dc.contributor.authorVannice, Kirsten S.
dc.contributor.authorWilder-Smith, Annelies
dc.contributor.authorBarrett, Alan D.T.
dc.contributor.authorCarrijo, Kalinka
dc.contributor.authorCavaleri, Marco
dc.contributor.authorde Silva, Aravinda
dc.contributor.authorDurbin, Anna P.
dc.contributor.authorEndy, Tim
dc.contributor.authorHarris, Eva
dc.contributor.authorInnis, Bruce L.
dc.contributor.authorKatzelnick, Leah C.
dc.contributor.authorSmith, Peter G.
dc.contributor.authorSun, Wellington
dc.contributor.authorThomas, Stephen J.
dc.contributor.authorHombach, Joachim
dc.date.accessioned2018-07-13T06:35:38Z
dc.date.available2018-07-13T06:35:38Z
dc.date.issued2018
dc.identifier.citationVannice, K. S., Wilder-Smith, A., Barrett, A. D. T., Carrijo, K., Cavaleri, M., de Silva, A., et al. (2018). Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines. Vaccine, 36(24), 3411-3417.en_US
dc.identifier.issn0264-410Xen_US
dc.identifier.urihttp://hdl.handle.net/10220/45083
dc.description.abstractLicensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines.en_US
dc.format.extent7 p.en_US
dc.language.isoenen_US
dc.relation.ispartofseriesVaccineen_US
dc.rights© 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).en_US
dc.subjectDengueen_US
dc.subjectDengue vaccineen_US
dc.titleClinical development and regulatory points for consideration for second-generation live attenuated dengue vaccinesen_US
dc.typeJournal Article
dc.contributor.schoolLee Kong Chian School of Medicine (LKCMedicine)en_US
dc.identifier.doihttp://dx.doi.org/10.1016/j.vaccine.2018.02.062
dc.description.versionPublished versionen_US


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