A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children

Summary

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.

Conditions

• Dengue Fever
• Dengue Hemorrhagic Fever
• Dengue Shock Syndrome

Interventions

OTHER

Placebo

Lyophilized, single dose vials and sterile water for \> injection; 0.5 mL dose; Vaccination schedule: 0, 6 months

BIOLOGICAL

T-DEN-Post-Transfection F17

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

BIOLOGICAL

T-DEN-Post-Transfection F19

Lyophilized, single dose vials and sterile water for injection; 0.5 mL dose at 0 and 6 months

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• U.S. Army Medical Research and Development Command

  lead FED

Principal Investigators

• Jorge Bertran-Pasarell, MD · Dept Medicina Interna Seccion Enfermedades Infecciosas

• Clemente Diaz-Perez, MD · University of PR

• Ines O. Esquilin-Rivera, MD · University of PR

• Evelyn Matta-Fontanet, MD · Caparra Internal Medicine Research Center

• Domingo Chardon-Feliciano, MD · Ponce School of Medicine

• Javier Morales-Ramirez, MD · Clinical Research PR

• Luis Rodriguez-Carrasquillo, MD · Private Practice, PR

• Jose Rodriguez-Santana, MD · Centro de Neumologia pediatrica

• Miguel Sosa-Padilla, MD · Private Practice PR

• Jose Tavarez-Valle, MD · Private Practice, PR

• Alberto Santiago-Cornier, MD · Department of Molecular Medicine

• Anna Quintero, MD · San Juan Batista Medical School

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2010-04-30

Completion

2010-04-30

Countries

• Puerto Rico

Study Locations