Clinical Research Directory

Retrospective Analysis of the Second Year of Safety Surveillance of the Qdenga® (TAK-003) Vaccine in Private Vaccination Centers, Including a Sub-analysis of Safety in Adults Over 60 Years of Age

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 aged 4 years and older, with no upper age limit. Clinical trials demonstrate that Qdenga has a favorable safety and immunogenicity profile in individuals with and without prior dengue infection. However, real-world safety evidence remains limited, particularly in adults over 60 years of age. The aim of this study is to evaluate adverse events following immunization (AEFI) associated with TAK-003 during the second year of implementation and across the combined two-year period at private vaccination centers in the Buenos Aires metropolitan area, with a particular focus on older adults and hypersensitivity reactions.

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

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.

Characterisation of Dengue Vaccine-induced Specific Immunity in Vaccinees With and Without Prior Exposure to Flavivirus Infections or Vaccination

The goal of this observational study is to learn about the immunity induced by the Qdenga® vaccine in vaccinees. Participants that will receive the Dengue vaccine as part of their routine before a travel will be asked to undergo a blood sample at the time of administration of the first dose (T0), 24-48 hours after the first dose (T1) of the vaccine, immediately before the second dose (T2 ) and one to two months after the second dose (T3). Possibly a further sample will be collected within 2 years.