Trials / Active Not Recruiting
Active Not RecruitingNCT06898775
Passive Safety Surveillance Data of Dengue Vaccine, Qdenga (TAK 003) in Private Vaccination Sites in Buenos Aires, Argentina.
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
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 112,345 (actual)
- Sponsor
- Fundación Vacunar · Academic / Other
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2024-12-15
- Completion
- 2025-06-01
- First posted
- 2025-03-27
- Last updated
- 2025-03-27
Locations
1 site across 1 country: Argentina
Source: ClinicalTrials.gov record NCT06898775. Inclusion in this directory is not an endorsement.