Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

Phase 2

Completed

• Conditions: Dengue; Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever
• Interventions: Biological: Chimeric dengue serotype (1, 2, 3, 4)

• Registration Number: NCT00730288
• Lead Sponsor: Sanofi

Brief Summary

To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine

Primary Objectives:

* To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.

* To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine

Detailed Description

This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-08
• Study Completion: 2008-01
• Study First Submitted: 2008-08-06
• Study First Submitted QC: 2008-08-06
• Study First Posted: 2008-08-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-23
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chimeric dengue serotype (1, 2, 3, 4)	Received monovalent Vero dengue vaccine in Study DIV12
2	Chimeric dengue serotype (1, 2, 3, 4)	Received Yellow fever vaccine in Study DIV12
3	Chimeric dengue serotype (1, 2, 3, 4)	Flavivirus-naive subjects

Primary Outcome Measures

Name	Time	Method
Safety: To provide information concerning the safety of ChimeriVax™	28 days post-vaccination and entire study duration
Immunogenicity: To provide information concerning the immunogenicity of ChimeriVax™	28, 60 and 180 days post vaccination