Evidence map›Paper›PMID 33319249›Full record

Trial reportThe Journal of infectious diseases2022

Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination.

Eduardo López-Medina, Shibadas Biswal, Xavier Saez-Llorens, Charissa Borja-Tabora, Lulu Bravo, Chukiat Sirivichayakul, Luis Martinez Vargas, Maria Theresa Alera, Hector Velásquez, Humberto Reynales and 20 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02747927 (Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine), which is not on this map. Cited by 66 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02747927 phase3completednot on this map

Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old

TypeinterventionalSponsorTakedaRan2016 to 2024Enrolled20,099ConditionsHealthy VolunteersArmsPlacebo, Tetravalent Dengue Vaccine (TDV)
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  11. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Trial
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Eduardo López-MedinaCentro de Estudios en Infectología Pediátrica, Universidad del Valle and Centro Médico Imbanaco, Cali, Colombia.
Shibadas BiswalTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Xavier Saez-LlorensHospital del Niño Dr José Renán Esquivel, Sistema Nacional de Investigación, Secretaria Nacional de Ciencia y Tecnologia, Centro de Vacunación Internacional, Panama City, Panama.
Charissa Borja-TaboraResearch Institute for Tropical Medicine, Muntinlupa, Philippines.
Lulu BravoUniversity of the Philippines Manila, Ermita, Philippines.
Chukiat SirivichayakulDepartment of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Luis Martinez VargasCentro de Atención e Investigación Médica Dominicana, Santo Domingo, Dominican Republic.
Maria Theresa AleraPhilippines-Armed Forces Research Institute of Medical Sciences Virology Research Unit, Cebu City, Philippines.
Hector VelásquezCentro de Atención e Investigación Médica, Acacias, Colombia.
Humberto ReynalesCentro de Atención e Investigación Médica, Yopal, Colombia.
Luis RiveraHospital Maternidad Nuestra Senora de Altagracia, Santo Domingo, Dominican Republic.
Veerachai WatanaveeradejPhramongkutklao Hospital, Bangkok, Thailand.
Edith Johana Rodriguez-ArenalesCentro de Atención e Investigación Médica, Aguazul, Colombia.
Delia YuDe La Salle Medical and Health Sciences Institute, Dasmariñas, Philippines.
Felix EspinozaNational Autonomous University of Nicaragua, León, Nicaragua.
Reynaldo DietzeUniversidade Federal Do Espirito Santo, Hospital Universitário Cassiano Antônio de Moraes, Vitória, Brazil.
Lak Kumar FernandoCentre for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Negombo, Sri Lanka.
Pujitha WickramasingheUniversity of Colombo, Colombo, Sri Lanka.
Edson Duarte MoreiraAssociação Obras Sociais Irmã Dulce Hospital Santo Antônio and Oswaldo Cruz Foundation, Bahia, Brazil.
Asvini D FernandoFaculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka.
Dulanie GunasekeraFaculty of Medical Sciences, University of Sri Jayawardenenpura, Nugegoda, Sri Lanka.
Kleber LuzInstituto de Medicina Tropical da Universidade Federal do Rio Grande do Norte, Natal, Brazil.
Rivaldo Venâncio da CunhaUniversidade Federal de Mato Grosso do Sul, Campo Grande, Brazil.
Vianney TricouTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Martina RauscherTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Mengya LiuTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Inge LeFevreTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Derek WallaceTakeda Vaccines, Inc., Boston, Massachusetts, USA.
Pope KosalaraksaFaculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Astrid BorkowskiTakeda Pharmaceuticals International AG, Zurich, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTakeda's dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update.

methodsChildren (20 099, 4-16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR.

resultsCumulative efficacy against dengue approximately 27 months since first dose was 72.7% (95% confidence interval [CI], 67.1%-77.3%), including 67.0% (95% CI, 53.6%-76.5%) in dengue-naive and 89.2% (95% CI, 82.4%-93.3%) against hospitalized dengue. In the second year, decline in efficacy was observed (56.2%; 95% CI, 42.3%-66.8%) with the largest decline in 4-5 year olds (24.5%; 95% CI, -34.2% to 57.5%); efficacy was 60.6% (95% CI, 43.8%-72.4%) in 6-11 year and 71.2% (95% CI, 41.0%-85.9%) in 12-16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to efficacy differences in year-by-year analysis. No related serious adverse events occurred during the second year.

conclusionsTAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further.Clinical Trials Registration. NCT02747927.Takeda's tetravalent dengue vaccine (TAK-003) continued to demonstrate benefit in reducing dengue independent of baseline serostatus up to 2 years after completing vaccination with some decline in efficacy during the second year in 4-16 year olds in dengue-endemic countries.

Indexed as

DengueDengue VaccinesDengue VirusAdolescentAntibodies, NeutralizingAntibodies, ViralChildChild, PreschoolDouble-Blind MethodHumansVaccinationVaccines, AttenuatedAntibodies, NeutralizingAntibodies, ViralDengue VaccinesVaccines, AttenuateddengueefficacyimmunogenicitypersistencesafetyTAK-003vaccine

Identifiers

PMID33319249
PMCPMC9071282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.