Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines

• Main 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
• Other Authors: Lee Kong Chian School of Medicine (LKCMedicine)
• Format: Article
• Language: English
• Published: 2018
• Subjects: Dengue; Dengue vaccine
• Online Access: https://hdl.handle.net/10356/83868; http://hdl.handle.net/10220/45083
• Institution: Nanyang Technological University

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 cha...