Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025
Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 10 papers.
What it found
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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.
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.
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
Who cites it
10 citing papers in PubMed.
- Severe Dengue in Children: Pathogenesis, Early Recognition, and Evidence-Informed Management.Tropical medicine and infectious disease · 2026Review
- Article
- From promise to pitfalls: immunological lessons from dengue vaccines and their implications.NPJ vaccines · 2026Review
- Update on efficacy, safety, and immunogenicity of Dengue vaccines: a systematic review and meta-analysis.Le infezioni in medicina · 2026Review
- Mapping immune responses to TAK-003 dengue vaccine: immunogenicity across the clinical development program.Frontiers in immunology · 2026Review
- Antibody response to Aedes aegypti D7L1 + 2 salivary proteins as marker of aggregate vector exposure and correlate of dengue virus susceptibility.PLoS neglected tropical diseases · 2025Article
- From Antibodies to Immunity: Assessing Correlates of Flavivirus Protection and Cross-Reactivity.Vaccines · 2025Review
- Dengue Vaccination: A Practical Guide for Clinicians.Vaccines · 2025Review
- Age-specific kinetics of neutralizing antibodies and infection enhancement among ≤1 year-old Indian infants.Frontiers in cellular and infection microbiology · 2025Article
- BCG cell wall skeleton augments the immunogenicity of dengue nanoparticle vaccines by promoting dendritic cell activation.PloS one · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
14 authors.
Funding
Abstract
backgroundDengue is an increasing threat to global health. This exploratory analysis evaluated the immunogenicity, safety, and vaccine efficacy (VE) of a live-attenuated tetravalent dengue vaccine (TAK-003) in participants enrolled in the phase 3 DEN-301 trial (NCT02747927), stratified by baseline age (4-5 years, 6-11 years, or 12-16 years).
methodsParticipants were randomized 2:1 to receive 2 doses of TAK-003, administered 3 months apart, or placebo. Dengue serostatus was evaluated at enrolment. VE against virologically confirmed dengue (VCD) and hospitalized VCD; immunogenicity (geometric mean titers [GMTs]); and safety were evaluated per age group through ∼4 years postvaccination.
resultsVE against VCD across serotypes was 43.5% (95% confidence interval [CI]: 25.3%, 57.3%) for 4-5 year-olds; 63.5% (95% CI: 56.9%, 69.1%) for 6-11 year-olds, and 67.7% (95% CI: 57.8%, 75.2%) for 12-16 year-olds. VE against hospitalized VCD was 63.8% (95% CI: 21.1%, 83.4%), 85.1% (95% CI: 77.1%, 90.3%), and 89.7% (95% CI: 77.9%, 95.2%), for the 3 age groups, respectively. GMTs remained elevated against all 4 serotypes for ∼4 years postvaccination, with no evident differences across age groups. No clear differences in safety by age were identified.
conclusionsThis exploratory analysis shows TAK-003 was efficacious in dengue prevention across age groups in children and adolescents 4-16 years of age living in dengue endemic areas. Relatively lower VE in 4-5 year-olds was potentially confounded by causative serotype distribution, small sample size, and VE by serotype, and should be considered in benefit-risk evaluations in this age group.
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