Retrospective analysis of the second year of safety surveillance of the qdenga® (TAK-003) vaccine in private vaccination centers, including a sub-analysis of safety in adults over 60 years of age
NCT ID NCT07812142
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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 aged 4 years and older, with no upper age limit. Clinical trials demonstrate that Qdenga has a favorable safety and immunogenicity profile in individuals with and without prior dengue infection. However, real-world safety evidence remains limited, particularly in adults over 60 years of age. The aim of this study is to evaluate adverse events following immunization (AEFI) associated with TAK-003 during the second year of implementation and across the combined two-year period at private vaccination centers in the Buenos Aires metropolitan area, with a particular focus on older adults and hypersensitivity reactions.
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dengue vaccines are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fundación Vacunar
Buenos Aires, Argentina
More trials for these conditions
Other studies related to the condition(s) this trial covers.