Evidence map›Paper›PMID 34131423›Full record

ArticleRevista panamericana de salud publica = Pan American journal of public health2021

Immunogenicity and safety of a tetravalent dengue vaccine in dengue-naïve adolescents in Mexico City.

Shibadas Biswal, Jorge Fernando Mendez Galvan, Mercedes Macias Parra, Juan-Francisco Galan-Herrera, Monica Belisa Carrascal Rodriguez, Esteban Patricio Rodriguez Bueno, Manja Brose, Martina Rauscher, Inge LeFevre, Derek Wallace and 1 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Revista panamericana de salud publica = Pan American journal of public health, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03341637 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% 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.

NCT03341637 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue

TypeinterventionalSponsorTakedaRan2017 to 2019Enrolled400ConditionsDengueArmsTetravalent Dengue Vaccine (TDV), Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Trial
  3. Trial
  4. Trial
  5. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  6. Article
  7. Review
  8. Review
  9. Exploring plant-based dengue therapeutics: from laboratory to clinic.Tropical diseases, travel medicine and vaccines · 2024
    Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. TAK-003 Dengue Vaccine Safety: Evidence from a Systematic Review and Meta-analysis of Clinical Trials.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine
    Review
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

11 authors at 5 institutions in 2 countries.

Shibadas BiswalTakeda Vaccines Inc. Boston United States of America Takeda Vaccines Inc., Boston, United States of America.
Jorge Fernando Mendez GalvanHospital Infantil de México Federico Gómez Mexico City Mexico Hospital Infantil de México Federico Gómez, Mexico City, Mexico.
Mercedes Macias ParraInstituto Nacional de Pediatría Mexico City Mexico Instituto Nacional de Pediatría, Mexico City, Mexico.
Juan-Francisco Galan-HerreraInstituto Politécnico Nacional Mexico City Mexico Instituto Politécnico Nacional, Mexico City, Mexico.
Monica Belisa Carrascal RodriguezCAIMED Investigación en Salud Mexico City Mexico CAIMED Investigación en Salud, Mexico City, Mexico.
Esteban Patricio Rodriguez BuenoMexico Center for Clinical Research Mexico City Mexico Mexico Center for Clinical Research, Mexico City, Mexico.
Manja BroseTakeda Pharmaceuticals International AG. Zurich Switzerland Takeda Pharmaceuticals International AG., Zurich, Switzerland.
Martina RauscherTakeda Pharmaceuticals International AG. Zurich Switzerland Takeda Pharmaceuticals International AG., Zurich, Switzerland.
Inge LeFevreTakeda Pharmaceuticals International AG. Zurich Switzerland Takeda Pharmaceuticals International AG., Zurich, Switzerland.
Derek WallaceTakeda Vaccines Inc. Boston United States of America Takeda Vaccines Inc., Boston, United States of America.
Astrid BorkowskiTakeda Pharmaceuticals International AG. Zurich Switzerland Takeda Pharmaceuticals International AG., Zurich, Switzerland.
Takeda (Switzerland) · CHHospital Infantil de México Federico Gómez · MXInstituto Nacional de Pediatria · MXInstituto Politécnico Nacional · MXSecretaria de Salud · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo describe the immunogenicity and safety of a tetravalent dengue vaccine (TAK-003) in healthy adolescents living in Mexico City, an area considered non-endemic for dengue (NCT03341637).

methodsParticipants aged 12-17 years were randomized 3:1 to receive two doses (Month 0 and Month 3) of TAK-003 or placebo. Immunogenicity was assessed by microneutralization assay of dengue neutralizing antibodies at baseline, Months 4 and 9. Solicited and unsolicited adverse events (AEs) were recorded after each vaccination. Serious (SAEs) and medically-attended AEs (MAAEs) were recorded throughout the study.

results400 adolescents were enrolled, 391 (97.8%) completed the study. Thirty-six (9%) were baseline seropositive to ≥1 serotypes (reciprocal titer ≥10). Geometric mean titers (GMTs) in baseline seronegative TAK-003 recipients were 328, 1743, 120, and 143 at Month 4, and 135, 741, 46, and 38 at Month 9 against DENV-1, -2, -3, and -4, respectively. Placebo GMTs remained <10. Tetravalent seropositivity rates in vaccine recipients were 99.6% and 85.8% at Months 4 and 9, respectively. One MAAE in each group was considered treatment-related (TAK-003: injection-site erythema, and placebo: pharyngitis).

conclusionTAK-003 was immunogenic against all four serotypes and was well tolerated in dengue-naïve adolescents living in Mexico City.

Indexed as

adolescentsdengueimmunogenicityMexicosafetyVaccines

Identifiers

PMID34131423
PMCPMC8196333
OpenAlexW3171396480

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.