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
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 inter...
Published in: | Asian Pacific Journal of Tropical Medicine |
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Language: | English |
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Wolters Kluwer Medknow Publications
2019
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Online Access: | https://doi.org/10.4103/1995-7645.267582 https://doaj.org/article/e0464c7186f04e73b6d1a922a29000c4 |
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ftdoajarticles:oai:doaj.org/article:e0464c7186f04e73b6d1a922a29000c4 2023-05-15T15:15:13+02:00 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 2019-01-01T00:00:00Z https://doi.org/10.4103/1995-7645.267582 https://doaj.org/article/e0464c7186f04e73b6d1a922a29000c4 EN eng Wolters Kluwer Medknow Publications http://www.apjtm.org/article.asp?issn=1995-7645;year=2019;volume=12;issue=9;spage=396;epage=403;aulast=Limkittikul https://doaj.org/toc/2352-4146 2352-4146 doi:10.4103/1995-7645.267582 https://doaj.org/article/e0464c7186f04e73b6d1a922a29000c4 Asian Pacific Journal of Tropical Medicine, Vol 12, Iss 9, Pp 396-403 (2019) cyd-tdv dengue vaccine hospitalized dengue severe dengue vîrologtically confirmed dengue Arctic medicine. Tropical medicine RC955-962 article 2019 ftdoajarticles https://doi.org/10.4103/1995-7645.267582 2022-12-31T01:54:36Z 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. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Asian Pacific Journal of Tropical Medicine 12 9 396 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
cyd-tdv dengue vaccine hospitalized dengue severe dengue vîrologtically confirmed dengue Arctic medicine. Tropical medicine RC955-962 |
spellingShingle |
cyd-tdv dengue vaccine hospitalized dengue severe dengue vîrologtically confirmed dengue Arctic medicine. Tropical medicine RC955-962 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 |
topic_facet |
cyd-tdv dengue vaccine hospitalized dengue severe dengue vîrologtically confirmed dengue Arctic medicine. Tropical medicine RC955-962 |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Kriengsak Limkittikul Weerawan Hattasingh Danaya Chansinghakul Arunee Sabchareon Wut Dulyachai Carina Frago T Anh Wartel Edith Langevin Sophia Gailhardou Alain Bouckenooghe |
author_facet |
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 |
publisher |
Wolters Kluwer Medknow Publications |
publishDate |
2019 |
url |
https://doi.org/10.4103/1995-7645.267582 https://doaj.org/article/e0464c7186f04e73b6d1a922a29000c4 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Asian Pacific Journal of Tropical Medicine, Vol 12, Iss 9, Pp 396-403 (2019) |
op_relation |
http://www.apjtm.org/article.asp?issn=1995-7645;year=2019;volume=12;issue=9;spage=396;epage=403;aulast=Limkittikul https://doaj.org/toc/2352-4146 2352-4146 doi:10.4103/1995-7645.267582 https://doaj.org/article/e0464c7186f04e73b6d1a922a29000c4 |
op_doi |
https://doi.org/10.4103/1995-7645.267582 |
container_title |
Asian Pacific Journal of Tropical Medicine |
container_volume |
12 |
container_issue |
9 |
container_start_page |
396 |
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1766345594506313728 |