Evidence map›Paper›PMID 24189367›Full record

Trial reportThe American journal of tropical medicine and hygiene2013

Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil.

Gustavo H Dayan, Pedro Garbes, Fernando Noriega, Ana Daniela Izoton de Sadovsky, Patricia Marques Rodrigues, Camila Giuberti, Reynaldo Dietze

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01187433 (Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America), which is not on this map. Cited by 34 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 3 pooled it
9.1field-weighted citation impact, top 2% of its field
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.

NCT01187433 phase2completednot on this map

Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2010 to 2012Enrolled150ConditionsDengue, Dengue Hemorrhagic FeverArmsLive, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus, NaCl 0.9%, Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed, Meningococcal A+C vaccine
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
  2. Systematic review of dengue vaccine efficacy.BMC infectious diseases · 2019
    Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Article
  13. Review
  14. Dengue: A Minireview.Viruses · 2020
    Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. A review of Dengvaxia®: development to deployment.Human vaccines & immunotherapeutics · 2019
    Review
  20. 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

7 authors at 3 institutions in 2 countries.

Gustavo H Dayan
Pedro Garbes
Fernando Noriega
Ana Daniela Izoton de Sadovsky
Patricia Marques Rodrigues
Camila Giuberti
Reynaldo Dietze
Sanofi (Brazil) · BRSanofi (United States) · USUniversidade Federal do Espírito Santo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immunogenicity and safety of a recombinant, live-attenuated, tetravalent dengue disease vaccine (CYD-TDV) was evaluated in children/adolescents in Brazil. In this observer-blind, placebo-controlled, phase II single-center study, children/adolescents (ages 9-16 years) were randomized to receive CYD-TDV or placebo at 0, 6, and 12 months. Immunogenicity was assessed using a 50% plaque neutralization test. Overall, 150 participants were enrolled (CYD-TDV: N = 100; placebo: N = 50). Injection site pain and headache were the most common solicited injection site and systemic reactions. Unsolicited adverse events (AEs) and serious AEs were similar between groups. No serious AEs were vaccine-related. Geometric mean titers against all dengue virus serotypes increased with CYD-TDV vaccination and were 267, 544, 741, and 432 1/dil for serotypes 1-4, respectively, after dose 3, representing a mean fold increase from baseline of 5, 6, 6, and 20, respectively. CYD-TDV vaccination elicited a neutralizing antibody response against serotypes 1-4 and was well-tolerated in children/adolescents in a dengue-endemic region.

Indexed as

AdolescentAntibodies, NeutralizingAntibodies, ViralBrazilChildCohort StudiesDengueDengue VaccinesDengue VirusFemaleHeadacheHumansInjections, SubcutaneousMaleSingle-Blind MethodVaccinationAntibodies, NeutralizingAntibodies, ViralDengue VaccinesVaccines, Synthetic

Identifiers

PMID24189367
PMCPMC3854882
OpenAlexW2133598290

What OpenQuestion holds

Textmetadata
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.