Clinical Trial

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

Active, Not Recruiting
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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 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.
Trial Details
NCT Number NCT06898775
Lead Sponsor Fundación Vacunar
Conditions Dengue Vaccines
Enrollment 112,345 participants
Start Date 2023-11-01
Primary Completion 2024-12-15 (estimated)
Study Completion 2025-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-27