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Dengue Vaccine's Real-World safety under the microscope

NCT ID NCT06898775

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 are reviewing safety reports from people who received the Qdenga dengue vaccine at private vaccination centers in Buenos Aires. The review covers reports collected during the 2023 and 2024 dengue seasons. The goal is to see how often side effects were reported after vaccination and whether the vaccine's real-world safety matches what clinical trials showed, especially for adults over 60.

What this could mean

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

Active substance
Qdenga dengue vaccine (TAK-003)
What this could lead to
If the review finds the vaccine's real-world safety matches its clinical trial profile, it could strengthen confidence in dengue vaccination programs, including for older adults.
What could go wrong
This is a retrospective review of reports from private clinics, so it may miss side effects that were not reported or that occurred outside these centers. It cannot prove the vaccine caused any specific reaction.

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

112,345 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

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, Argentina

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 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: * 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.