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

Phase 2

Completed

• Conditions: Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus; Dengue Diseases
• Interventions: Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero); Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero); Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)

• Registration Number: NCT00740155
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study First Submitted: 2008-05-07
• Study Start: 2008-08
• Study First Submitted QC: 2008-08-21
• Study First Posted: 2008-08-22
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)	-
Group 3	Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)	-
Group 4	Tetravalent CYD-1,2,3,4 Dengue (Vero)	-
Group 2	Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)	-

Primary Outcome Measures

Name	Time	Method
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine	12 months post-vaccination