionTakeda Vaccines
dc.descriptionBackground 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 Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4–16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927.
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier
dc.rightsrestricted access
dc.subjectDengue
dc.subjectVirus da dengue
dc.subjectVacina contra a Dengue
dc.subjectPlacebo
dc.subjectCriança
dc.subjectDengue
dc.subjectDengue virus
dc.subjectDengue Vaccines
dc.subjectPlacebus
dc.subjectChildren
dc.titleEfficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial
dc.typeArticle


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