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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00617344 |
This is a follow up study using three different formulations for each serotype with the aim of testing immunogenicity and reactogenicity
Primary Objective:
Immunogenicity: To evaluate immunogenicity by neutralizing antibody response post dose 2.
Secondary Objectives:
Safety: To evaluate safety following three formulations of ChimeriVax™ Tetravalent Dengue Vaccine.
Immunogenicity: To describe the neutralizing antibody responses after each dose.
Condition | Intervention | Phase |
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Dengue Fever Dengue Hemorrhagic Fever Dengue Virus |
Biological: ChimeriVax™ Tetravalent Dengue Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 250 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A dose at 0, 6, and 12 months, respectively.
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2: Experimental |
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A dose at 0, 6, and 12 months, respectively
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3: Experimental |
Biological: ChimeriVax™ Tetravalent Dengue Vaccine
A dose at 0, 6, and 12 months, respectively
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This is a phase II, double-blind, randomized, descriptive, multicenter study in US adult subjects. Subjects will be randomized to receive a total of three doses of ChimeriVax™ Tetravalent Dengue Vaccine from one particular formulation.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States, 35235 | |
United States, California | |
Vallejo, California, United States, 94589 | |
San Diego, California, United States, 92103 | |
United States, Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Missouri | |
Springfield, Missouri, United States, 65802 | |
United States, Tennessee | |
Knoxville, Tennessee, United States, 37920 | |
United States, Texas | |
Houston, Texas, United States, 77030 | |
United States, Washington | |
Seattle, Washington, United States, 98104 |
Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | CYD12 |
Study First Received: | February 6, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00617344 |
Health Authority: | United States: Food and Drug Administration |
Dengue fever Dengue hemorrhagic fever Dengue virus |
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 |