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Cohort Event Monitoring for Dengvaxia®, CYD-TDV Dengue Vaccine

Ensayo de Sanofi en Dengue Fever · Dengue Hemorrhagic Fever (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

30.000

previstos

Fin del objetivo primario

dic 2022

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en dic 2016.

Qué mide

Percentage of subjects with selected adverse events leading to a medical consultation, emergency room visit or hospitalization occurring during the short term surveillance period of 6 months after each dose of Dengvaxia® (6 months post-vaccination) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe aim of this study is to evaluate the safety profile of Dengvaxia® when used in the real-world immunization setting Primary Objective: * To measure the incidence of selected adverse events (AEs) and serious AEs (SAEs) occurring over a period of six (6) months after each Dengvaxia® dose administration; * To quantify the association between Dengvaxia® and each of the selected AEs and SAEs for which a risk window after vaccination can be defined, using estimates of relative risk * To monitor the occurrence and frequency of hospitalized dengue disease as well as any other SAEs leading to hospitalization or death, including new and previously unrecognized SAEs, following Dengvaxia® administration on a longer term (up to 5 years after the first Dengvaxia® dose administration. Secondary objectives: * To identify risk factors for hospitalized dengue disease (severe or not) among subjects vaccinated with Dengvaxia®; * To describe the frequency of hospitalized dengue disease and/or other SAEs or selected AEs according to the number of Dengvaxia® doses and/or interval between doses.

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Ficha completa en ClinicalTrials.gov (NCT02948933), actualizada en sep 2024.