Publication: 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
Issued Date
2019-09-01
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19957645
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2-s2.0-85073148888
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Mahidol University
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SCOPUS
Bibliographic Citation
Asian Pacific Journal of Tropical Medicine. Vol.12, No.9 (2019), 396-403
Suggested Citation
Kriengsak Limkittikul, Weerawan Hattasingh, Danaya Chansinghakul, Arunee Sabchareon, Wut Dulyachai, Carina Frago, T. Anh Wartel, Edith Langevin, Sophia Gailhardou, Alain Bouckenooghe 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. Asian Pacific Journal of Tropical Medicine. Vol.12, No.9 (2019), 396-403. doi:10.4103/1995-7645.267582 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51440
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Title
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
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Abstract
© 2019 Wolters Kluwer Medknow Publications. All rights reserved. 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 (<9 and years). Results: Of 3 997 participants receiving injection, 80.1% were recruited to the hospital phase [2 131 (CYD-TDV); 1 072 (control)]. Eighty-five hospitalized VCD cases were reported in the CYD-TDV group and 46 in the control group during the four-year hospital phase [relative risk (RR): 0.93, 95% confidence interval (CI): 0.64-1.36]. The RR over six years of follow-up was 0.77 (95% CI: 0.57-1.05). In those aged ≥9 years, the cumulative RRs in the active phase, hospital phase, and entire six years were 0.28 (95% CI: 0.08-0.81), 0.51 (95% CI: 0.25-1.05), and 0.42 (95% CI: 0.24-0.75), respectively. In the overall population, there were ten severe hospitalized VCD cases in the CYD-TDV group and five in the control group over six years (RR: 1.00, 95% CI: 0.31-3.75). Conclusions: Over six years of follow-up, in children aged ≥9 years, CYD-TDV administration is associated with a reduced risk of hospitalized VCD.