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Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.
Sponsor: Fundación Vacunar
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.
Official 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
Key Details
Gender
All
Age Range
4 Years - Any
Study Type
OBSERVATIONAL
Enrollment
112345
Start Date
2023-11-01
Completion Date
2025-06-01
Last Updated
2025-03-27
Healthy Volunteers
Yes
Conditions
Locations (1)
Fundación Vacunar
Buenos Aires, Argentina