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

NCT06898775 | Active Not Recruiting

• 1 other identifier: Fundación Vacunar
• Study Type: observational
• Target: 112,345
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue Vaccines

Keywords

Dengue; vaccine; safety; passive surveillance; AEFI; TAK-003; Argentina

Outcome Measures

Primary Outcomes (1)

• Incidence of AEFI

  The incidence of AEFI will be calculated in terms of the number of notifications per 1,000 doses administered.

  42 days

Study Arms (1)

Individuals vaccinated with Qdenga at Vacunar centers since November 2023- Nov 2024

Participants 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

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People vaccinated with dengue vaccine, TAK-003 at private vaccination centers in Buenos Aires, Argentina

You may qualify if:

• 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.

You may not qualify if:

• Reports with insufficient information to characterize the AEFI will be excluded from the analysis.

Sponsors & Collaborators

• Fundación Vacunar: lead

Study Sites (1)

Fundación Vacunar

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 27, 2025
• Study Start: November 1, 2023
• Primary Completion: December 15, 2024
• Study Completion: June 1, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AR (1)