Evidence map›Paper›PMID 33822015›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021

Analysis of Hospitalized and Severe Dengue Cases Over the 6 years of Follow-up of the Tetravalent Dengue Vaccine (CYD-TDV) Efficacy Trials in Asia and Latin America.

Rémi Forrat, Gustavo H Dayan, Carlos A DiazGranados, Matthew Bonaparte, Thelma Laot, Maria Rosario Capeding, Leilani Sanchez, Diana Leticia Coronel, Humberto Reynales, Danaya Chansinghakul and 13 more

4 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–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.

NCT00842530 phase2completednot on this map

Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2009 to 2014Enrolled4,002ConditionsDengue Virus, Dengue Fever, Dengue Hemorrhagic Fever, Dengue DiseasesArmsCYD Dengue Vaccine, Inactivated rabies virus vaccine, Placebo
NCT01373281 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2017Enrolled10,275ConditionsDengue, Dengue Fever, Dengue Hemorrhagic FeverArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: Sodium chloride (NaCl) 0.9%
NCT01374516 phase3completednot on this map

Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2011 to 2018Enrolled20,869ConditionsDengue Fever, Dengue Hemorrhagic Fever, DengueArmsLive, attenuated, dengue serotype 1, 2, 3, 4 virus, Placebo: (NaCl) 0.9% solution
NCT01983553 completednot on this map

Long-Term Follow-Up of Hospitalized Dengue and Safety in Thai Children Who Were Included in an Efficacy Study of a Tetravalent Dengue Vaccine

TypeobservationalSponsorSanofi Pasteur, a Sanofi CompanyRan2013 to 2016Enrolled3,203ConditionsDengue, Dengue Fever, Dengue Hemorrhagic Fever
3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Review
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  7. Impact of prior dengue infection on severity and outcomes: meta-analysis of placebo-controlled trials.Revista panamericana de salud publica = Pan American journal of public health · 2024
    Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Dengue Vaccine: Recommendations of the Advisory Committee on Immunization Practices, United States, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Article
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

23 authors.

Rémi ForratClinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France.
Gustavo H DayanClinical Sciences Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Carlos A DiazGranadosClinical Sciences Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Matthew BonaparteTranslation Sciences and Biomarkers, Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Thelma LaotGlobal Clinical Science, Sanofi Pasteur, Taguig City, Philippines.
Maria Rosario CapedingResearch Institute for Tropical Medicine, Medical Department, Muntinlupa, Philippines.
Leilani SanchezGlobal Clinical Science, Sanofi Pasteur, Taguig City, Philippines.
Diana Leticia CoronelClinical Sciences, Sanofi Pasteur, Mexico City, Mexico.
Humberto ReynalesCentro de Atencion e Investigación Médica, Caimed S.A.S, Bogotá, Colombia.
Danaya ChansinghakulResearch & Development, Sanofi Pasteur, Bangkok, Thailand.
Sri Rezeki S HadinegoroCipto Mangunkusumo Hospital, University of Indonesia, Jakarta, Indonesia.
Ana Paula PerroudClinical Sciences, Sanofi Pasteur, São Paulo, Brazil.
Carina FragoClinical Sciences, Sanofi Pasteur, Singapore.
Betzana ZambranoClinical Sciences, Sanofi Pasteur, Uruguay.
Tifany MachabertClinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France.
Yukun WuClinical Sciences Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Alexander LuedtkeVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Brenda PriceVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Claire VigneClinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France.
Owen HaneyGlobal Pharmacovigilance, Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Stephen J SavarinoTranslation Sciences and Biomarkers, Sanofi Pasteur, Swiftwater, Pennsylvania, USA.
Alain BouckenoogheClinical Sciences, Sanofi Pasteur, São Paulo, Brazil.
Fernando NoriegaClinical Sciences Sanofi Pasteur, Swiftwater, Pennsylvania, USA.

Funding

Sanofi Pasteur
6 · The paper itself

Abstract

backgroundCYD-TDV, a live, attenuated, tetravalent dengue vaccine, has been approved for the prevention of symptomatic dengue in previously dengue exposed individuals. This post hoc analysis assessed hospitalized and severe virologically confirmed dengue (VCD) over the complete 6-year follow-up of 3 CYD-TDV efficacy studies (CYD14, CYD15, and CYD23/CYD57).

methodsThe main outcomes were hazard ratios (HRs) for hospitalized or severe VCD by baseline dengue serostatus, focusing on those who were seropositive, and by age at immunization (<9 years/≥9 years). Baseline dengue serostatus was measured or inferred using several methods. Hospitalized VCD cases were characterized in terms of clinical signs and symptoms and wild-type viremia level. Antibody persistence was assessed up to 5 years after the last injection.

resultsIn those aged ≥9 years and baseline seropositive, CYD-TDV protected against hospitalized and severe VCD over 6 years compared to placebo (HR [95% confidence interval] multiple imputation from month 0 method, .19 [.12-.30] and .15 [.06-.39]; other methods were consistent). Vaccine protection was observed over the different study periods, being highest during the first 2 years. Evidence for a decreased risk of hospitalized and severe VCD was also observed in seropositive participants aged 6-8 years. Clinical signs and symptoms, and quantified dengue viremia from participants with hospitalized VCD were comparable between groups.

conclusionsCYD-TDV demonstrated robust protection against hospitalized and severe VCD over the entire 6-year follow-up in participants who were seropositive and ≥9 years old. Protection was also observed in seropositive 6-8 year-olds. Clinical Trials Registration: NCT00842530, NCT01983553, NCT01373281, NCT01374516.

Indexed as

DengueDengue VaccinesDengue VirusSevere DengueAntibodies, ViralAsiaChildFollow-Up StudiesHumansLatin AmericaVaccines, AttenuatedVaccines, CombinedAntibodies, ViralDengue VaccinesVaccines, AttenuatedVaccines, CombinedCYD-TDVdengueserostatusVCD

Identifiers

PMID33822015
PMCPMC8442794

What OpenQuestion holds

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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.