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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by (Responsible Party): | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00842530 |
Purpose
There is currently no vaccine against dengue and no specific drug treatment against the disease. This study is aimed at generating information on the protective effect of the vaccine.
Primary Objective To assess the efficacy of dengue vaccine after three injections in children.
Secondary Objective:
To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of children.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases |
Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4) Biological: Inactivated Rabies virus vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand |
| Enrollment: | 4002 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dengue Vaccine Group |
Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
|
| Sham Comparator: Control Vaccine Group |
Biological: Inactivated Rabies virus vaccine
0.5 mL, Subcutaneous
Other Name: Verorab®
|
Eligibility| Ages Eligible for Study: | 4 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Contacts and Locations
More Information
| Responsible Party: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00842530 History of Changes |
| Other Study ID Numbers: | CYD23 |
| Study First Received: | February 11, 2009 |
| Last Updated: | August 26, 2011 |
| Health Authority: | Thailand: Food and Drug Administration |
|
Dengue virus Dengue fever Dengue hemorrhagic fever Dengue diseases Dengue vaccine |
|
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 |