CClinicalTrials.gg
CompletedNCT06898775Updated Sep 10, 2026

Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.

An observational study in Dengue Vaccines, sponsored by Fundación Vacunar. Completed at 1 site in Argentina. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Fundación Vacunar · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
112,345
Ages
4 Years and older
Sex
All
01

Study summary

The TAK-003 vaccine, Qdenga, developed by Takeda, was approved by ANMAT in April 2023 and has been available in Argentina since November 2023 for individuals from 4 years old and without limit of age. Clinical trials demonstrate that Qdenga has a favorable safety profile, adequate immunogenicity for all four serotypes, and efficacy in preventing severe dengue in seropositive and seronegative subjects. However, there are currently limited real-world safety studies on TAK-003, particularly for adults over 60 years old.

The aim of this study is to evaluate Adverse Events Supposedly Attributed to Vaccination and Immunization (AEFI) for TAK-003 vaccine in vaccinated people at private vaccination centers in Buenos Aires metropolitan area.

02

Conditions studied

  • Dengue Vaccines

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Keywords

  • Dengue
  • vaccine
  • safety
  • passive surveillance
  • AEFI
  • TAK-003
  • Argentina
03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 112,345 is above the median of 595 across 78 observational studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Fundación Vacunar is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

People vaccinated with dengue vaccine, TAK-003 at private vaccination centers in Buenos Aires, Argentina

Inclusion criteria

  • All individuals who were vaccinated with Qdenga at Vacunar centers since November 2023 still 1st November 2024, from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems.

Exclusion criteria

Exclusion Criteria:

  • Reports with insufficient information to characterize the AEFI will be excluded from the analysis.
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Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
112,345 participants (actual)
Patient registry
No

Groups and cohorts

  • Individuals vaccinated with Qdenga at Vacunar centers since November 2023- Nov 2024

    Participants from 4 years of age with no upper limit in accordance with ANMAT approval and for whom safety data is available through the Vacunar centers passive surveillance systems

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What researchers measure

Primary outcomes

  1. Incidence of AEFI

    The incidence of adverse events following immunization (AEFI) will be calculated in terms of the number of notifications per 1,000 doses administered.

    Time frame: 42 days

07

Study locations

1 site
  • Fundación Vacunar
    Buenos Aires, Argentina
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06898775
Lead sponsor
Fundación Vacunar
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Nov 1, 2023
Primary completion
Dec 15, 2024
Completion
May 1, 2025
Last update
Sep 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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