Dengue Fever Clinical Trial
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
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.
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.
>
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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