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| Sponsor: | U.S. Army Office of the Surgeon General |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Walter Reed Army Institute of Research (WRAIR) |
| ClinicalTrials.gov Identifier: | NCT00468858 |
Purpose
The purpose of this study is to evaluate the safety and effectiveness of two different formulations of an investigational dengue vaccine (T-DEN) against a placebo vaccine when two doses are given six months apart to adults and children.
| Condition | Intervention | Phase |
|---|---|---|
|
Dengue Fever Dengue Hemorrhagic Fever Dengue Shock Syndrome |
Biological: Tetravalent live attenuated dengue vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase II, Randomized, Double-blind, Placebo-controlled Study of Two Doses of WRAIR Live Attenuated Tetravalent Dengue Vaccine Formulations, Administered Six Months Apart, to Healthy Adults and Children |
| Estimated Enrollment: | 720 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
In this study, children and adults at multiple sites in Puerto Rico will be randomly allocated to receive one of two T-DEN formulations or placebo. Subjects will be stratified by age group (a specific number of subjects in each of 4 age groups [12 months to 50 years of age] will be enrolled). The study includes 6 scheduled visits and 4 scheduled venipunctures. Safety follow-up for dengue may require unscheduled visits and venipunctures.
Multiple DEN virus serotypes are endemic in Puerto Rico and all residents are considered to be at risk for dengue. The results of this phase II study will provide a basis for identifying the vaccine formulations which elicit neutralizing antibodies to all four dengue virus serotypes in a high proportion of vaccine recipients. The most immunogenic and well tolerated candidate formulation identified in this study will be considered for advancement to phase III development.
Eligibility| Ages Eligible for Study: | 12 Months to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Puerto Rico | |
| RCMI Clinical Research Center | |
| Rio Piedras, Puerto Rico, 00935 | |
| Dept Pediatria, Esc. De Medicina | |
| San Juan, Puerto Rico, 00936-5067 | |
| Caparra Internal Medicine Research Center | |
| Rio Grande, Puerto Rico, 00745 | |
| St Luke's Memorial Hospital | |
| Ponce, Puerto Rico, 00733 | |
| Clinical Research PR | |
| San Juan, Puerto Rico, 00909-1711 | |
| San Juan Batista Medical School | |
| Caguas, Puerto Rico, 00725 | |
| Centro de Neumologia Pediatricia | |
| San Juan, Puerto Rico, 00917 | |
| Private Practice | |
| Rio Piedras, Puerto Rico, 00926 | |
| Private Practice | |
| San Juan, Puerto Rico, 00921 | |
| Torre Medica San Vicente de Paul | |
| San German, Puerto Rico, 00683 | |
| Private Practice | |
| Carolina, Puerto Rico, 00983 | |
| Principal Investigator: | Jorge Bertran-Pasarell, MD | Dept Medicina Interna Seccion Enfermedades Infecciosas |
| Principal Investigator: | Clemente Diaz-Perez, MD | University of PR |
| Principal Investigator: | Ines O. Esquilin-Rivera, MD | University of PR |
| Principal Investigator: | Evelyn Matta-Fontanet, MD | Caparra Internal Medicine Research Center |
| Principal Investigator: | Domingo Chardon-Feliciano, MD | Ponce School of Medicine |
| Principal Investigator: | Javier Morales-Ramirez, MD | Clinical Research PR |
| Principal Investigator: | Luis Rodriguez-Carrasquillo, MD | Private Practice, PR |
| Principal Investigator: | Jose Rodriguez-Santana, MD | Centro de Neumologia pediatrica |
| Principal Investigator: | Miguel Sosa-Padilla, MD | Private Practice PR |
| Principal Investigator: | Jose Tavarez-Valle, MD | Private Practice, PR |
| Principal Investigator: | Alberto Santiago-Cornier, MD | Department of Molecular Medicine |
| Principal Investigator: | Anna Quintero, MD | San Juan Batista Medical School |
More Information
| Study ID Numbers: | GSK 106405, WIRB number20070071, HRPO 14040 |
| Study First Received: | May 1, 2007 |
| Last Updated: | January 7, 2010 |
| ClinicalTrials.gov Identifier: | NCT00468858 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Dengue Virus Live-attenuated |
Vaccine Dengue viral infection Dengue Vaccine |
|
Dengue Hemorrhagic Fever Dengue RNA Virus Infections Disease Flavivirus Infections Flaviviridae Infections Body Temperature Changes Fever |
Virus Diseases Signs and Symptoms Hemorrhagic Fevers, Viral Pathologic Processes Shock Syndrome Arbovirus Infections |