| Author | Biswal, Shibadas | |
| Author | Tabora, Charissa Borja | |
| Author | Vargas, Luis Martinez | |
| Author | Velásquez, Hector | |
| Author | Alera, Maria Theresa | |
| Author | Sierra, Victor | |
| Author | Arenales, Edith Johana Rodriguez | |
| Author | Yu, Delia | |
| Author | Wickramasinghe, V Pujitha | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Fernando, Asvini D. | |
| Author | Gunasekera, Dulanie | |
| Author | Kosalaraksa, Pope | |
| Author | Espinoza, Felix | |
| Author | Medina, Eduardo López | |
| Author | Bravo, Lulu | |
| Author | Tuboi, Suely | |
| Author | Hutagalung, Yanee | |
| Author | Garbes, Pedro | |
| Author | Escudero, Ian | |
| Author | Rauscher, Martina | |
| Author | Bizjajeva, Svetlana | |
| Author | LeFevre, Inge | |
| Author | Borkowski, Astrid | |
| Author | Llorens, Xavier Saez | |
| Author | Wallace, Derek | |
| Author | TIDES study group, TIDES study group | |
| Access date | 2020-06-01T14:32:42Z | |
| Available date | 2020-06-01T14:32:42Z | |
| Document date | 2020 | |
| Citation | BISWAL, 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. | pt_BR |
| ISSN | 0140-6736 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/41467 | |
| Description | Moreira 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 | pt_BR |
| Sponsorship | Takeda Vaccines | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | restricted access | pt_BR |
| Subject in Portuguese | Dengue | pt_BR |
| Subject in Portuguese | Virus da dengue | pt_BR |
| Subject in Portuguese | Vacina contra a Dengue | pt_BR |
| Subject in Portuguese | Placebo | pt_BR |
| Subject in Portuguese | Criança | pt_BR |
| Title | Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial | pt_BR |
| Type | Article | |
| DOI | 10.1016/S0140-6736(20)30414-1 | pt_BR |
| Abstract | 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 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. | pt_BR |
| Affilliation | Múltipla - ver em Notas. | pt_BR |
| Subject | Dengue | pt_BR |
| Subject | Dengue virus | pt_BR |
| Subject | Dengue Vaccines | pt_BR |
| Subject | Placebus | pt_BR |
| Subject | Children | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
