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OpenTrials
Completed

NCT Number: NCT06898775

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

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.

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Key information

Conditions

Dengue Vaccines Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundación Vacunar

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence of AEFI

    Time frame: 42 days

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

Sponsors and collaborators

Lead sponsor

Fundación Vacunar

Other

Registry information

Official study title

Retrospective Analysis of Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) at Private Vaccination Centers, During 2023 and 2024 Dengue Season in Buenos Aires, Argentina

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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