NCT00740155

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

Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.

Conditions

• Dengue Virus
• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)	0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
BIOLOGICAL	Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)	0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
BIOLOGICAL	Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)	0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
BIOLOGICAL	Tetravalent CYD-1,2,3,4 Dengue (Vero)	0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
BIOLOGICAL	JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)	0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-10-01
• Completion: 2010-01-01
• First posted: 2008-08-22
• Last updated: 2015-03-03

Locations

2 sites across 1 country: Mexico