Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults

Phase 2 Completed 154 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupOpen-labelPrevention

Summary

This is part of an ongoing effort to develop a satisfactory dengue vaccine: Primary objective: To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates. To describe the immune response after each vaccination of dengue vaccine.

Timeline

Start: 2008-08
Primary completion: 2009-10
Completion: 2010-01

Publications

Results Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bivalent CYD-1,3 Dengue (Vero)	Vaccine	0.5 ml	Subcutaneous
Subject	Bivalent CYD-2,4 Dengue (Vero)	Vaccine	0.5 ml	Subcutaneous
Subject	CYD-1,3,4 Dengue (Vero)	Vaccine	0.5 ml	Subcutaneous
Subject	CYD-TDV	Vaccine	0.5 ml	Subcutaneous
Subject	VDV-2	Vaccine	0.5 ml	Subcutaneous
Comparator	JE-VAX®	Vaccine	0.5 ml	Subcutaneous

Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults

Summary

Timeline

Publications

Drugs

Indications