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Title: Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines
Authors: Vannice, Kirsten S.
Wilder-Smith, Annelies
Barrett, Alan D.T.
Carrijo, Kalinka
Cavaleri, Marco
de Silva, Aravinda
Durbin, Anna P.
Endy, Tim
Harris, Eva
Innis, Bruce L.
Katzelnick, Leah C.
Smith, Peter G.
Sun, Wellington
Thomas, Stephen J.
Hombach, Joachim
Keywords: Dengue
Dengue vaccine
Issue Date: 2018
Source: Vannice, 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.
Series/Report no.: Vaccine
Abstract: Licensing 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.
ISSN: 0264-410X
DOI: 10.1016/j.vaccine.2018.02.062
Rights: © 2018 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (
Fulltext Permission: open
Fulltext Availability: With Fulltext
Appears in Collections:LKCMedicine Journal Articles

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