Dengue Vaccines
Conditions
Keywords
Dengue, vaccine, safety, passive surveillance, AEFI, TAK-003, Argentina
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.
Interventions
None listed
Sponsors
Fundación Vacunar
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEFI | 42 days | The incidence of adverse events following immunization (AEFI) will be calculated in terms of the number of notifications per 1,000 doses administered. |
Countries
Argentina
Outcome results
None listed