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

Active, not recruiting

• Conditions: Dengue Vaccines

• Registration Number: NCT06898775
• Lead Sponsor: Fundación Vacunar

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-12-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 112345

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of AEFI	42 days	The incidence of AEFI will be calculated in terms of the number of notifications per 1,000 doses administered.

Trial Locations

Locations (1)

Fundación Vacunar; 🇦🇷 Buenos Aires, Argentina