Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents
New England Journal of Medicine·
- DOI
- 10.1056/nejmoa1903869
- PMID
- 31693803
- PMCID
- —
- OpenAlex
- W2987109794
- Study type
- Randomised controlled trial
- Publisher
- Massachusetts Medical Society
- Article type
- journal-article
- Integrity
- current
Why this research matters now
Dengue was designated a WHO top 10 global health threat in 2019. This vaccine showed high efficacy against symptomatic and severe dengue in endemic settings, supporting its potential as a public health intervention for disease-endemic countries.
Structured evidence summary
Research question
The trial evaluated the efficacy of a tetravalent dengue vaccine candidate (TAK-003) in preventing symptomatic dengue in children and adolescents living in endemic areas of Asia and Latin America.
Study design
Phase 3 randomized controlled trial with 2:1 vaccine-to-placebo allocation, stratified by age and region. Participants received two doses three months apart and were monitored for virologically confirmed dengue via serotype-specific RT-PCR.
Population and setting
The study enrolled 20,071 healthy children and adolescents aged 4 to 16 years in dengue-endemic regions of Asia and Latin America. Approximately 27.7% of the per-protocol population was seronegative at baseline.
Main findings
Overall vaccine efficacy against virologically confirmed dengue was 80.9% in the safety population and 80.2% in the per-protocol analysis. Efficacy against dengue requiring hospitalization was 95.4%. Among baseline seronegative participants, efficacy was 74.9%. The incidence of serious adverse events was similar between vaccine and placebo groups.
Public-health relevance
Dengue was designated a WHO top 10 global health threat in 2019. This vaccine showed high efficacy against symptomatic and severe dengue in endemic settings, supporting its potential as a public health intervention for disease-endemic countries.
Important limitations
This summary relies on the supplied single-article abstract and metadata. Full interpretation of efficacy by serotype, long-term safety, duration of protection, and subgroup performance requires access to the complete published manuscript.
GIDS interpretation
The article is indexed under dengue, treatment, vaccination, and vaccine effectiveness topics. It represents a landmark efficacy trial for TAK-003 and would be discoverable in surveillance queries tracking dengue vaccine development or intervention evidence in endemic regions.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 12 auditable classifier relationships to diseases, places, topics, and study design.