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Dengue Vaccine's Real-World safety in seniors under the microscope

NCT ID NCT07812142

Knowledge-focused Sponsor: Fundación Vacunar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers in Buenos Aires reviewed safety reports filed after people received the Qdenga dengue vaccine at private clinics over a two-year period. The review covers anyone aged 4 and older, with a special look at adults over 60 and at allergic-type reactions. The goal is to see how the vaccine's real-world safety profile compares with what clinical trials showed, since older adults were not well represented in those earlier studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
the Qdenga (TAK-003) dengue vaccine
What this could lead to
If the review finds no unexpected safety signals, it could strengthen confidence in giving the dengue vaccine to older adults, a group often left out of pre-approval trials.
What could go wrong
This is a retrospective review of reports from private clinics, so it can miss reactions that were never reported and cannot prove the vaccine caused any problem. Findings may not apply to public vaccination programs or other regions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

94,526 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

4 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All individuals vaccinated with Qdenga at Vacunar centers between November 2, 2024 and November 1, 2025, aged 4 years and older with no upper age limit, in accordance with ANMAT approval (7), and for whom safety data are available through the passive surveillance systems of Vacunar centers. Exclusion Criteria: * Reports with insufficient information to characterize the AEFI will be excluded from the analysis.

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Conditions

The condition(s) this trial relates to.

dengue disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dengue vaccines

Contacts and locations

Locations

  • Fundación Vacunar

    Buenos Aires, Argentina

More trials for these conditions

Other studies related to the condition(s) this trial covers.