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.
Age range
9 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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®
Timeframe: 6 months post-vaccination
Percentage of subjects hospitalized with dengue disease (regardless of severity and laboratory confirmation of diagnosis) after each dose of Dengvaxia®.
Timeframe: 6 months post-vaccination
Percentage of subjects with any other serious adverse events (SAEs) occurring during the short term surveillance, and SAEs leading to hospitalization or death occurring during the long term surveillance
Timeframe: Up to 5 years post-vaccination