Trial reportThe Pediatric infectious disease journal2020
Secondary Analysis of the Efficacy and Safety Trial Data of the Tetravalent Dengue Vaccine in Children and Adolescents in Colombia.
Trial report in The Pediatric infectious disease journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01374516 (Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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.
Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.
- Dengue vaccine effectiveness and safety: a systematic analysis of recent clinical trial data.Virology journal · 2025Pooled it
- Post-marketing safety profile of dengue vaccines CYD-TDV and TAK-003: analysis of adverse event reports from a European database.Frontiers in pharmacology · 2026Article
- Toward a Categorization of Virus-ncRNA Interactions in the World of RNA to Disentangle the Tiny Secrets of Dengue Virus.Viruses · 2024Review
- Dengue Fever Epidemics and the Prospect of Vaccines: A Systematic Review and Meta-Analysis Using Clinical Trials in Children.Diseases (Basel, Switzerland) · 2024Review
- Recent Insights Into the Molecular Mechanism of Toll-Like Receptor Response to Dengue Virus Infection.Frontiers in microbiology · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe efficacy of the recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) against virologically-confirmed dengue (VCD) has been documented in a phase 3 trial in Latin America (CYD15, NCT01374516). This is a descriptive secondary analysis of the efficacy and safety of CYD-TDV in participants from Colombia.
methodsData from 9740 Colombian participants 9-16 years of age who were randomized 2:1 to receive CYD-TDV or placebo were assessed to describe the vaccine efficacy of CYD-TDV against VCD and severe VCD. Estimation was made of the relative risk (RR) for hospitalized VCD cases and severe hospitalized VCD cases after the first dose of CYD-TDV, as well as a description of the incidence of hospitalized dengue from the start of the study and per year of the study until study completion.
resultsDuring the active phase of the trial in Colombia, the efficacy of CYD-TDV was 67.5% [95% confidence interval (CI): 58.3-74.7] against symptomatic VCD due to any serotype from injection 1 (month 0) to 25 months postinjection 1. Over 6 years, the RR across all 4 serotypes was 0.166 (95% CI: 0.09-0.29) in hospitalized VCD patients and 0.154 (95% CI: 0.04-0.50) in patients with severe hospitalized VCD.
conclusionsAnalysis of the data from Colombia mimics the efficacy observed in CYD15 during the active surveillance follow-up (25 months), but with a sustained beneficial RR for dengue hospitalizations on the subsequent years of follow-up. In Colombia, where seroprevalence has been demonstrated to be high in several regions of the country, CYD-TDV is a useful tool to consider as part of an integrated control strategy against endemic dengue, a disease with a high economic impact on the health system.
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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.