|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00730288 |
Purpose
To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine
Primary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Dengue Fever Dengue Hemorrhagic Fever Dengue Virus |
Biological: Chimeric dengue serotype (1, 2, 3, 4) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects Previously Immunised With an Investigational Dengue or Yellow Fever Vaccine |
| Enrollment: | 35 |
| Study Start Date: | August 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Received monovalent Vero dengue vaccine in Study DIV12
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
|
Experimental: 2
Received Yellow fever vaccine in Study DIV12
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5 mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
|
Experimental: 3
Flavivirus-naive subjects
|
Biological: Chimeric dengue serotype (1, 2, 3, 4)
0.5mL, Subcutaneous, 1 dose
Other Name: ChimeriVax™ Dengue Tetravalent Vaccine
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations
More Information
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc |
| ClinicalTrials.gov Identifier: | NCT00730288 History of Changes |
| Other Study ID Numbers: | CYD10 |
| Study First Received: | August 6, 2008 |
| Last Updated: | August 7, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: National Health and Medical Research Council |
|
Dengue Dengue fever Dengue hemorrhagic fever Dengue virus |
|
Dengue Dengue Hemorrhagic Fever Fever Hemorrhagic Fevers, Viral Arbovirus Infections Virus Diseases |
Flavivirus Infections Flaviviridae Infections RNA Virus Infections Body Temperature Changes Signs and Symptoms |