1. Long-term safety follow-up of children from a randomized—controlled phase II b proof—of—concept efficacy study of the live, attenuated, tetravalent dengue vaccine (CYD—TDV) in Thailand
- Author
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Sophia Gailhardou, Edith Langevin, T. Anh Wartel, Danaya Chansinghakul, Weerawan Hattasingh, Alain Bouckenooghe, Kriengsak Limkittikul, Carina Frago, Wut Dulyachai, and Arunee Sabchareon
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medicine.medical_specialty ,education.field_of_study ,lcsh:Arctic medicine. Tropical medicine ,lcsh:RC955-962 ,business.industry ,030231 tropical medicine ,Population ,General Medicine ,medicine.disease ,Confidence interval ,Dengue fever ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Relative risk ,medicine ,Long term safety ,cyd-tdv dengue vaccine hospitalized dengue severe dengue vîrologtically confirmed dengue ,education ,Adverse effect ,business ,Dengue vaccine ,Efficacy Study - Abstract
Objective: To investigate the long-term safety of a tetravalent dengue vaccine (CYD-TDV) in children in a phase Π b follow-up study in Thailand. Methods: In the phase Π b study, children aged 4-11 years were randomized (2:1) to receive three injections of CYD-TDV or serve as control at 6-month intervals, with 25 months’ active follow-up (active phase). This study was an additional four-year passive surveillance for hospitalized virologically-confirmed dengue (VCD; hospital phase). Cases of hospitalized VCD, severe hospitalized VCD, vaccine-related serious adverse events, and deaths were reported for the total population, with post-hoc analyses by enrollment age (
- Published
- 2019
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