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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00239577 |
This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.
Condition | Intervention | Phase |
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Dengue |
Biological: Live attenuated tetravalent dengue vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Observer-Blind, Single Center, Controlled Study of 2 Doses of Various Formulations of the WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to a Placebo Control, Administered on a 0-6-Mth Schedule, to Healthy Adults |
Estimated Enrollment: | 132 |
Study Start Date: | April 2006 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Subjects will be randomized into one of 6 groups. One group will receive a placebo vaccine and the others will receive one of 5 different dengue vaccine formations. Each subject will receive two doses six months apart. Study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Exclusion:
History of:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 103996 |
Study First Received: | October 13, 2005 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00239577 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Dengue infection |
Fever Virus Diseases Hemorrhagic Fevers, Viral Dengue Dengue Fever |
Viral Hemorrhagic Fever Hemorrhagic Fever Healthy Arbovirus Infections Dengue Hemorrhagic Fever |
Virus Diseases Hemorrhagic Fevers, Viral RNA Virus Infections Flaviviridae Infections |
Flavivirus Infections Dengue Arbovirus Infections Dengue Hemorrhagic Fever |