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Dengue Hemorrhagic Fever clinical trials

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NCT ID: NCT02948933 Active, not recruiting - Dengue Fever Clinical Trials

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

Start date: December 14, 2016
Phase:
Study type: Observational

The 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.