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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07812142

Enrollment

94526

Registered

2026-09-10

Start date

2024-11-02

Completion date

2026-12-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Vaccines

Keywords

Dengue, TAK003, Vacunar, Restrospective analysis, vaccine, safety, passive surveillance, AEFI, Argentina

Brief 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.

Interventions

BIOLOGICALTak-003

Q- Denga vaccine in population \>4 years without age limit

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
1- Incidence of adverse events following immunization (AEFI) 2- Overall notification of adverse events following immunization (AEFI)	November 2, 2024 - November 1, 2025	Incidence of adverse events following immunization (AEFI): notification rate per 1,000 doses administered during the period November 2, 2024-November 1, 2025. and overall notification rate over the full two year implementation.

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026