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
© 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...
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th-mahidol.514402020-01-27T16:33:25Z 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 Kriengsak Limkittikul Weerawan Hattasingh Danaya Chansinghakul Arunee Sabchareon Wut Dulyachai Carina Frago T. Anh Wartel Edith Langevin Sophia Gailhardou Alain Bouckenooghe Sanofi Pasteur SA Mahidol University Ratchaburi Regional Hospital Sanofi Pasteur Sanofi Pasteur Medicine © 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. 2020-01-27T09:33:25Z 2020-01-27T09:33:25Z 2019-09-01 Article Asian Pacific Journal of Tropical Medicine. Vol.12, No.9 (2019), 396-403 10.4103/1995-7645.267582 19957645 2-s2.0-85073148888 https://repository.li.mahidol.ac.th/handle/123456789/51440 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85073148888&origin=inward |
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Medicine 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 |
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© 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. |
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Sanofi Pasteur SA |
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Sanofi Pasteur SA Kriengsak Limkittikul Weerawan Hattasingh Danaya Chansinghakul Arunee Sabchareon Wut Dulyachai Carina Frago T. Anh Wartel Edith Langevin Sophia Gailhardou Alain Bouckenooghe |
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Kriengsak Limkittikul Weerawan Hattasingh Danaya Chansinghakul Arunee Sabchareon Wut Dulyachai Carina Frago T. Anh Wartel Edith Langevin Sophia Gailhardou Alain Bouckenooghe |
author_sort |
Kriengsak Limkittikul |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publishDate |
2020 |
url |
https://repository.li.mahidol.ac.th/handle/123456789/51440 |
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1763488689095180288 |