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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00740155 |
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.
Condition | Intervention | Phase |
---|---|---|
Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases |
Biological: Bivalent CYD-1,3 Dengue (Vero) Biological: 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) Biological: Japanese encephalitis virus vaccine inactivated |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years |
Estimated Enrollment: | 150 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Bivalent CYD-1,3 Dengue (Vero)
0.5 mL, SC
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2: Experimental |
Biological: Bivalent CYD-2,4 Dengue (Vero)
0.5 mL, SC
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3: Experimental |
Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
0.5 mL, SC
|
4: Experimental |
Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
0.5 mL, SC
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5: Active Comparator |
Biological: Japanese encephalitis virus vaccine inactivated
0.5 mL, SC
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Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contact: Public Registry Sanofi Pasteur | RegistryContactUs@sanofipasteur.com |
Mexico | |
Recruiting | |
Tlalpan, Mexico, 14050 | |
Recruiting | |
Valle de Chalco, Mexico, 56613 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | CYD11 |
Study First Received: | May 7, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00740155 |
Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Dengue virus Dengue fever Dengue hemorrhagic fever Dengue diseases |
Virus Diseases Fever Signs and Symptoms Hemorrhagic Fevers, Viral Dengue Hemorrhagic fever |
Viral hemorrhagic fever Dengue fever Healthy Arbovirus Infections Dengue Hemorrhagic Fever |
RNA Virus Infections Flaviviridae Infections Flavivirus Infections Body Temperature Changes |